Dual-task Training in Chronic Stroke

November 9, 2014 updated by: Marco Yiu-Chung Pang, The Hong Kong Polytechnic University

Training Dual-task Balance and Walking in Community-dwelling Older Adults With Chronic Stroke: a Randomized Controlled Trial

Background Functional community ambulation not only requires a critical level of postural control and walking skills, but also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There is evidence showed that dual-task balance and gait performance is significantly impaired after stroke. Increasing evidence also suggests that dual-task balance and gait performance is useful for predicting falls among individuals with stroke. Considering the high clinical relevance of dual-task balance and gait performance, it is essential that stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task balance and gait training to enhance dual-task performance is thus necessary to promote community ambulation and reintegration.

Study Aim The aim of this Introduction Many individuals after stroke continue to cope with residual physical impairments after discharge from hospital. One of the major problems encountered by people after stroke is community reintegration. Functional community ambulation not only requires a critical level of postural control and walking skills, but also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There has been an increasing awareness of the importance of dual-task gait performance in community-dwelling individuals with stroke in the past few years.

There is evidence showed that dual-task balance and gait performance is significantly impaired after stroke. Increasing evidence also suggests that dual-task balance and gait performance is useful for predicting falls among individuals with stroke. Considering the high clinical relevance of dual-task balance and gait performance, it is essential that stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task balance and gait training to enhance dual-task performance is thus necessary to promote community ambulation and reintegration.

Study Aim This will be a single-blinded randomized controlled trial (RCT).The aim of this study is to examine the efficacy of a dual-task exercise program on cognitive-motor interference in balance and walking tasks, balance self-efficacy, participation in everyday activities, community reintegration and incidence of falls among individuals with chronic stroke.

Study Overview

Detailed Description

Introduction Many individuals after stroke continue to cope with residual physical impairments after discharge from hospital. One of the major problems encountered by people after stroke is community reintegration. Functional community ambulation not only requires a critical level of postural control and walking skills, but also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There has been an increasing awareness of the importance of dual-task gait performance in community-dwelling individuals with stroke in the past few years.

There is evidence showed that dual-task balance and gait performance is significantly impaired after stroke. Increasing evidence also suggests that dual-task balance and gait performance is useful for predicting falls among individuals with stroke. Considering the high clinical relevance of dual-task balance and gait performance, it is essential that stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task balance and gait training to enhance dual-task performance is thus necessary to promote community ambulation and reintegration.

Study Aim The aim of this study is to examine the efficacy of a dual-task exercise program on cognitive-motor interference in balance and walking tasks, balance self-efficacy, participation in everyday activities, community reintegration and incidence of falls among individuals with chronic stroke.

Study design

This will be a single-blinded randomized controlled trial (RCT). After baseline evaluation, subjects will be randomly allocated to one of the three groups: (1) dual-task training group, (2) single-task training group, (3) strengthening and flexibility exercise group (controls), using a 1:1:1 randomization sequence.

Measurements Outcomes will be used to compare the therapeutic effects of the 3 treatment groups. The outcome measurements (except data on incidence of falls) will take place at 3 time points: (1) within one week before initiation of intervention (baseline), (2) within one week after completion of training, (3) 8 weeks after completion of training. The fall data will be collected on a monthly basis until 6 months after termination of the intervention period. All assessments will be performed by a researcher who is blinded to group allocation.

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • 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 Locations

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

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of a stroke
  • more than 6 months of stroke onset
  • aged 50 years or above
  • community-dwelling
  • medically stable
  • score ≥21 on the Montreal Cognitive Assessment (MoCA)
  • score ≤ 25 on the Mini Balance Evaluation Systems Test (Mini-BESTest)
  • able to ambulate without physical assistance of another person as determined during the 10-meter walk test
  • ability to follow 3-step commands

Exclusion Criteria:

  • having neurological conditions other than stroke
  • not community-dwelling prior to the stroke event
  • significant receptive and expressive aphasia
  • severe and uncorrected hearing or visual deficits
  • serious musculoskeletal disorders (e.g. amputation)
  • serious cardiovascular conditions affecting the ability to participate in exercise training
  • pain experienced at rest or movement
  • other serious illnesses that preclude participation

