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Cognitive-motor Exercise for Stroke Patients in Function, Cognition and Related Brain Changes.

An Innovative Cognitive-motor Exercise Training (COGMOTION) for People With Stroke: Effects on Balance, Mobility, Falls, Cognition and Related Brain Changes.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06362512
Acronym
COGMOTION
Enrollment
84
Registered
2024-04-12
Start date
2024-06-17
Completion date
2026-04-30
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Dual-task training, Cognitive-motor interference

Brief 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.

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.

Interventions

participants receive three 60-minute COGMOTION dual-task exercise sessions per week for six consecutive 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.

BEHAVIORALUpper limb strengthening exercise

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.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

This will be a single-blinded randomized controlled trial . The assessor will be blinded during assessments. The participants and investigators (trainers) are not possible to be blinded as it is an exercise intervention.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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 Having a Fugl-Meyer Ankle dorsiflexion-standing position score≥1

Exclusion criteria

Contraindications to exercise (e.g., unstable angina) Contraindications to MRI (e.g., pacemaker) Color blindness Neurological disorders Gait-precluding pain Comorbidity

Design outcomes

Primary

MeasureTime frameDescription
Dual-task step frequencybefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the trainingstep frequency under dual-task condition will be recorded
Dual-task cognitive performance accuracybefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the trainingNumber of correct responses will be measured during dual-task conditions

Secondary

MeasureTime frameDescription
Blood oxygenation level changes of the brainbefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the trainingBlood oxygenation level changes will be measured using Magnetic Resonance Imaging during dual-task conditions
Dual-task No.stepsbefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the trainingNo.steps under dual-task condition will be recorded
Dual-task correct reaction timebefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the trainingCorrect reaction time under dual-task condition will be recorded
Dual-task amplitude of ankle movementbefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the trainingAmplitude of ankle movement under dual-task condition will be recorded

Other

MeasureTime frameDescription
Montreal Cognitive Assessmentbefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the trainingMontreal Cognitive Assessment will be used to assess global cognition, with total points from 0-30. Higher points indicate better performance.
Fall incidencebefore the initiation of training, 6 months after trainingMonthly telephone interviews for recording fall incidence
Single-task walking speedbefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the training10-meter walking test will be used to assess single-task walking speed in meters per second
Dual-task cognitive performance timebefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the trainingTime of correct responses under dual-task condition will be measured during dual-task conditions
Dual-task ankle movement degreebefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the trainingAnkle movement degree under dual-task condition will be recorded
Dual-task walking performancebefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the training1 min Forward Walking with Serial 3 subtractions will be used to assess motor and cognitive performance during dual-task walking.
Mini Balance Evaluation Systems Testbefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the trainingMini Balance Evaluation Systems Test will be used to assess postural control and balance, with total points from 0-28. Higher points indicate better performance.
Activities-specific Balance Confidence Scalebefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the trainingActivities-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.
Trail Making Testbefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the trainingTrail Making Test will be used to assess executive function
Digit Span Testbefore the initiation of training,after 6 weeks of training, 6 weeks after termination of the trainingDigit Span Test will be used to assess working memory

Countries

China

Contacts

Primary ContactMarco Yiu Chung PANG, PhD
Marco.Pang@polyu.edu.hk+852 2766-7156

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026