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

July 2, 2024 updated by: The Hong Kong Polytechnic University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hong Kong, China, 000000
        • Recruiting
        • The Hong Kong Polytechnic University
        • Contact:
          • Marco Yiu Chung Pang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Behavioral: Dual-task training
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.
Behavioral: 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.
Active Comparator: control group
Patients receive three upper limb muscle strengthening exercise with muscle stretching per week for six weeks.
Behavioral: 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.

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
Dual-task No.steps
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
No.steps 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 correct reaction time
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Correct reaction time 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 amplitude of ankle movement
Time Frame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Amplitude of ankle movement 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 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
Monthly telephone interviews for recording fall incidence
before the initiation of training, 6 months after training
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
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

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Marco_PANG_2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study data can be provided via contacting the Principal Investigator

IPD Sharing Time Frame

From Dec 2026 onwards

IPD Sharing Access Criteria

By contacting the Principal Investigator (Prof. Marco PANG): Marco.Pang@polyu.edu.hk

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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