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

Stroke Clinical Trial

— COGMOTION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06362512
• Other study ID #: Marco_PANG_2024
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2026

Study information

• Verified date: April 2023
• Source: The Hong Kong Polytechnic University
• Contact: Marco Yiu Chung PANG, PhD
• Phone: +852 2766-7156
• Email: Marco.Pang[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Dual-task training
participants receive three 60-minute COGMOTION dual-task exercise sessions per week for six consecutive weeks.
• Single-task training
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 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.

Locations

Country	Name	City	State
China	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Single-task walking speed	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
Other	Dual-task walking performance	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
Other	Mini Balance Evaluation Systems Test	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
Other	Activities-specific Balance Confidence Scale	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
Other	Trail Making Test	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
Other	Digit Span Test	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
Other	Montreal Cognitive Assessment	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
Other	Fall incidence	Monthly telephone interviews for recording fall incidence	before the initiation of training, 6 months after training
Other	Dual-task ankle movement degree	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
Other	Dual-task cognitive performance time	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
Primary	Dual-task step frequency	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
Primary	Dual-task cognitive performance accuracy	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	Blood oxygenation level changes of the brain	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