- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06362512
Cognitive-motor Exercise for Stroke Patients in Function, Cognition and Related Brain Changes. (COGMOTION)
An Innovative Cognitive-motor Exercise Training (COGMOTION) for People With Stroke: Effects on Balance, Mobility, Falls, Cognition and Related Brain Changes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marco Yiu Chung PANG, PhD
- Phone Number: 2766-7156 +852 2766-7156
- Email: Marco.Pang@polyu.edu.hk
Study Locations
-
-
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Hong Kong, China, 000000
- Recruiting
- The Hong Kong Polytechnic University
-
Contact:
- Marco Yiu Chung Pang, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Clinical diagnosis of stroke, Stroke onset of more than 6 months Aged 50 or more Capable of following verbal instructions Having a Montreal Cognitive Assessment score≥22, Able to walk for 1 minute without physical assistance Not receiving any formal rehabilitation training
Exclusion Criteria:
Contraindications to exercise (e.g., unstable angina) Contraindications to MRI (e.g., pacemaker) Color blindness Neurological disorders Gait-precluding pain Comorbidity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: dual-task group
patients receive three dual motor-cognitive exercise training per week for six weeks.
|
participants receive three 60-minute COGMOTION dual-task exercise sessions per week for six consecutive weeks.
|
Active Comparator: single-task group
Patients receive three separate cognitive and mobility exercises per week for six weeks.
|
participants receive 30-minute single motor tasks with 30-minute single cognitive tasks three times per week for six consecutive weeks.The cognitive and mobility exercises will be the same as those in the dual-task group, but they will be performed separately.
|
Active Comparator: control group
Patients receive three upper limb muscle strengthening exercise with muscle stretching per week for six weeks.
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participants receive upper limb strengthening exercise for 30 minutes and flexibility exercises for 30 minutes three times per week for six consecutive weeks.
The training is performed in sitting or standing position and no cognitive load will be added.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dual-task step frequency
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
step frequency under dual-task condition will be recorded
|
before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Dual-task cognitive performance accuracy
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Number of correct responses will be measured during dual-task conditions
|
before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood oxygenation level changes of the brain
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Blood oxygenation level changes will be measured using Magnetic Resonance Imaging during dual-task conditions
|
before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Single-task walking speed
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
10-meter walking test will be used to assess single-task walking speed in meters per second
|
before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Dual-task walking performance
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
1 min Forward Walking with Serial 3 subtractions will be used to assess motor and cognitive performance during dual-task walking.
|
before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Fall incidence
Time Frame: before the initiation of training, 6 months after training
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Monthly telephone interviews for recording fall incidence
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before the initiation of training, 6 months after training
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Mini Balance Evaluation Systems Test
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Mini Balance Evaluation Systems Test will be used to assess postural control and balance, with total points from 0-28.
Higher points indicate better performance.
|
before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Activities-specific Balance Confidence Scale
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Activities-specific Balance Confidence Scale will be used to assess confidence of functional balance performance, with total points from 0-100.
Higher points indicate better performance.
|
before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Trail Making Test
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Trail Making Test will be used to assess executive function
|
before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Digit Span Test
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Digit Span Test will be used to assess working memory
|
before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
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Montreal Cognitive Assessment
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Montreal Cognitive Assessment will be used to assess global cognition, with total points from 0-30.
Higher points indicate better performance.
|
before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Dual-task ankle movement degree
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Ankle movement degree under dual-task condition will be recorded
|
before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Dual-task cognitive performance time
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Time of correct responses under dual-task condition will be measured during dual-task conditions
|
before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Marco_PANG_2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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