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

NCT ID: NCT06362512

Last Updated: 2024-07-05

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-17

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

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 randomized controlled trial . 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

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dual-task group

patients receive three dual motor-cognitive exercise training per week for six weeks.

Group Type EXPERIMENTAL

Dual-task training

Intervention Type BEHAVIORAL

participants receive three 60-minute COGMOTION dual-task exercise sessions per week for six consecutive weeks.

single-task group

Patients receive three separate cognitive and mobility exercises per week for six weeks.

Group Type ACTIVE_COMPARATOR

Single-task training

Intervention Type BEHAVIORAL

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.

control group

Patients receive three upper limb muscle strengthening exercise with muscle stretching per week for six weeks.

Group Type ACTIVE_COMPARATOR

Upper limb strengthening exercise

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dual-task training

participants receive three 60-minute COGMOTION dual-task exercise sessions per week for six consecutive weeks.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Hong Kong Polytechnic University

Hong Kong, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marco Yiu Chung PANG, PhD

Role: CONTACT

+852 2766-7156 ext. 2766-7156

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marco Yiu Chung Pang, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Marco_PANG_2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.