Dual-task Training in Chronic Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Dual-task training group
* Behavioral: Single-task training group
* Behavioral: Flexibility and strength training group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual-task training group<br>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. | Behavioral: Dual-task training group<br>* Balance and gait exercises while simultaneously engaging in a secondary cognitive task.<br>|
| Active Comparator: Single-task training group<br>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. | Behavioral: Single-task training group<br>* Balance/gait exercises and cognitive exercises done separately.<br>|
| Active Comparator: Flexibility and strength training group<br>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. | Behavioral: Flexibility and strength training group<br>* Whole-body flexibility exercises, upper limb strengthening exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Balance, Gait, Community, Rehabilitation, Dual-task