StrokeNCT04328779
Multi-task Gait Training Mode to Enhance Walking Function in Patients With Chronic Stroke
A study testing The multi-task overground walking training, The multi-task treadmill walking training and Traditional rehabilitation in people with Stroke, run by Chang Gung University at 1 site in Taiwan.
Trial summary
The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of multi-task walking interventions on walking for patients with chronic stroke. Specifically, we will investigate psychometric properties (i.e. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- The multi-task overground walking training, The multi-task treadmill walking training and Traditional rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Aug 2020to 31 Oct 2023
- 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
- first-ever stroke with onset duration more than 3 months
- able to walk 10 m
- no severe vision, hearing, and language problems.
Who cannot join
- orthopedic and other neurological disorders that affect walking
- other treatments that could influence the effects of the interventions (e.g., recent Botulin toxin treatment of the lower extremity)
- moderate or severe cognitive impairments (score < 24 on Mini-Mental State Examination)
- severe uncorrected visual deficits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-task Gait Training Mode to Enhance Walking Function, Cognitive Performance, Task Coordination, and Transfer to Community Ambulation in Patients With Chronic Stroke
The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of multi-task walking interventions on walking for patients with chronic stroke. Specifically, we will investigate psychometric properties (i.e. reliability, validity, and responsiveness) of dual-task walking assessments with the Stroop task for chronic stroke individuals (Aim 1). The second aim of this study is to compare the effects of multi-task walking training mode to traditional rehabilitation in patients with chronic stroke (Aim 2). The third aim of this study is to compare the immediate, retained, and transfer effect of multi-task overground walking training to multi-task treadmill walking training on walking function, cognitive performance, task coordination, and community ambulation in patients with chronic stroke (Aim 3).
Read the detailed description
Only 7% patients can walk safely in the community. Functional community ambulation requires the ability of walking while performing other tasks. It is emergent to establish dual-task walking assessment with good psychometric properties and to identify the most effective approach that enhances dual-task walking performance for stroke patients. Our ongoing study found that motor tasks combined with cognitive dual-task training (multi-tasking ) have more improvements on cognitive performance of the Stroop task while walking than cognitive dual-task training alone. Therefore, combined motor and cognitive elements to walking training might be considered as a novel therapeutic strategy to promote functional ambulation and recovery of stroke patients. This combined strategy is based on attentional capacity sharing theory and the research advances on dual-task to enhance active participation and cognitive involvement, strengthen dual-task walking ability, then transfer to promote community ambulation and participation. However, lacking prospective, controlled trials quantify gait and cognition under dual-task conditions after multi-task walking training. Specifically, we will investigate psychometric properties of dual-task walking assessments for chronic stroke individuals. The second aim is to compare the immediate, retained, and transfer effects of of multi-task overground walking training to multi-task treadmill walking and traditional rehabilitation on walking function, cognitive performance, task coordination, and community ambulation in patients with chronic stroke. A metric analysis and comparative efficacy research will be conducted. Sixty chronic stroke patients will receive dual-task walking assessments twice at pretreatment with a 1-week interval for test-retest assessment and investigation of the reliability and validity of outcome measures. The primary outcome measure of the dual-task walking assessments will include walking at preferred speed and fast speed and simultaneously perform the Stroop task. Concurrent validity will be studied to validate the dual-task walking measures with each other and with the item 14 of the mini-Balance Evaluation Systems test (Mini-BESTest), dual-task Timed-up-and-Go test (dual-TUG), and 6-min walk test obtain concurrently for assessing dual-task ability. In addition, we will compare dual-task walking performance between fallers and non-fallers to examine discriminant validity of dual-task walking assessments. A comparative efficacy research is a single-blind, randomized controlled trial, which will be conducted at medical centers. Sixty ambulatory stroke patients will be randomized to multi-task overground walking training or multi-task treadmill walking training or traditional rehabilitation. All three groups will receive interventions 3 times a week for 4 weeks. The multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks. The multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill. Traditional rehabilitation will train strength, balance, and gait. A blinded assessor will administer three assessments All participants will be examined gait and cognitive performance under single-task (walking only, cognitive tasks only) and dual-task conditions (walking while performing the Stroop task) at baseline, post intervention, and 1-month follow-up. The primary outcome measure of gait and cognition is gait speed and composite score of accuracy and reaction time of the cognitive tasks under single- and dual-task conditions. The secondary outcome measures will be the Mini-BESTest, single- and dual-TUG, Functional Gait Assessment, 6-minute Walk Test, physical activity monitor, and Stroke Impact Scale. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up among the groups.
