Mild Traumatic Brain InjuryNCT05638659
Elucidate the Mechanisms, Development and Effectiveness of Balance Control and Gait Strategy After Mild Traumatic Brain Injury: Develop Innovative Design of Computerized Dual-task Balance Module
A study testing Computerized dual-task balance and home program and Medical consultation and traditional balance training in people with Mild Traumatic Brain Injury, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The purpose of this study is to innovatively design and develop computerized dual-task balance training modules and home modules, and conduct proactive clinical verification to focus on the effectiveness of balance control and gait stabilization strategies. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Computerized dual-task balance and home program and Medical consultation and traditional balance training
- 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
- 16 Mar 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 20-80 years old.
- Patients with mild traumatic brain injury: According to the American Congress of Rehabilitation Medicine, the loss of consciousness is less than 30 minutes, the coma index is 13-15, and the post-traumatic amnesia is less than 24 hours.
- Healthy patients: healthy subjects without any neurological, psychiatric, or severe musculoskeletal medical history.
- Regardless of gender.
Who cannot join
- Mild traumatic brain injury: moderate to severe brain injury, epilepsy, history of cardiovascular disease, lack of intelligence, neurodegenerative diseases, history of head trauma, systemic diseases, left-handedness, and use of psychotropic drugs.
- Healthy subjects: any neurological, psychiatric, severe musculoskeletal medical history.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to innovatively design and develop computerized dual-task balance training modules and home modules, and conduct proactive clinical verification to focus on the effectiveness of balance control and gait stabilization strategies. It is expected that in addition to the development of the training module, a proactive study will be conducted at the same time. During the period from the fourth quarter of the first year to the second year, there will be 25 patients in the experimental group and 25 patients in the control group. A total of 50 patients will undergo preliminary efficacy analysis.
Read the detailed description
After mild traumatic brain injury (mTBI), patients often complain of dizziness, balance disturbances, and gait instability. On average, dizziness accounts for about 23 to 81%, and dizziness symptoms persist from 1.2% 6 months after the injury. Between 32.5% in 5 years. In the past, in the process of neuron regeneration and repair after mild traumatic brain injury, it was found that vestibular function and biomarkers may be related to balance restoration and treatment. It is necessary to conduct further research to explain its potential mechanism and clinical significance. In addition, balance training after mTBI can accelerate dizziness recovery, balance control and gait stability, but the effect lasts for a limited time. The development of a dual-task balance training module can extend the recovery time, this project needs to be discussed in depth. This project mainly explores the influence of balance control and gait strategies after mTBI, linking vestibular function and biomarkers; innovative design and development of computerized dual-task balance training and home modules; combined with computerized dual-task balance training modules can accelerate the recovery of dizziness, balance control and gait stability after injury.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Computerized dual-task balance and home program, Medical consultation and traditional balance training
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized dual-task balance and home programBehavioural
Portable force plate with aluminum top plate for measuring ground reaction forces, moments and the center of pressure in biomechanics. Through software to collect data from the force plates, converts the trials into useful information and plots the results. The force plates and charge amplifiers are fully remote controlled by software thus making the system extremely flexible and easy to use.
Medical consultation and traditional balance trainingBehavioural
Participants were assigned to read the health education flier and were assessed directly.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Twice a week for 8 weeks, total of 16 sessions course of computerized dual-task balance and home program. Receives: Behavioral: Computerized dual-task balance and home program |
| Control group | Active comparator | Medical consultation and traditional balance training, and assessed after 8 weeks. Receives: Behavioral: Medical consultation and traditional balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance test
Berg Balance Scale (BBS), which rated performance from 0 (cannot perform) to 4(normal performance) on 14 different tasks, including ability to sit, stand, reach, lean over, turn and look over each shoulder, turn in a complete circle and step. The total possible score is 56, indicating excellent balance. A score of 0 to 20 indicates a high risk, 21 40 indicates a medium risk, and 41 56 indicates a low risk of falling. indicates a low risk of falling. Balance Error Scoring System (BESS) test Balance Error Scoring System (BESS) test
Measured: The end of intervention (assessments within one week)
Balance of sensory-integration test
The balance of postural-stability test and the modified clinical test of sensory integration and balance (mCTSIB) were performed using the Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA).
