Tramatic Brain InjuryNCT07783828
AI Chatbot-Assisted Aerobic Exercise Guided by the Transtheoretical Model and Self-determination Theory With Machine Learning Algorithms to Provide Real-time, Personalized Feedback in Traumatic Brain Injury
A study testing AI-PEF in people with Tramatic Brain Injury, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
This study aims to develop and evaluate an AI-driven Personalized Exercise Feedback Program (AI-PEF) to enhance health outcomes in mTBI patients. Methods: AI-PEF integrates the transtheoretical model and self-determination theory with machine learning algorithms to provide real-time, personalized feedback. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tramatic Brain Injury
- What is being tested?
- AI-PEF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Aug 2025to 31 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants are patients aged over 18 with mild TBI (GCS 13-15)
- who can walk independently,
- reside in the Greater Taipei area,
- and possess sufficient Chinese or Taiwanese language proficiency to understand the trial
- complete self-administered questionnaires.
Who cannot join
- include individuals with severe medical conditions (e.g., respiratory failure, epilepsy, psychiatric disorders), musculoskeletal or neurological impairments
- hindering physical activity in the 6-minute walk test,
- cognitive impairments (MMSE < 24),
- frontal lobe injuries or penetrating injury causing significant psychological dysfunction.
- Patients regularly engaging in moderate-to-high-intensity aerobic exercise or participating in other studies will also be excluded to avoid bias.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, 11490
Dueng-Yuan Hueng, Ph.D, 886-2-87923310, hondy2195@gmail.com
About this study
Official title: Effects of an AI Chatbot-Assisted Aerobic Exercise Guided by the Transtheoretical Model and Self-determination Theory With Machine Learning Algorithms to Provide Real-time, Personalized Feedback on Health Outcomes in Patients With Traumatic Brain Injury
This study aims to develop and evaluate an AI-driven Personalized Exercise Feedback Program (AI-PEF) to enhance health outcomes in mTBI patients.
Methods: AI-PEF integrates the transtheoretical model and self-determination theory with machine learning algorithms to provide real-time, personalized feedback. A phased randomized controlled trial will be conducted: Phase I,small-Scale Pilot Study (Early Feedback): A single-arm pilot study with 5 patients will be conducted over four weeks to gather feedback on usability, engagement, and content clarity.Phase II assesses the program's impact on functional capacity, sleep quality and depressive symptoms, with 50 participants in a 2-arm randomized trial in 3 months.Phase III will assess the program's impact on functional capacity, sleep quality and depressive symptoms, with 50 participants of waitlist control evaluation in a two-arm randomized trial.
Read the detailed description
The study will employ a stepwise, multi-phase design, combining two-arm randomized controlled trial (RCT) to evaluate the functional capacity, sleep quality and depressive symptoms of the AI-PEF.Participants will be recruited from the neurosurgery clinics at Tri-Service General Hospital, Taipei. Recruitment will be facilitated through referrals by attending physicians and registered nurses, who will be briefed on the study protocol.
Study procedures
- Phase I (Year 1): small-Scale Pilot Study (Early Feedback for aim 1): A single-arm pilot study with 5 patients will be conducted over four weeks to gather feedback on usability, engagement, and content clarity.
- Phase II : two-arm RCT (Aim 2) Phase I will focus on evaluating the functional capacity, sleep quality and depressive symptoms of the AI-PEF intervention in mTBI patient. A two-parallel-group design will be employed, with 50 participants, 25 participants per group, randomly assigned in a 1:1 ratio to the AI-PEF group and Active control group. Over three months, AI-PEF participants will engage in personalized exercise guided by AI, while active control participants will follow standard exercise recommendations. Both qualitative and quantitative data will be collected. Assessments will occur at baseline (T0), 1month (T1),2months(T2),and 3months(T3), including fitness tracker data, questionnaires (motivation, sleep, symptoms), and semi-structured interviews. The primary outcome will be functional capacity in mTBI patients, while secondary outcomes will focus on sleep quality and depressive symptoms in mTBI patients.