- Conditions
- Stroke
- Being tested
- The multi-task overground walking training, The multi-task treadmill walking training, Traditional rehabilitation
- Keywords
- multi-task training, community ambulation, cognition
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The multi-task overground walking trainingOther
The multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks for 30 minutes per session, 3 times a week for 4 weeks.
The multi-task treadmill walking trainingDevice
The multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill for 30 minutes per session, 3 times a week for 4 weeks.
Traditional rehabilitationOther
Traditional rehabilitation will train strength, balance, and gait for 30 minutes per session, 3 times a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| multi-task overground walking training | Experimental | The multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks. Receives: Other: The multi-task overground walking training |
| multi-task treadmill walking | Active comparator | The multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill. Receives: Device: The multi-task treadmill walking training |
| traditional rehabilitation | Active comparator | Traditional rehabilitation group will train strength, balance, and gait. Receives: Other: Traditional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait speed
Participants will walk 10m at their preferred speed and at fast speed. A 12-meter walkway will be used for walking testing. In order to allow the subjects to have enough distance to accelerate and decelerate, only the time taken to walk the middle 10 meters will be recorded by a stopwatch or Physilog® sensors (Gait Up, Switzerland). The primary gait parameter is gait speed (cm/s) under single-task and dual-task walking conditions using the 10 Meter Walking Test.
Measured: 5 minutes
composite score
For the Stroop task, we will calculate the composite score for the Stroop task under single-task and dual-task walking conditions by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds), which accounts for speed-accuracy tradeoffs.
Measured: 5 minutes
Secondary outcomes (8)
Mini-Balance Evaluation Systems Test (Mini-BESTest)
The Mini-BESTest consists of 14 items and.includes four subscales: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is rated on a three-point ordinal scale (0 = severe, 1=moderate, and 2 = normal), with a maximum score of 28 points.
Measured: 10 minutes
Timed Up and Go Test (TUG)
The TUG test will be used as an index of dynamic balance of the elderly and stroke patients. At the signal, participants stand up, walk 3 m, turn, walk back, and sit down again. The score is the time to complete the test measured using a stopwatch. The TUG test will be administered under the single-task (preferred speed and maximum fast) and dual-task conditions (tray carrying and counting backward by 3s). In dual-task condition, participants will be asked to perform the TUG test while carrying a tray with glasses (dual-TUG manual) or counting backward by 3s (dual-TUG cognition). The instruction for dual-TUG tests is to walk with your comfortable speed and concurrently perform a secondary task (carry the tray in front of you with both hands without dropping glasses on the tray or counting backward by 3s).
Measured: 2 minutes
Functional Gait Assessment (FGA)
The FGA is comprised of 10-item that contains 7 of 8 items (except walking around obstacles) from the Dynamic Gait Index and 3 additional tasks, including walking with a narrow base of support, walking with the eyes closed, and walking backward. Subjects' performance of each test item was rated on a 4-point scale (0-3), with the total score ranging between 0 and 30.
Measured: 10 minutes
Berg Balance Scale (BBS)
The BBS is a 14-item scale quantitatively assesses both static and dynamic balance with psychometrically sound measure of balance impairment after stroke. The items are scored from 0 to 4, with a score of 0 representing independent item completion. Scores of the BBS range from 0 to 56, with higher scores suggest better balance.
