StrokeCOGMOTIONNCT06362512
Cognitive-motor Exercise for Stroke Patients in Function, Cognition and Related Brain Changes.
A study testing Dual-task training, Single-task training and Upper limb strengthening exercise in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The purpose of this study is to evaluate a cognitive-motor exercise on dual-task interference during dual-task ankle movement and the corresponding alterations of brain activity. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Dual-task training, Single-task training and Upper limb strengthening exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2024to Apr 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Having a Fugl-Meyer Ankle dorsiflexion-standing position score≥1
Who cannot join
- Contraindications to exercise (e.g., unstable angina) Contraindications to MRI (e.g., pacemaker) Color blindness Neurological disorders Gait-precluding pain Comorbidity
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong, 000000
Marco Yiu Chung Pang, PhD
About this study
Official title: An Innovative Cognitive-motor Exercise Training (COGMOTION) for People With Stroke: Effects on Balance, Mobility, Falls, Cognition and Related Brain Changes.
The purpose of this study is to evaluate a cognitive-motor exercise on dual-task interference during dual-task ankle movement and the corresponding alterations of brain activity.
Read the detailed description
The prevalence rate of stroke increased by 106.0% (93.7-118.8) from 1990 to 2019 in China, and stroke burden is still severe. Community ambulation is an important factor that influences health-related quality of life after a stroke.In daily living, effective community ambulation requires the ability to maintain balance and walking function while engaging in other tasks that demand attentional resources simultaneously (i.e., dual-tasking). Increasing evidence has shown that stroke patients have more problems with dual-task balance and walking function than their age-matched able-bodied peers. stroke individuals were found to have more reduction in both the walking speed and cognitive recall than control group during walking with remembering a shopping list. Hence, since stroke victims must reintegrate into community, this kind of cognitive-motor interference needs to be thoroughly studied.
- Conditions
- Stroke
- Being tested
- Dual-task training, Single-task training, Upper limb strengthening exercise
- Keywords
- Dual-task training, Cognitive-motor interference
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-task trainingBehavioural
participants receive three 60-minute COGMOTION dual-task exercise sessions per week for six consecutive weeks.
Single-task trainingBehavioural
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.
Upper limb strengthening exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| dual-task group | Experimental | patients receive three dual motor-cognitive exercise training per week for six weeks. Receives: Behavioral: Dual-task training |
| single-task group | Active comparator | Patients receive three separate cognitive and mobility exercises per week for six weeks. Receives: Behavioral: Single-task training |
| control group | Active comparator | Patients receive three upper limb muscle strengthening exercise with muscle stretching per week for six weeks. Receives: Behavioral: Upper limb strengthening exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-task step frequency
step frequency under dual-task condition will be recorded
Measured: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Dual-task cognitive performance accuracy
Number of correct responses will be measured during dual-task conditions
Measured: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Secondary outcomes (4)
Blood oxygenation level changes of the brain
Blood oxygenation level changes will be measured using Magnetic Resonance Imaging during dual-task conditions
Measured: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Dual-task No.steps
No.steps under dual-task condition will be recorded
Measured: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Dual-task correct reaction time
Correct reaction time under dual-task condition will be recorded
Measured: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Dual-task amplitude of ankle movement
Amplitude of ankle movement under dual-task condition will be recorded
Measured: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start17 Jun 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
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
- Model description
- After stratification according to gender and walking speed, the participants will be randomly allocated to one of three groups: (1) dual-task training, (2) single-task training, and (3) control intervention, using a 1:1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362512
- Sponsor's protocol ID
- Marco_PANG_2024
- Acronym
- COGMOTION
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data can be provided via contacting the Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Cognitive-motor Exercise Training (COGMOTION) for People With Stroke: Effects on Balance, Mobility, Falls, Cognition and Related Brain Changes.
- ClinicalTrials.gov ID
- NCT06362512
- Acronym / sponsor ID
- COGMOTION / Marco_PANG_2024
- Conditions
- Stroke
- Keywords
- Dual-task training, Cognitive-motor interference
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 12 Apr 2024 (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 evaluate a cognitive-motor exercise on dual-task interference during dual-task ankle movement and the corresponding alterations of brain activity.
Detailed description
The prevalence rate of stroke increased by 106.0% (93.7-118.8) from 1990 to 2019 in China, and stroke burden is still severe. Community ambulation is an important factor that influences health-related quality of life after a stroke.In daily living, effective community ambulation requires the ability to maintain balance and walking function while engaging in other tasks that demand attentional resources simultaneously (i.e., dual-tasking). Increasing evidence has shown that stroke patients have more problems with dual-task balance and walking function than their age-matched able-bodied peers. stroke individuals were found to have more reduction in both the walking speed and cognitive recall than control group during walking with remembering a shopping list. Hence, since stroke victims must reintegrate into community, this kind of cognitive-motor interference needs to be thoroughly studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- After stratification according to gender and walking speed, the participants will be randomly allocated to one of three groups: (1) dual-task training, (2) single-task training, and (3) control intervention, using a 1:1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| dual-task group | Experimental | Behavioral: Dual-task trainingpatients receive three dual motor-cognitive exercise training per week for six weeks. |
| single-task group | Active comparator | Behavioral: Single-task trainingPatients receive three separate cognitive and mobility exercises per week for six weeks. |
| control group | Active comparator | Behavioral: Upper limb strengthening exercisePatients receive three upper limb muscle strengthening exercise with muscle stretching per week for six weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 Having a Fugl-Meyer Ankle dorsiflexion-standing position score≥1
Key exclusion criteria (1 listed)
- Contraindications to exercise (e.g., unstable angina) Contraindications to MRI (e.g., pacemaker) Color blindness Neurological disorders Gait-precluding pain Comorbidity
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 |
|---|---|---|
| Dual-task trainingparticipants receive three 60-minute COGMOTION dual-task exercise sessions per week for six consecutive weeks. | Behavioural | dual-task group |
| Single-task trainingparticipants 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. | Behavioural | single-task group |
| Upper limb strengthening exerciseparticipants 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. | Behavioural | control group |
Primary outcome
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
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
4 secondary outcomes
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
Dual-task No.steps
Time frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Dual-task correct reaction time
Time frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Dual-task amplitude of ankle movement
Time frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: Yes. The study data can be provided via contacting the Principal Investigator
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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 Dual-task training, Single-task training and Upper limb strengthening exercise in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in China.
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 1 inclusion and 1 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 5 Jul 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 China. 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 Marco Yiu Chung PANG, PhD (+852 2766-7156 ext. 2766-7156, Marco.Pang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-task step frequency (time frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training). 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 5 Jul 2024.