StrokeNCT06000644
Effects of Combined Cognitive Training and Rhythmic Auditory Stimulation in Treadmill Training After Stroke
A study testing Combined group, Cognitive group and Rhythmic group in people with Stroke, run by Chang Gung University at 1 site in Taiwan.
Trial summary
The objective of this study is to compare the effects of progressive combined cognitive training and rhythmic auditory stimulation to treadmill training (combined group), cognitive treadmill training (cognitive group), rhythmic auditory stimulation to treadmill training (rhythmic group), and treadmill walking alone… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Combined group, Cognitive group and Rhythmic group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Aug 2023to 23 Feb 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with first-time stroke;
- more than 6 months after stroke onset;
- able to walk 10 meters;
- no severe vision, hearing, or speech impairments;
- understand and follow the instructions and sign the Informed Consent Form;
- older than 20 years old.
Who cannot join
- orthopedic problems affecting walking or other diseases that may interfere with study participation;
- a score of less than 24 on the mini-mental state examination (MMSE);
- severe balance disorder with a total score of less than 45 points Berg Balance Scale.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Progressive Combined Cognitive Training and Rhythmic Auditory Stimulation in Treadmill Training on Walking Automaticity, Executive Function, and Dual-task Coordination for Patients With Chronic Stroke
The objective of this study is to compare the effects of progressive combined cognitive training and rhythmic auditory stimulation to treadmill training (combined group), cognitive treadmill training (cognitive group), rhythmic auditory stimulation to treadmill training (rhythmic group), and treadmill walking alone (treadmill group) on walking automaticity, executive function, and dual-task coordination for patients with chronic stroke (Aim 1). The second aim of this study is to investigate the factors affecting the results of interventions (Aim 2). The third aim of the study is to examine the characteristics of stroke population who are appropriate for progressive combined cognitive training and rhythmic auditory stimulation to treadmill training.
Read the detailed description
A single-blinded, randomized controlled trial will be conducted at medical centers. Eighty stroke patients will be randomized to one of the four groups. All groups will receive interventions 30 minutes per time, 3 times a week, for 4 weeks. The combined group will undertake progressive treadmill walking speed and rhythmic auditory stimulation while performing a cognitive task. The cognitive group will receive cognitive training while walking on the treadmill. The rhythmic group will hear rhythmic auditory stimulation while treadmill walking. The treadmill group will train only in progressive treadmill walking. A blinded assessor will administer three assessments. All participants will be examined for gait and cognitive performance under single-task (walking only, Stroop task only) and dual-task conditions (walking while performing the Stroop task) at baseline, post-intervention, and one-month follow-up. The primary outcome measures of gait and cognition are gait speed and cognitive score of the Stroop task under single- and dual-task conditions. The secondary outcome measures are the Mini-BESTest, Walking Ability Questionnaire, 6-minute Walk Test, and Stroke Impact Scale. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up between and within the groups.
- Conditions
- Stroke
- Being tested
- Combined group, Cognitive group, Rhythmic group, Treadmill group
- Keywords
- stroke, gait rehabilitation, rhythmic auditory stimulation, cognitive training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined groupDevice
The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing for 30 minutes per session, 3 times a week for 4 weeks.
Cognitive groupDevice
The cognitive group will receive cognitive training while treadmill walking with a progressive speed for 30 minutes per session, 3 times a week for 4 weeks .
Rhythmic groupDevice
The rhythmic group will hear rhythmic auditory stimulation while treadmill walking for 30 minutes per session, 3 times a week for 4 weeks.
Treadmill groupDevice
The treadmill group will train only in progressive treadmill walking for 30 minutes per session, 3 times a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| combined group | Experimental | The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing. Receives: Device: Combined group |
| cognitive group | Active comparator | The cognitive group will receive cognitive training while walking on the treadmill. Receives: Device: Cognitive group |
| rhythmic group | Active comparator | The rhythmic group will hear rhythmic auditory stimulation while treadmill walking. Receives: Device: Rhythmic group |
| treadmill group | Active comparator | The treadmill group will train only in progressive treadmill walking. Receives: Device: Treadmill group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed (m/s)
Participants will walk 10 meters at their preferred speed with and without the Stroop task twice, respectively. The spatiotemporal gait parameters will be examined using Physilog® sensors (Gait Up, Switzerland) and analyzed by the Gait Analysis Package software on the USB key. Walking speed (m/s) is the mean speed of forward walking, calculated in meters per second.
Measured: 5 minutes
Stride time variability (%)
The stride time is the duration of one cycle (from heel strike to heel strike of the same side). Stride time variability (%) is the coefficient of variation of stride time or cycle duration in percent.
Measured: 5 minutes
Gait asymmetry (%)
Gait asymmetry will be assessed by comparing left and right swing time, in percent. A perfect symmetry outputs a value of 0%.