Measured: 5-10 minutes
6-minute Walk Test
Participants walk for 6-minute at comfortable speed to examine their walking endurance.
Measured: 6 minutes
Physical activity monitor
Physical activity monitor will be examined by StepWatch TM Activity Monitor (Modus Health, Washington, DC) to objectively measure total walking step numbers of continually three days (except for sleep and bath).
Measured: 3 days
Stroke Impact Scale Version 3.0 (SIS 3.0)
Health-related quality of life will be measured using the SIS 3.0, which is specific to the stroke population. The SIS 3.0 contains 59 items measuring 8 domains (i.e., strength, hand function, Activities of Daily Living/Instrumental Activities of Daily Living [ADL/IADL], mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week. Aggregate scores, ranges from 0 to 100, are generated for each domain.
Measured: 10 minutes
Patient Global Impression of Change Scale (PGIC)
Participants will be evaluated regarding the participants' perception with the change in walking related to the intervention. The PGIC is a transition scale that is a single question asking the patients to rate their walking function now, as compared with how it was prior to before beginning treatment on a scale from 1 (very much better ) to 7 (very much worse).
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start14 Aug 2020
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
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
- 68 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
- NCT04328779
- Sponsor's protocol ID
- ChangGungU
- Status last verified
- Feb 2024
- First submitted
- 30 Mar 2020
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-task Gait Training Mode to Enhance Walking Function, Cognitive Performance, Task Coordination, and Transfer to Community Ambulation in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT04328779
- Acronym / sponsor ID
- ChangGungU
- Conditions
- Stroke
- Keywords
- multi-task training, community ambulation, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 31 Mar 2020 (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 investigate psychometric properties of dual-task walking assessments and compare effects of multi-task walking interventions on walking for patients with chronic stroke. Specifically, we will investigate psychometric properties (i.e. reliability, validity, and responsiveness) of dual-task walking assessments with the Stroop task for chronic stroke individuals (Aim 1). The second aim of this study is to compare the effects of multi-task walking training mode to traditional rehabilitation in patients with chronic stroke (Aim 2). The third aim of this study is to compare the immediate, retained, and transfer effect of multi-task overground walking training to multi-task treadmill walking training on walking function, cognitive performance, task coordination, and community ambulation in patients with chronic stroke (Aim 3).
Detailed description
Only 7% patients can walk safely in the community. Functional community ambulation requires the ability of walking while performing other tasks. It is emergent to establish dual-task walking assessment with good psychometric properties and to identify the most effective approach that enhances dual-task walking performance for stroke patients. Our ongoing study found that motor tasks combined with cognitive dual-task training (multi-tasking ) have more improvements on cognitive performance of the Stroop task while walking than cognitive dual-task training alone. Therefore, combined motor and cognitive elements to walking training might be considered as a novel therapeutic strategy to promote functional ambulation and recovery of stroke patients. This combined strategy is based on attentional capacity sharing theory and the research advances on dual-task to enhance active participation and cognitive involvement, strengthen dual-task walking ability, then transfer to promote community ambulation and participation. However, lacking prospective, controlled trials quantify gait and cognition under dual-task conditions after multi-task walking training. Specifically, we will investigate psychometric properties of dual-task walking assessments for chronic stroke individuals. The second aim is to compare the immediate, retained, and transfer effects of of multi-task overground walking training to multi-task treadmill walking and traditional rehabilitation on walking function, cognitive performance, task coordination, and community ambulation in patients with chronic stroke. A metric analysis and comparative efficacy research will be conducted. Sixty chronic stroke patients will receive dual-task walking assessments twice at pretreatment with a 1-week interval for test-retest assessment and investigation of the reliability and validity of outcome measures. The primary outcome measure of the dual-task walking assessments will include walking at preferred speed and fast speed and simultaneously perform the Stroop task. Concurrent validity will be studied to validate the dual-task walking measures with each other and with the item 14 of the mini-Balance Evaluation