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

NCT06129227 | Unknown

• 1 other identifier: P0037680
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Dual-task training; Cognitive-motor interference

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Dual-task gait performance 1

  Through study completion, an average of 1 year

• Dual-task gait performance 2

  Through study completion, an average of 1 year

• Dual-task gait performance 3

  Through study completion, an average of 1 year

• Oxyhemoglobin concentration changes of the brain

  Through study completion, an average of 1 year

Other Outcomes (7)

• Single-task walking speed

  Through study completion, an average of 1 year

• Balance 1

  Through study completion, an average of 1 year

• Balance 2

  Through study completion, an average of 1 year

Study Arms (3)

Dual-task training

EXPERIMENTAL

Mobility tasks performed in conjunction with cognitive tasks

Behavioral: Dual-task training

Single-task training

ACTIVE COMPARATOR

Separate cognitive and mobility exercises

Behavioral: Single-task training

Control group

ACTIVE COMPARATOR

Upper limb strengthening and flexibility exercises

Behavioral: Control group

Interventions

Dual-task training BEHAVIORAL

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.

Dual-task training

Single-task training BEHAVIORAL

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.

Single-task training

Control group BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Research Grants Council, Hong Kong: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, 000000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Marco Yiu Chung PANG, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

• Xun LI, MSc

  The Hong Kong Polytechnic University

  STUDY DIRECTOR

Central Study Contacts

Marco Yiu Chung PANG, PhD

CONTACT

2766-7156; Marco.Pang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This will be a single-blinded RCT. The assessor will be blinded during assessments. The participants and investigators (trainers) are not possible to be blinded as it is an exercise intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair professor

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 13, 2023
• Study Start: January 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From Dec 2025 onwards
• Access Criteria: By contacting the Principal Investigator (Prof. Marco PANG): Marco.Pang@polyu.edu.hk

Locations

HK (1)