Measured: 5 minutes
Cognitive composite score
The Stroop task is the commonly utilized dual-task paradigm and measures executive function and response inhibition, which plays a vital role during walking. Therefore, the Stroop task will be selected to assess cognitive dual-task walking. The Stroop task will be performed while sitting and walking to assess executive function under single-task and dual-task conditions. The following is the formula for calculating the cognitive composite score: Cognitive composite score of the Stroop task = [Accuracy(%)/Reaction time(milliseconds)] * 100. The better the cognitive performance of the Stroop task, the higher the cognitive composite score.
The instructions for the dual-task walking (walking + Stroop) are designed to encourage neutral prioritization between the two tasks ("walk at the preferred speed while performing the Stroop task as accurately and quickly as you can").
Measured: 5 minutes
Secondary outcomes (7)
Dual-task automaticity
Automaticity is based on the combined interference of both motor (i.e., walking speed) and cognitive DTE. The combined dual-task effect (cDTE) is a measure that quantifies automaticity while performing a dual-task. The walking speed and cognitive composite score under single-task and dual-task conditions will be used to calculate combined DTE.A negative cDTE value is indicative of automaticity under dual-task that deteriorated or interfered. A positive cDTE value indicates automaticity facilitation.
Measured: 5 minutes
Task-specific dual-task interference
Task-specific dual-task interference calculates the motor (i.e., walking speed) or cognitive dual-task effect (DTE), which relates dual-task performance to single-task performance. For assessing dual-task interference, quantifying the combined interference of the motor and the cognitive tasks may be a more comprehensive measure of the dual-task effect to provide a more accurate picture of gait automaticity. The walking speed and cognitive composite score will be used to calculate motor and cognitive dual-task effect (DTE). For both the motor (i.e., walking speed) and cognitive DTE in this study, negative DTE values (i.e., dual-task interfence) indicate poor performance under dual-task walking condition compared to single-task conditions.
Measured: 5 minutes
6-minute Walking test, 6MWT
The 6-minute walk test will be used to measure participants' walking capacity and walking endurance.The participants will ask to walk for six minutes at their own pace, resting or slowing down as needed, and the total distance (meters) of walking in six minutes will be recorded
Measured: 6 minutes
Stroke impact scale, SIS
The SIS was developed to measure the quality of life after a stroke. The SIS 3.0 has eight domains: strength, hand function, mobility, activities of daily living/instrumental activities of daily living (i.e., ADLs and IADLs), memory and thinking, communication, emotion, and social participation. Scores for each domain range from 0 to 100, and higher scores indicate a better health-related quality of life. Lower scores indicate more incredible difficulty in task completion during the past week or past two weeks, or past four weeks. Eight items on the social participation domain and eight items on the mobility domain of the SIS will be used to measure the social participation of individuals with chronic stroke in this study.
Measured: 10 minutes
Mini-Balance Evaluation System Test, Mini-BESTest
The Mini-BESTest is a reliable and valid tool for evaluating balance in people with chronic stroke. It consists of 14 items and includes four subscales: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each test item is rated on a three-point ordinal scale (0-2, 0=severe, 1=moderate, and 2=normal), with the total score ranging between 0 and 28 points.
Measured: 10 minutes
Walking ability questionnaire
The walking ability questionnaire was designed to provide a more detailed assessment of the individual's social limitations due to reduced walking ability. A research assistant will administer the questionnaire to rate the participant's current customary mobility of 19 ambulatory activities performed in the home (8 items) and community (11 items). Current customary mobility was defined as an individual's self-reported ability to enter and leave the listed locations. Each test item is rated on a five-point ordinal scale (0-4, 0= unable, 1= wheelchair, 2="assisted, 3= supervised, 4= independent). An overall score was calculated. The range of scale was 0 to 76.
Measured: 5 minutes
Outdoor walking assessment
Participants will walk 400 meters at their comfortable speed on the street. A 402-meter walkway will be used for outdoor walking test. In order to allow the participants to have enough distance to accelerate and decelerate, only the time taken the middle 400 meters will be recorded by a stopwatch. The outcome measure will be walking speed (m/s).
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start30 Aug 2023
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Ling Chuang, Chang Gung University
- Investigators
- Li-Ling Chuang, Ph.D., Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000644
- Sponsor's protocol ID
- CMRPD1M0841
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2023
- Last updated
- 19 Mar 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Combined Cognitive Training and Rhythmic Auditory Stimulation in Treadmill Training on Walking Automaticity, Executive Function, and Dual-task Coordination for Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT06000644
- Acronym / sponsor ID
- CMRPD1M0841
- Conditions
- Stroke
- Keywords
- stroke, gait rehabilitation, rhythmic auditory stimulation, cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 21 Aug 2023 (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 objective of this study is to compare the effects of progressive combined cognitive training and rhythmic auditory stimulation to treadmill training (combined group), cognitive treadmill training (cognitive group), rhythmic auditory stimulation to treadmill training (rhythmic group), and treadmill walking alone (treadmill group) on walking automaticity, executive function, and dual-task coordination for patients with chronic stroke (Aim 1). The second aim of this study is to investigate the factors affecting the results of interventions (Aim 2). The third aim of the study is to examine the characteristics of stroke population who are appropriate for progressive combined cognitive training and rhythmic auditory stimulation to treadmill training.