- Phase III : a waitlist two-arm RCT (Aim 3):Phase III will assess the long-term impact of the AI-PEF on health outcomes through a waitlist 2-arm RCT randomly assigned to one of two groups: (1) the AI-PEF group, receiving a machine learning-powered personalized exercise program; (2) the Active control group, receiving general exercise recommendations as part of standard care in a 1:1 ratio.(3)After three months, the Active control group will receive AI-PEF interventions to be the waitlist control group, with assessments conducted at 6 months (T4). Primary outcomes, including functional capacity in mTBI patients, while secondary outcomes will focus on sleep quality and depressive symptoms in mTBI patients.It will be assessed through standardized questionnaires and qualitative interviews. These standardized questionnaires are being used in our current digital remote exercise trial in patients with mild TBI (NSTC 112-2314-B-016-007-MY2) and have performed well on physiological performance. Data will be collected and analyzed using both quantitative and qualitative methods to compare health outcomes across the two groups, identifying the efficacy of AI-PEF relative to Active control group . Procedures will adhere to the blinding and randomization protocols described in Intervention Fidelity, ensuring unbiased assignment and data collection processes. This proposed study protocol is closely aligned with those that have been successfully implemented in our previous digital exercise trial.
- Conditions
- Tramatic Brain Injury
- Being tested
- AI-PEF, Active Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-PEFBehavioural
Participants will follow a 6months walking program with five 30-minute sessions per week, progressively increasing intensity based on heart rate and effort indices. Garmin fitness trackers will monitor adherence and intensity. Remote guidance will support participants via weekly digital health messages on the LINE app, offering personalized feedback, goal reinforcement, and lifestyle recommendations. Participants will also receiThese AI feedback implementations will be tailored to complement the in-person education and will include reminders of the individualized goals set during the remote exercise intervention and consultation . The digital component will also offer a platform for patients to share their progress and seek further guidance during the scheduled in-person consultation. The use of digital AI feedback aligns with the trend of integrating technology into healthcare services, providing a convenient and accessible modality for supporting parents engaging in regular exercise.
Active ControlBehavioural
Participants in the active control group will receive standard TBI care, including Garmin-based self-monitoring and routine clinic visits at baseline (T0), 1 months (T1), 2months(T2),and 3 months (T3). These visits will include general health education and recommendations on daily physical activity. No personalized or digital exercise strategies will be provided. Participants completing the 3-month protocol will have the option to access the AI-PEF program. When active control group participants completing the 3-month protocol will have the option to access the AI-PEF program.Then participants will use AI-PEF program to be the waitlist control group after 3 months to 6months, with assessments conducted at 6 months (T4).
| Study group | Role | What they receive |
|---|---|---|
| AI-PEF | Experimental | the AI-PEF group, receiving a machine learning-powered personalized exercise program. Receives: Behavioral: AI-PEF |
| Active control group | Active comparator | the Active control group, receiving general exercise recommendations as part of standard care in a 1:1 ratio. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
Measured: T0-baseline
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
Measured: T1(1 month later)
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
Measured: T2(2 month later)
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
Measured: T3(3 month later)
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
Measured: T4(6 month later)
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Measured: T0-baseline
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Measured: T1(1 month later)
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Measured: T2(2 month later)
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Measured: T3(3 month later)
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Measured: T4(6 month later)
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Measured: T0-baseline
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Measured: T1(1 month later)
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Measured: T2(2 month later)
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Measured: T3(3 month later)
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Measured: T4(6 month later)
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Measured: T0-baseline
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Measured: T1(1 month later)
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Measured: T2(2 month later)
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Measured: T3(3 month later)
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Measured: T4(6 month later)
Secondary outcomes (50)
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the Pittsburgh Sleep Quality Index Chinese version in Taiwan's populations. Each component score of the Pittsburgh Sleep Quality Index ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global Pittsburgh Sleep Quality Index score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Measured: T0-baseline
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), higher scores indicating more severe depressive symptoms,will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Measured: T0-baseline
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms
Measured: T0(baseline)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Measured: T0( baseline)
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Measured: T0( baseline)
Advanced sleep pattern
Garmin Vivosmart 5. This wearable device will track heart rate, exercise intensity, and sleep patterns. HR will be track every second. Advanced sleep tracking in compatible Garmin devices takes into account multiple factors to help understanding of sleep. In addition to the basics, such as when participants fell asleep and when they woke up, researchers can see times when they were awake and how much time they spent in key sleep stages (light, deep, REM), and the data will be calculated by heart rate to increase its validity.
