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

NCT ID: NCT06129227

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Dual-task training

Mobility tasks performed in conjunction with cognitive tasks

Group Type EXPERIMENTAL

Dual-task training

Intervention Type 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.

Single-task training

Separate cognitive and mobility exercises

Group Type ACTIVE_COMPARATOR

Single-task training

Intervention Type 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.

Control group

Upper limb strengthening and flexibility exercises

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Research Grants Council, Hong Kong

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Marco Yiu-Chung Pang

Chair professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marco Yiu Chung PANG, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Xun LI, MSc

Role: STUDY_DIRECTOR

The Hong Kong Polytechnic University

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Marco Yiu Chung PANG, PhD

Role: CONTACT

2766-7156 ext. 2766-7156

Facility Contacts

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Marco Yiu Chung PANG, PhD

Role: primary

2766-7156 ext. 2766-7156

Other Identifiers

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P0037680

Identifier Type: -

Identifier Source: org_study_id

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