Measured: The end of intervention (assessments within one week)
Balance of postural-stability test
The balance of postural stability was tested according to 3 stability indices (overall stability, OA; anterior-to-posterior stability, AP; and medial-to-lateral stability, ML).
Measured: The end of intervention (assessments within one week)
Modified clinical test of sensory integration and balance (mCTSIB)
The mCTSIB, which includes 4 sway indices, was conducted 4 sensory conditions: (1) eyes open whilst standing on a firm surface (EOFIS); (2) eyes closed whilst standing on a firm surface (ECFIS); (3) eyes open whilst standing on an unstable (foam) surface (EOFOS); and (4) eyes closed whilst standing on an unstable (foam) surface (ECFOS).
Measured: The end of intervention (assessments within one week)
Gait analysis
The spatiotemporal gait parameters of asymmetry of the feet were measured with Physilog® system (Gait up Sàrl, Lausanne, Switzerland).
Measured: The end of intervention (assessments within one week)
Vestibular function test - oculomotor system
Use smooth pursuit eye movements (SPEMs) to obtain baseline data. The examiner evaluates SPEMs by subjectively noting their accuracy in relation to a target that is being moved manually to nine directions. At the same time, the patient follows it with his or her eyes.
Measured: The end of intervention (assessments within one week)
Secondary outcomes (1)
Biomarker
Sera were assessed for for anti-bone marrow X kinase (anti-BMX, or cytoplasmic tyrosine-protein kinase) antibodies using using a commercial enzyme-linked immunosorbent assay (ELISA) kit with a range of 1.56 g/L according to the manufacturer's instructions. Results were determined by the optical density of each well, using the microplate reader Infinite 200 measured at 450 nm. A standard curve was made by reducing the data using the computer software Magellan capable of generating a four-parameter logistic (4-PL) curve-fit and calculating the sample concentrations.
Measured: The end of intervention (assessments within one week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start16 Mar 2022
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Fong Lin, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638659
- Sponsor's protocol ID
- N202201026
- Status last verified
- Nov 2022
- First submitted
- 13 Oct 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidate the Mechanisms, Development and Effectiveness of Balance Control and Gait Strategy After Mild Traumatic Brain Injury: Develop Innovative Design of Computerized Dual-task Balance Module
- ClinicalTrials.gov ID
- NCT05638659
- Acronym / sponsor ID
- N202201026
- Conditions
- Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 6 Dec 2022 (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.
The purpose of this study is to innovatively design and develop computerized dual-task balance training modules and home modules, and conduct proactive clinical verification to focus on the effectiveness of balance control and gait stabilization strategies. It is expected that in addition to the development of the training module, a proactive study will be conducted at the same time. During the period from the fourth quarter of the first year to the second year, there will be 25 patients in the experimental group and 25 patients in the control group. A total of 50 patients will undergo preliminary efficacy analysis.
Detailed description
After mild traumatic brain injury (mTBI), patients often complain of dizziness, balance disturbances, and gait instability. On average, dizziness accounts for about 23 to 81%, and dizziness symptoms persist from 1.2% 6 months after the injury. Between 32.5% in 5 years. In the past, in the process of neuron regeneration and repair after mild traumatic brain injury, it was found that vestibular function and biomarkers may be related to balance restoration and treatment. It is necessary to conduct further research to explain its potential mechanism and clinical significance. In addition, balance training after mTBI can accelerate dizziness recovery, balance control and gait stability, but the effect lasts for a limited time. The development of a dual-task balance training module can extend the recovery time, this project needs to be discussed in depth. This project mainly explores the influence of balance control and gait strategies after mTBI, linking vestibular function and biomarkers; innovative design and development of computerized dual-task balance training and home modules; combined with computerized dual-task balance training modules can accelerate the recovery of dizziness, balance control and gait stability after injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Computerized dual-task balance and home programTwice a week for 8 weeks, total of 16 sessions course of computerized dual-task balance and home program. |
| Control group | Active comparator | Behavioral: Medical consultation and traditional balance trainingMedical consultation and traditional balance training, and assessed after 8 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 20-80 years old.
