Brain Activity Changes After Structured Cognitive-motor Exercise for People With Stroke

Using Functional Near-infrared Spectroscopy to Study the Changes in Brain Activity During Dual-task Walking and the Effects of Structured Cognitive-motor Exercise in Individuals With Stroke

To assess the effects of a dual-task exercise program on cognitive-motor interference during dual-task walking and the associated changes in brain activity.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Dual-task training; Behavioral: Single-task training; Behavioral: Control group

Detailed Description

Stroke is one of the leading causes of chronic disability in Hong Kong and other parts of the world. Mobility dysfunctions are among the most common impairments observed after stroke. Restoration of mobility is also a top priority in rehabilitation goal-setting by stroke patients. In daily life, functional ambulation in the community requires the ability to maintain walking balance while simultaneously engaging in other attention-demanding tasks (i.e., dual-tasking), such as walking when holding a conversation, or crossing the street while attending to traffic signals. There is increasing evidence that performing a cognitive task in conjunction with a mobility task would cause more severe degradation of one or both tasks among stroke patients when compared with age-matched able-bodied individuals. This phenomenon, termed "cognitive-motor interference", should warrant detailed study, since it has an important impact on community-living among people with stroke.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Yiu Chung PANG, PhD; Phone Number: 2766-7156 2766-7156; Email: Marco.Pang@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 000000
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: Marco Yiu Chung PANG, PhD; Phone Number: 2766-7156 2766-7156; Email: Marco.Pang@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of stroke confirmed by brain scan reports
• Community-living
• Stroke onset ≥ 6 months
• Aged 50 years or older
• Modified Rankin scale 1-3
• Capable of following verbal instructions
• Montreal Cognitive Assessment score ≥ 22
• Ability to walk for 1 min independently with or without a walking aid
• Not receiving formal rehabilitation elsewhere

Exclusion Criteria:

• Other neurological disorders
• Pain or other comorbidities that seriously affect the ability to walk
• Contraindications to exercise (e.g., angina).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual-task training; Mobility tasks performed in conjunction with cognitive tasks	Behavioral: Dual-task training; This group will receive 30 min of dual-task exercise training and 30 min of stretching exercises in each session. The dual-task component involves walking activities performed in conjunction with cognitive activities. For the stretching exercise component, no cognitive load will be added.
Active Comparator: Single-task training; Separate cognitive and mobility exercises	Behavioral: Single-task training; This group will undergo 30 min of single-task mobility training and another 30 min of single-task cognitive activities. The cognitive and mobility exercises will be the same as those in the dual-task group, but they will be performed separately. No extra cognitive load will be imposed during the mobility exercises. No additional motor demand will be imposed during the cognitive exercises, as the participants will be sitting.
Active Comparator: Control group; Upper limb strengthening and flexibility exercises	Behavioral: Control group; This group will undergo 30 min of stretching exercises (same as the dual-task group) and another 30 min of upper limb strengthening exercises performed primarily in the sitting or lying position. No cognitive load will be added.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dual-task gait speed	Gait speed under dual-task condition will be recorded	Through study completion, an average of 1 year
Dual-task cognitive performance	Number of correct responses will be measured during dual-task walking	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dual-task gait performance 1	Gait cadence will be measured during dual-task walking	Through study completion, an average of 1 year
Dual-task gait performance 2	Stride length will be measured during dual-task walking	Through study completion, an average of 1 year
Dual-task gait performance 3	Trunk stability will be measured during dual-task walking	Through study completion, an average of 1 year
Oxyhemoglobin concentration changes of the brain	Oxyhemoglobin concentration changes will be measured using functional near infra-red spectroscopy during dual-task walking	Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single-task walking speed	10-meter walking test will be used to assess single-task walking speed in meters per second	Through study completion, an average of 1 year
Balance 1	Mini Balance Evaluation Systems Test will be used to assess postural control, with total points from 0-28. Higher points indicate better performance.	Through study completion, an average of 1 year
Balance 2	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.	Through study completion, an average of 1 year
Cognitive performance	Stroop color word test will be used to assess executive function	Through study completion, an average of 1 year
Cognitive performance 1	Digit Span Test will be used to assess working memory	Through study completion, an average of 1 year
Cognitive performance 2	Montreal Cognitive Assessment will be used to assess global cognition, with total points from 0-30. Higher points indicate better performance.	Through study completion, an average of 1 year
Fall incidence	Monthly telephone interviews for recording fall incidence	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Research Grants Council, Hong Kong
• Investigators: Principal Investigator: Marco Yiu Chung PANG, PhD, The Hong Kong Polytechnic University; Study Director: Xun LI, MSc, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Estimated): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Dual-task training; Cognitive-motor interference
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: P0037680

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 2025 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