Measured: T0(baseline)
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Measured: T0( baseline)
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Measured: T0(baseline)
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Measured: T0( baseline)
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data. It is a qualitative data, not a quantitative data. The interview content covers three major questions: (1) Benefits of the walking program; (2) Experiences and challenges of the walking program; (3) The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Measured: T0(baseline)
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the Pittsburgh Sleep Quality Index Chinese version in Taiwan's populations. Each component score of the Pittsburgh Sleep Quality Index ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global Pittsburgh Sleep Quality Index score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Measured: T1(1 month later)
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the Pittsburgh Sleep Quality Index Chinese version in Taiwan's populations. Each component score of the Pittsburgh Sleep Quality Index ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global Pittsburgh Sleep Quality Index score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Measured: T2(2 month later)
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the Pittsburgh Sleep Quality Index Chinese version in Taiwan's populations. Each component score of the Pittsburgh Sleep Quality Index ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global Pittsburgh Sleep Quality Index score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Measured: T3(3 month later)
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the Pittsburgh Sleep Quality Index Chinese version in Taiwan's populations. Each component score of the Pittsburgh Sleep Quality Index ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global Pittsburgh Sleep Quality Index score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Measured: T4(6 month later)
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), higher scores indicating more severe depressive symptoms,will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Measured: T1(1 month later)
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), higher scores indicating more severe depressive symptoms,will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Measured: T2(2 month later)
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), higher scores indicating more severe depressive symptoms,will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Measured: T3(3 month later)
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), higher scores indicating more severe depressive symptoms,will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Measured: T4(6 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms
Measured: T1(1 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms
Measured: T2(2 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms
Measured: T3(3 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms
Measured: T4(6 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Measured: T1(1 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Measured: T2(2 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Measured: T3(3 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Measured: T4(6 month later)
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Measured: T1(1 month later)
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Measured: T2(2 month later)
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Measured: T3(3 month later)
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Measured: T4(6 month later)
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Measured: T1(1 month later)
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Measured: T2(2 month later)
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Measured: T3(3 month later)
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Measured: T4(6 month later)
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Measured: T1(1 month later)
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Measured: T2(2 month later)
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Measured: T3(3 month later)
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Measured: T4(6 month later)
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Measured: T1(1 month later)
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Measured: T2(2 month later)
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Measured: T3(3 month later)
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Measured: T4(6 month later)
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data. It is a qualitative data, not a quantitative data. The interview content covers three major questions: (1) Benefits of the walking program; (2) Experiences and challenges of the walking program; (3) The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Measured: T1(1 month later)
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data. It is a qualitative data, not a quantitative data. The interview content covers three major questions: (1) Benefits of the walking program; (2) Experiences and challenges of the walking program; (3) The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Measured: T2(2 month later)
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data. It is a qualitative data, not a quantitative data. The interview content covers three major questions: (1) Benefits of the walking program; (2) Experiences and challenges of the walking program; (3) The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Measured: T3(3 month later)
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data. It is a qualitative data, not a quantitative data. The interview content covers three major questions: (1) Benefits of the walking program; (2) Experiences and challenges of the walking program; (3) The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Measured: T4(6 month later)
Physiological Monitoring Tools
Participants will wear a Garmin Vivosmart 5 device during the intervention period. The device will be used to collect heart rate, physical activity, exercise intensity, and sleep-related data. Data will be synchronized with the Garmin Connect application for monitoring and data collection. Heart rate data will be recorded continuously during device use. Sleep-related variables estimated by the device include total sleep time, awake time, light sleep duration, deep sleep duration, and rapid eye movement sleep duration. Each variable will be reported separately in its corresponding outcome measure.
Measured: T1(1 month later)
Physiological Monitoring Tools
Participants will wear a Garmin Vivosmart 5 device during the intervention period. The device will be used to collect heart rate, physical activity, exercise intensity, and sleep-related data. Data will be synchronized with the Garmin Connect application for monitoring and data collection. Heart rate data will be recorded continuously during device use. Sleep-related variables estimated by the device include total sleep time, awake time, light sleep duration, deep sleep duration, and rapid eye movement sleep duration. Each variable will be reported separately in its corresponding outcome measure.