- Patients with mild traumatic brain injury: According to the American Congress of Rehabilitation Medicine, the loss of consciousness is less than 30 minutes, the coma index is 13-15, and the post-traumatic amnesia is less than 24 hours.
- Healthy patients: healthy subjects without any neurological, psychiatric, or severe musculoskeletal medical history.
- Regardless of gender.
Key exclusion criteria (2 listed)
- Mild traumatic brain injury: moderate to severe brain injury, epilepsy, history of cardiovascular disease, lack of intelligence, neurodegenerative diseases, history of head trauma, systemic diseases, left-handedness, and use of psychotropic drugs.
- Healthy subjects: any neurological, psychiatric, severe musculoskeletal medical history.
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 |
|---|---|---|
| Computerized dual-task balance and home programPortable force plate with aluminum top plate for measuring ground reaction forces, moments and the center of pressure in biomechanics. Through software to collect data from the force plates, converts the trials into useful information and plots the results. The force plates and charge amplifiers are fully remote controlled by software thus making the system extremely flexible and easy to use. | Behavioural | Experimental group |
| Medical consultation and traditional balance trainingParticipants were assigned to read the health education flier and were assessed directly. | Behavioural | Control group |
Primary outcome
Balance test
Time frame: The end of intervention (assessments within one week)
Berg Balance Scale (BBS), which rated performance from 0 (cannot perform) to 4(normal performance) on 14 different tasks, including ability to sit, stand, reach, lean over, turn and look over each shoulder, turn in a complete circle and step. The total possible score is 56, indicating excellent balance. A score of 0 to 20 indicates a high risk, 21 40 indicates a medium risk, and 41 56 indicates a low risk of falling. indicates a low risk of falling. Balance Error Scoring System (BESS) test Balance Error Scoring System (BESS) test
Balance of sensory-integration test
Time frame: The end of intervention (assessments within one week)
The balance of postural-stability test and the modified clinical test of sensory integration and balance (mCTSIB) were performed using the Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA).
Balance of postural-stability test
Time frame: The end of intervention (assessments within one week)
The balance of postural stability was tested according to 3 stability indices (overall stability, OA; anterior-to-posterior stability, AP; and medial-to-lateral stability, ML).
Modified clinical test of sensory integration and balance (mCTSIB)
Time frame: The end of intervention (assessments within one week)
The mCTSIB, which includes 4 sway indices, was conducted 4 sensory conditions: (1) eyes open whilst standing on a firm surface (EOFIS); (2) eyes closed whilst standing on a firm surface (ECFIS); (3) eyes open whilst standing on an unstable (foam) surface (EOFOS); and (4) eyes closed whilst standing on an unstable (foam) surface (ECFOS).
Gait analysis
Time frame: The end of intervention (assessments within one week)
The spatiotemporal gait parameters of asymmetry of the feet were measured with Physilog® system (Gait up Sàrl, Lausanne, Switzerland).
Vestibular function test - oculomotor system
Time frame: The end of intervention (assessments within one week)
Use smooth pursuit eye movements (SPEMs) to obtain baseline data. The examiner evaluates SPEMs by subjectively noting their accuracy in relation to a target that is being moved manually to nine directions. At the same time, the patient follows it with his or her eyes.
1 secondary outcome
Biomarker
Time frame: The end of intervention (assessments within one week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized dual-task balance and home program and Medical consultation and traditional balance training in people with Mild Traumatic Brain Injury, run by Taipei Medical University 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li-Fong Lin, Ph.D. (+886-27361661 ext. 3618, fong930@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance test (time frame: The end of intervention (assessments within one week)). The study lists 6 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 6 Dec 2022.