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
Intervention / Treatment
Experimental: Dual-task training group
Participants in this group will receive dual-task balance and gait training for half hour and relaxation exercise for another half hour in each session. There will be 3 sessions per week for 8 weeks.
Balance and gait exercises while simultaneously engaging in a secondary cognitive task.
Active Comparator: Single-task training group
This group of subjects will participate in single-task gait and balance activities for half hour and single-task cognitive training in sitting position for another half hour in each session. There will be 3 sessions per week for 8 weeks.
Balance/gait exercises and cognitive exercises done separately.
Active Comparator: Flexibility and strength training group
The subjects in this group will engage in flexibility exercises and upper limb strengthening exercises for one hour in each session. There will be 3 sessions per week for 8 weeks.
Whole-body flexibility exercises, upper limb strengthening exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed-up-and-go test with and without dual-task
Time Frame: week 0
A walking test
week 0
Timed-up-and-go test with and without dual-task
Time Frame: week 8
A walking test
week 8
Timed-up-and-go test with and without dual-task
Time Frame: week 16
A walking test
week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10-meter walk test with and without dual-task
Time Frame: week 0
A walking test
week 0
10-meter walk test with and without dual-task
Time Frame: week 8
A walking test
week 8
10-meter walk test with and without dual-task
Time Frame: week 16
A walking test
week 16
Sensory organization test with and without dual-task
Time Frame: week 0
A standing balance test
week 0
Sensory organization test with and without dual-task
Time Frame: week 8
A standing balance test
week 8
Sensory organization test with and without dual-task
Time Frame: week 16
A standing balance test
week 16
Obstacle crossing with and without dual-task
Time Frame: week 0
A walking test
week 0
Obstacle crossing with and without dual-task
Time Frame: week 8
A walking test
week 8
Obstacle crossing with and without dual-task
Time Frame: week 16
A walking test
week 16
Mini-Balance Evaluations Systems Test
Time Frame: week 0
A balance test
week 0
Mini-Balance Evaluations Systems Test
Time Frame: week 8
A balance test
week 8
Mini-Balance Evaluations Systems Test
Time Frame: week 16
A balance test
week 16
Activities-specific balance confidence scale
Time Frame: week 0
A questionnaire
week 0
Activities-specific balance confidence scale
Time Frame: week 8
A questionnaire
week 8
Activities-specific balance confidence scale
Time Frame: week 16
A questionnaire
week 16
Stroke Specific Quality of Life Scale
Time Frame: week 0
A questionnaire
week 0
Stroke Specific Quality of Life Scale
Time Frame: week 8
A questionnaire
week 8
Stroke Specific Quality of Life Scale
Time Frame: week 16
A questionnaire
week 16
Motricity Index
Time Frame: week 0
A muscle strength test
week 0
Motricity Index
Time Frame: week 8
A muscle strength test
week 8
Motricity Index
Time Frame: week 16
A muscle strength test
week 16
Chedoke Arm and Hand Activity Inventory
Time Frame: week 0
An arm function test
week 0
Chedoke Arm and Hand Activity Inventory
Time Frame: week 8
An arm function test
week 8
Chedoke Arm and Hand Activity Inventory
Time Frame: week 16
An arm function test
week 16
Frenchay Activities Index
Time Frame: week 0
A questionnaire
week 0
Frenchay Activities Index
Time Frame: week 8
A questionnaire
week 8
Frenchay Activities Index
Time Frame: week 16
A questionnaire
week 16
Tinetti Assessment Tool (Gait)
Time Frame: week 0
A walking test
week 0
Tinetti Assessment Tool (Gait)
Time Frame: week 8
A walking test
week 8
Tinetti Assessment Tool (Gait)
Time Frame: week 16
A walking test
week 16
Incidence of fall
Time Frame: week 0-6 months after training
fall follow-up using log book and monthly telephone calls
week 0-6 months after training
Global Rating of Change score
Time Frame: week 8
A questionnaire
week 8
Global Rating of Change score
Time Frame: week 16
A questionnaire
week 16
Upper limb muscle strength
Time Frame: week 0
dynamometry test
week 0
Upper limb muscle strength
Time Frame: week 8
dynamometry test
week 8
Upper limb muscle strength
Time Frame: week 16
dynamometry test
week 16

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

October 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 17, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

November 11, 2014

Last Update Submitted That Met QC Criteria

November 9, 2014

Last Verified

November 1, 2014

More Information

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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