Measured: T2(2 month later)
Physiological Monitoring Tools
Participants will wear a Garmin Vivosmart 5 device during the intervention period. The device will be used to collect heart rate, physical activity, exercise intensity, and sleep-related data. Data will be synchronized with the Garmin Connect application for monitoring and data collection. Heart rate data will be recorded continuously during device use. Sleep-related variables estimated by the device include total sleep time, awake time, light sleep duration, deep sleep duration, and rapid eye movement sleep duration. Each variable will be reported separately in its corresponding outcome measure.
Measured: T3(3 month later)
Physiological Monitoring Tools
Participants will wear a Garmin Vivosmart 5 device during the intervention period. The device will be used to collect heart rate, physical activity, exercise intensity, and sleep-related data. Data will be synchronized with the Garmin Connect application for monitoring and data collection. Heart rate data will be recorded continuously during device use. Sleep-related variables estimated by the device include total sleep time, awake time, light sleep duration, deep sleep duration, and rapid eye movement sleep duration. Each variable will be reported separately in its corresponding outcome measure.
Measured: T4(6 month later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start14 Aug 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tramatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1: A single-arm pilot study with 5 patients will be conducted over four weeks to gather feedback on usability, engagement, and content clarity. Phase 2: Evaluate the health outcomes, including functional capacity, sleep quality and depressive symptoms of the AI-PEF intervention in improving mTBI patients. Phase 3:Examine the impact of the AI-PEF intervention on health outcomes through a waitlist 2-arm RCT.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Hsun Chiang, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783828
- Sponsor's protocol ID
- AI chatbot-assisted exercise
- Status last verified
- Aug 2026
- First submitted
- 20 May 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an AI Chatbot-Assisted Aerobic Exercise Guided by the Transtheoretical Model and Self-determination Theory With Machine Learning Algorithms to Provide Real-time, Personalized Feedback on Health Outcomes in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07783828
- Acronym / sponsor ID
- AI chatbot-assisted exercise
- Conditions
- Tramatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop and evaluate an AI-driven Personalized Exercise Feedback Program (AI-PEF) to enhance health outcomes in mTBI patients.
Methods: AI-PEF integrates the transtheoretical model and self-determination theory with machine learning algorithms to provide real-time, personalized feedback. A phased randomized controlled trial will be conducted: Phase I,small-Scale Pilot Study (Early Feedback): A single-arm pilot study with 5 patients will be conducted over four weeks to gather feedback on usability, engagement, and content clarity.Phase II assesses the program's impact on functional capacity, sleep quality and depressive symptoms, with 50 participants in a 2-arm randomized trial in 3 months.Phase III will assess the program's impact on functional capacity, sleep quality and depressive symptoms, with 50 participants of waitlist control evaluation in a two-arm randomized trial.
Detailed description
The study will employ a stepwise, multi-phase design, combining two-arm randomized controlled trial (RCT) to evaluate the functional capacity, sleep quality and depressive symptoms of the AI-PEF.Participants will be recruited from the neurosurgery clinics at Tri-Service General Hospital, Taipei. Recruitment will be facilitated through referrals by attending physicians and registered nurses, who will be briefed on the study protocol.
Study procedures
- Phase I (Year 1): small-Scale Pilot Study (Early Feedback for aim 1): A single-arm pilot study with 5 patients will be conducted over four weeks to gather feedback on usability, engagement, and content clarity.
- Phase II : two-arm RCT (Aim 2) Phase I will focus on evaluating the functional capacity, sleep quality and depressive symptoms of the AI-PEF intervention in mTBI patient. A two-parallel-group design will be employed, with 50 participants, 25 participants per group, randomly assigned in a 1:1 ratio to the AI-PEF group and Active control group. Over three months, AI-PEF participants will engage in personalized exercise guided by AI, while active control participants will follow standard exercise recommendations. Both qualitative and quantitative data will be collected. Assessments will occur at baseline (T0), 1month (T1),2months(T2),and 3months(T3), including fitness tracker data, questionnaires (motivation, sleep, symptoms), and semi-structured interviews. The primary outcome will be functional capacity in mTBI patients, while secondary outcomes will focus on sleep quality and depressive symptoms in mTBI patients.
