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

November 10, 2023 updated by: Marco Yiu-Chung Pang, The Hong Kong Polytechnic University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 000000
        • Recruiting
        • The Hong Kong Polytechnic University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dual-task gait speed
Time Frame: Through study completion, an average of 1 year
Gait speed under dual-task condition will be recorded
Through study completion, an average of 1 year
Dual-task cognitive performance
Time Frame: Through study completion, an average of 1 year
Number of correct responses will be measured during dual-task walking
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dual-task gait performance 1
Time Frame: Through study completion, an average of 1 year
Gait cadence will be measured during dual-task walking
Through study completion, an average of 1 year
Dual-task gait performance 2
Time Frame: Through study completion, an average of 1 year
Stride length will be measured during dual-task walking
Through study completion, an average of 1 year
Dual-task gait performance 3
Time Frame: Through study completion, an average of 1 year
Trunk stability will be measured during dual-task walking
Through study completion, an average of 1 year
Oxyhemoglobin concentration changes of the brain
Time Frame: Through study completion, an average of 1 year
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Single-task walking speed
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
Stroop color word test will be used to assess executive function
Through study completion, an average of 1 year
Cognitive performance 1
Time Frame: Through study completion, an average of 1 year
Digit Span Test will be used to assess working memory
Through study completion, an average of 1 year
Cognitive performance 2
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
Monthly telephone interviews for recording fall incidence
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Research Grants Council, Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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