Systems test (Mini-BESTest), dual-task Timed-up-and-Go test (dual-TUG), and 6-min walk test obtain concurrently for assessing dual-task ability. In addition, we will compare dual-task walking performance between fallers and non-fallers to examine discriminant validity of dual-task walking assessments. A comparative efficacy research is a single-blind, randomized controlled trial, which will be conducted at medical centers. Sixty ambulatory stroke patients will be randomized to multi-task overground walking training or multi-task treadmill walking training or traditional rehabilitation. All three groups will receive interventions 3 times a week for 4 weeks. The multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks. The multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill. Traditional rehabilitation will train strength, balance, and gait. A blinded assessor will administer three assessments All participants will be examined gait and cognitive performance under single-task (walking only, cognitive tasks only) and dual-task conditions (walking while performing the Stroop task) at baseline, post intervention, and 1-month follow-up. The primary outcome measure of gait and cognition is gait speed and composite score of accuracy and reaction time of the cognitive tasks under single- and dual-task conditions. The secondary outcome measures will be the Mini-BESTest, single- and dual-TUG, Functional Gait Assessment, 6-minute Walk Test, physical activity monitor, and Stroke Impact Scale. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up among the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| multi-task overground walking training | Experimental | Other: The multi-task overground walking trainingThe multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks. |
| multi-task treadmill walking | Active comparator | Device: The multi-task treadmill walking trainingThe multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill. |
| traditional rehabilitation | Active comparator | Other: Traditional rehabilitationTraditional rehabilitation group will train strength, balance, and gait. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- first-ever stroke with onset duration more than 3 months
- able to walk 10 m
- no severe vision, hearing, and language problems.
Key exclusion criteria (4 listed)
- orthopedic and other neurological disorders that affect walking
- other treatments that could influence the effects of the interventions (e.g., recent Botulin toxin treatment of the lower extremity)
- moderate or severe cognitive impairments (score < 24 on Mini-Mental State Examination)
- severe uncorrected visual deficits.
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 |
|---|---|---|
| The multi-task overground walking trainingThe multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks for 30 minutes per session, 3 times a week for 4 weeks. | Other | multi-task overground walking training |
| The multi-task treadmill walking trainingThe multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill for 30 minutes per session, 3 times a week for 4 weeks. | Device | multi-task treadmill walking |
| Traditional rehabilitationTraditional rehabilitation will train strength, balance, and gait for 30 minutes per session, 3 times a week for 4 weeks. | Other | traditional rehabilitation |
Primary outcome
gait speed
Time frame: 5 minutes
Participants will walk 10m at their preferred speed and at fast speed. A 12-meter walkway will be used for walking testing. In order to allow the subjects to have enough distance to accelerate and decelerate, only the time taken to walk the middle 10 meters will be recorded by a stopwatch or Physilog® sensors (Gait Up, Switzerland). The primary gait parameter is gait speed (cm/s) under single-task and dual-task walking conditions using the 10 Meter Walking Test.
composite score
Time frame: 5 minutes
For the Stroop task, we will calculate the composite score for the Stroop task under single-task and dual-task walking conditions by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds), which accounts for speed-accuracy tradeoffs.
8 secondary outcomes
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time frame: 10 minutes
Timed Up and Go Test (TUG)
Time frame: 2 minutes
Functional Gait Assessment (FGA)
Time frame: 10 minutes
Berg Balance Scale (BBS)
Time frame: 5-10 minutes
6-minute Walk Test
Time frame: 6 minutes
Physical activity monitor
Time frame: 3 days
Stroke Impact Scale Version 3.0 (SIS 3.0)
Time frame: 10 minutes
Patient Global Impression of Change Scale (PGIC)
Time frame: 1 minute
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 7 Feb 2024.
- 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 The multi-task overground walking training, The multi-task treadmill walking training and Traditional rehabilitation 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 3 inclusion and 4 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 7 Feb 2024. 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?
gait speed (time frame: 5 minutes). The study lists 2 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 7 Feb 2024.