- Phase III : a waitlist two-arm RCT (Aim 3):Phase III will assess the long-term impact of the AI-PEF on health outcomes through a waitlist 2-arm RCT randomly assigned to one of two groups: (1) the AI-PEF group, receiving a machine learning-powered personalized exercise program; (2) the Active control group, receiving general exercise recommendations as part of standard care in a 1:1 ratio.(3)After three months, the Active control group will receive AI-PEF interventions to be the waitlist control group, with assessments conducted at 6 months (T4). Primary outcomes, including functional capacity in mTBI patients, while secondary outcomes will focus on sleep quality and depressive symptoms in mTBI patients.It will be assessed through standardized questionnaires and qualitative interviews. These standardized questionnaires are being used in our current digital remote exercise trial in patients with mild TBI (NSTC 112-2314-B-016-007-MY2) and have performed well on physiological performance. Data will be collected and analyzed using both quantitative and qualitative methods to compare health outcomes across the two groups, identifying the efficacy of AI-PEF relative to Active control group . Procedures will adhere to the blinding and randomization protocols described in Intervention Fidelity, ensuring unbiased assignment and data collection processes. This proposed study protocol is closely aligned with those that have been successfully implemented in our previous digital exercise trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 1: A single-arm pilot study with 5 patients will be conducted over four weeks to gather feedback on usability, engagement, and content clarity. Phase 2: Evaluate the health outcomes, including functional capacity, sleep quality and depressive symptoms of the AI-PEF intervention in improving mTBI patients. Phase 3:Examine the impact of the AI-PEF intervention on health outcomes through a waitlist 2-arm RCT.
| Arm | Type | Receives |
|---|---|---|
| AI-PEF | Experimental | Behavioral: AI-PEFthe AI-PEF group, receiving a machine learning-powered personalized exercise program. |
| Active control group | Active comparator | Behavioral: Active Controlthe Active control group, receiving general exercise recommendations as part of standard care in a 1:1 ratio. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligible participants are patients aged over 18 with mild TBI (GCS 13-15)
- who can walk independently,
- reside in the Greater Taipei area,
- and possess sufficient Chinese or Taiwanese language proficiency to understand the trial
- complete self-administered questionnaires.
Key exclusion criteria (5 listed)
- include individuals with severe medical conditions (e.g., respiratory failure, epilepsy, psychiatric disorders), musculoskeletal or neurological impairments
- hindering physical activity in the 6-minute walk test,
- cognitive impairments (MMSE < 24),
- frontal lobe injuries or penetrating injury causing significant psychological dysfunction.
- Patients regularly engaging in moderate-to-high-intensity aerobic exercise or participating in other studies will also be excluded to avoid bias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-PEFParticipants will follow a 6months walking program with five 30-minute sessions per week, progressively increasing intensity based on heart rate and effort indices. Garmin fitness trackers will monitor adherence and intensity. Remote guidance will support participants via weekly digital health messages on the LINE app, offering personalized feedback, goal reinforcement, and lifestyle recommendations. Participants will also receiThese AI feedback implementations will be tailored to complement the in-person education and will include reminders of the individualized goals set during the remote exercise intervention and consultation . The digital component will also offer a platform for patients to share their progress and seek further guidance during the scheduled in-person consultation. The use of digital AI feedback aligns with the trend of integrating technology into healthcare services, providing a convenient and accessible modality for supporting parents engaging in regular exercise. | Behavioural | AI-PEF |
| Active ControlParticipants in the active control group will receive standard TBI care, including Garmin-based self-monitoring and routine clinic visits at baseline (T0), 1 months (T1), 2months(T2),and 3 months (T3). These visits will include general health education and recommendations on daily physical activity. No personalized or digital exercise strategies will be provided. Participants completing the 3-month protocol will have the option to access the AI-PEF program. When active control group participants completing the 3-month protocol will have the option to access the AI-PEF program.Then participants will use AI-PEF program to be the waitlist control group after 3 months to 6months, with assessments conducted at 6 months (T4). | Behavioural | Active control group |
Primary outcome
6-Minute Walk Test
Time frame: T0-baseline
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
6-Minute Walk Test