Detailed description
A single-blinded, randomized controlled trial will be conducted at medical centers. Eighty stroke patients will be randomized to one of the four groups. All groups will receive interventions 30 minutes per time, 3 times a week, for 4 weeks. The combined group will undertake progressive treadmill walking speed and rhythmic auditory stimulation while performing a cognitive task. The cognitive group will receive cognitive training while walking on the treadmill. The rhythmic group will hear rhythmic auditory stimulation while treadmill walking. The treadmill group will train only in progressive treadmill walking. A blinded assessor will administer three assessments. All participants will be examined for gait and cognitive performance under single-task (walking only, Stroop task only) and dual-task conditions (walking while performing the Stroop task) at baseline, post-intervention, and one-month follow-up. The primary outcome measures of gait and cognition are gait speed and cognitive score of the Stroop task under single- and dual-task conditions. The secondary outcome measures are the Mini-BESTest, Walking Ability Questionnaire, 6-minute Walk Test, and Stroke Impact Scale. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up between and within the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| combined group | Experimental | Device: Combined groupThe combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing. |
| cognitive group | Active comparator | Device: Cognitive groupThe cognitive group will receive cognitive training while walking on the treadmill. |
| rhythmic group | Active comparator | Device: Rhythmic groupThe rhythmic group will hear rhythmic auditory stimulation while treadmill walking. |
| treadmill group | Active comparator | Device: Treadmill groupThe treadmill group will train only in progressive treadmill walking. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosed with first-time stroke;
- more than 6 months after stroke onset;
- able to walk 10 meters;
- no severe vision, hearing, or speech impairments;
- understand and follow the instructions and sign the Informed Consent Form;
Key exclusion criteria (3 listed)
- orthopedic problems affecting walking or other diseases that may interfere with study participation;
- a score of less than 24 on the mini-mental state examination (MMSE);
- severe balance disorder with a total score of less than 45 points Berg Balance Scale.
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 |
|---|---|---|
| Combined groupThe combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing for 30 minutes per session, 3 times a week for 4 weeks. | Device | combined group |
| Cognitive groupThe cognitive group will receive cognitive training while treadmill walking with a progressive speed for 30 minutes per session, 3 times a week for 4 weeks . | Device | cognitive group |
| Rhythmic groupThe rhythmic group will hear rhythmic auditory stimulation while treadmill walking for 30 minutes per session, 3 times a week for 4 weeks. | Device | rhythmic group |
| Treadmill groupThe treadmill group will train only in progressive treadmill walking for 30 minutes per session, 3 times a week for 4 weeks. | Device | treadmill group |
Primary outcome
Walking speed (m/s)
Time frame: 5 minutes
Participants will walk 10 meters at their preferred speed with and without the Stroop task twice, respectively. The spatiotemporal gait parameters will be examined using Physilog® sensors (Gait Up, Switzerland) and analyzed by the Gait Analysis Package software on the USB key. Walking speed (m/s) is the mean speed of forward walking, calculated in meters per second.
Stride time variability (%)
Time frame: 5 minutes
The stride time is the duration of one cycle (from heel strike to heel strike of the same side). Stride time variability (%) is the coefficient of variation of stride time or cycle duration in percent.
Gait asymmetry (%)
Time frame: 5 minutes
Gait asymmetry will be assessed by comparing left and right swing time, in percent. A perfect symmetry outputs a value of 0%.
Cognitive composite score
Time frame: 5 minutes
The Stroop task is the commonly utilized dual-task paradigm and measures executive function and response inhibition, which plays a vital role during walking. Therefore, the Stroop task will be selected to assess cognitive dual-task walking. The Stroop task will be performed while sitting and walking to assess executive function under single-task and dual-task conditions. The following is the formula for calculating the cognitive composite score: Cognitive composite score of the Stroop task = [Accuracy(%)/Reaction time(milliseconds)] * 100. The better the cognitive performance of the Stroop task, the higher the cognitive composite score. The instructions for the dual-task walking (walking + Stroop) are designed to encourage neutral prioritization between the two tasks ("walk at the preferred speed while performing the Stroop task as accurately and quickly as you can").
7 secondary outcomes
Dual-task automaticity
Time frame: 5 minutes
Task-specific dual-task interference
Time frame: 5 minutes
6-minute Walking test, 6MWT
Time frame: 6 minutes
Stroke impact scale, SIS
Time frame: 10 minutes
Mini-Balance Evaluation System Test, Mini-BESTest
Time frame: 10 minutes
Walking ability questionnaire
Time frame: 5 minutes
Outdoor walking assessment
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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. This study is not recruiting at the moment.
Li-Ling Chuang, Ph.D. principal investigator
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined group, Cognitive group and Rhythmic group in people with Stroke, run by Chang Gung 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 19 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking speed (m/s) (time frame: 5 minutes). The study lists 4 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 19 Mar 2026.