Time frame: T1(1 month later)
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
6-Minute Walk Test
Time frame: T2(2 month later)
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
6-Minute Walk Test
Time frame: T3(3 month later)
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
6-Minute Walk Test
Time frame: T4(6 month later)
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
Adherence
Time frame: T0-baseline
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Adherence
Time frame: T1(1 month later)
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Adherence
Time frame: T2(2 month later)
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Adherence
Time frame: T3(3 month later)
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Adherence
Time frame: T4(6 month later)
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
The Chinese Version of the Sport Motivation Scale-II
Time frame: T0-baseline
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
The Chinese Version of the Sport Motivation Scale-II
Time frame: T1(1 month later)
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
The Chinese Version of the Sport Motivation Scale-II
Time frame: T2(2 month later)
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
The Chinese Version of the Sport Motivation Scale-II
Time frame: T3(3 month later)
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
The Chinese Version of the Sport Motivation Scale-II
Time frame: T4(6 month later)
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
The mHealth App usability questionnaire
Time frame: T0-baseline
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
The mHealth App usability questionnaire
Time frame: T1(1 month later)
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
The mHealth App usability questionnaire
Time frame: T2(2 month later)
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
The mHealth App usability questionnaire
Time frame: T3(3 month later)
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
The mHealth App usability questionnaire
Time frame: T4(6 month later)
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
50 secondary outcomes
The Pittsburgh Sleep Quality Index
Time frame: T0-baseline
The Beck Depression Inventory-II
Time frame: T0-baseline
The Rivermead Post-Concussion Symptoms Questionnaire
Time frame: T0(baseline)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time frame: T0( baseline)
The World Health Organization Quality of Life Scale-brief
Time frame: T0( baseline)
Advanced sleep pattern
Time frame: T0(baseline)
Mini-Mental State Examination
Time frame: T0( baseline)
Montreal Cognitive Assessment
Time frame: T0(baseline)
Near-Infrared Brain Blood Flow Imaging
Time frame: T0( baseline)
Semi-Structured Interviews
Time frame: T0(baseline)
The Pittsburgh Sleep Quality Index
Time frame: T1(1 month later)
The Pittsburgh Sleep Quality Index
Time frame: T2(2 month later)
The Pittsburgh Sleep Quality Index
Time frame: T3(3 month later)
The Pittsburgh Sleep Quality Index
Time frame: T4(6 month later)
The Beck Depression Inventory-II
Time frame: T1(1 month later)
The Beck Depression Inventory-II
Time frame: T2(2 month later)
The Beck Depression Inventory-II
Time frame: T3(3 month later)
The Beck Depression Inventory-II
Time frame: T4(6 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
Time frame: T1(1 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
Time frame: T2(2 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
Time frame: T3(3 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
Time frame: T4(6 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time frame: T1(1 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time frame: T2(2 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time frame: T3(3 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time frame: T4(6 month later)
The World Health Organization Quality of Life Scale-brief
Time frame: T1(1 month later)
The World Health Organization Quality of Life Scale-brief
Time frame: T2(2 month later)
The World Health Organization Quality of Life Scale-brief
Time frame: T3(3 month later)
The World Health Organization Quality of Life Scale-brief
Time frame: T4(6 month later)
Mini-Mental State Examination
Time frame: T1(1 month later)
Mini-Mental State Examination
Time frame: T2(2 month later)
Mini-Mental State Examination
Time frame: T3(3 month later)
Mini-Mental State Examination
Time frame: T4(6 month later)
Montreal Cognitive Assessment
Time frame: T1(1 month later)
Montreal Cognitive Assessment
Time frame: T2(2 month later)
Montreal Cognitive Assessment
Time frame: T3(3 month later)
Montreal Cognitive Assessment
Time frame: T4(6 month later)
Near-Infrared Brain Blood Flow Imaging
Time frame: T1(1 month later)
Near-Infrared Brain Blood Flow Imaging
Time frame: T2(2 month later)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-PEF in people with Tramatic Brain Injury, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Hsun Chiang, Professor (886-2-87923100 ext. 18761, sheisvivian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walk Test (time frame: T0-baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.