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Dual-task Training in Chronic Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Dual-task training group
Single-task training group
Flexibility and strength training group
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Exercise, Balance, Gait, Community, Rehabilitation, Dual-task

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Dual-task training group

Single-task training group

Flexibility and strength training group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Timed-up-and-go test with and without dual-task
A walking test
Timed-up-and-go test with and without dual-task
A walking test
Timed-up-and-go test with and without dual-task
A walking test

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2014
Last Updated
November 9, 2014
Sponsor
The Hong Kong Polytechnic University
Collaborators
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02270398
Brief Title
Dual-task Training in Chronic Stroke
Official Title
Training Dual-task Balance and Walking in Community-dwelling Older Adults With Chronic Stroke: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
West China Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Exercise, Balance, Gait, Community, Rehabilitation, Dual-task

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual-task training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Single-task training group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Flexibility and strength training group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dual-task training group
Intervention Description
Balance and gait exercises while simultaneously engaging in a secondary cognitive task.
Intervention Type
Behavioral
Intervention Name(s)
Single-task training group
Intervention Description
Balance/gait exercises and cognitive exercises done separately.
Intervention Type
Behavioral
Intervention Name(s)
Flexibility and strength training group
Intervention Description
Whole-body flexibility exercises, upper limb strengthening exercises.
Primary Outcome Measure Information:
Title
Timed-up-and-go test with and without dual-task
Description
A walking test
Time Frame
week 0
Title
Timed-up-and-go test with and without dual-task
Description
A walking test
Time Frame
week 8
Title
Timed-up-and-go test with and without dual-task
Description
A walking test
Time Frame
week 16
Secondary Outcome Measure Information:
Title
10-meter walk test with and without dual-task
Description
A walking test
Time Frame
week 0
Title
10-meter walk test with and without dual-task
Description
A walking test
Time Frame
week 8
Title
10-meter walk test with and without dual-task
Description
A walking test
Time Frame
week 16
Title
Sensory organization test with and without dual-task
Description
A standing balance test
Time Frame
week 0
Title
Sensory organization test with and without dual-task
Description
A standing balance test
Time Frame
week 8
Title
Sensory organization test with and without dual-task
Description
A standing balance test
Time Frame
week 16
Title
Obstacle crossing with and without dual-task
Description
A walking test
Time Frame
week 0
Title
Obstacle crossing with and without dual-task
Description
A walking test
Time Frame
week 8
Title
Obstacle crossing with and without dual-task
Description
A walking test
Time Frame
week 16
Title
Mini-Balance Evaluations Systems Test
Description
A balance test
Time Frame
week 0
Title
Mini-Balance Evaluations Systems Test
Description
A balance test
Time Frame
week 8
Title
Mini-Balance Evaluations Systems Test
Description
A balance test
Time Frame
week 16
Title
Activities-specific balance confidence scale
Description
A questionnaire
Time Frame
week 0
Title
Activities-specific balance confidence scale
Description
A questionnaire
Time Frame
week 8
Title
Activities-specific balance confidence scale
Description
A questionnaire
Time Frame
week 16
Title
Stroke Specific Quality of Life Scale
Description
A questionnaire
Time Frame
week 0
Title
Stroke Specific Quality of Life Scale
Description
A questionnaire
Time Frame
week 8
Title
Stroke Specific Quality of Life Scale
Description
A questionnaire
Time Frame
week 16
Title
Motricity Index
Description
A muscle strength test
Time Frame
week 0
Title
Motricity Index
Description
A muscle strength test
Time Frame
week 8
Title
Motricity Index
Description
A muscle strength test
Time Frame
week 16
Title
Chedoke Arm and Hand Activity Inventory
Description
An arm function test
Time Frame
week 0
Title
Chedoke Arm and Hand Activity Inventory
Description
An arm function test
Time Frame
week 8
Title
Chedoke Arm and Hand Activity Inventory
Description
An arm function test
Time Frame
week 16
Title
Frenchay Activities Index
Description
A questionnaire
Time Frame
week 0
Title
Frenchay Activities Index
Description
A questionnaire
Time Frame
week 8
Title
Frenchay Activities Index
Description
A questionnaire
Time Frame
week 16
Title
Tinetti Assessment Tool (Gait)
Description
A walking test
Time Frame
week 0
Title
Tinetti Assessment Tool (Gait)
Description
A walking test
Time Frame
week 8
Title
Tinetti Assessment Tool (Gait)
Description
A walking test
Time Frame
week 16
Title
Incidence of fall
Description
fall follow-up using log book and monthly telephone calls
Time Frame
week 0-6 months after training
Title
Global Rating of Change score
Description
A questionnaire
Time Frame
week 8
Title
Global Rating of Change score
Description
A questionnaire
Time Frame
week 16
Title
Upper limb muscle strength
Description
dynamometry test
Time Frame
week 0
Title
Upper limb muscle strength
Description
dynamometry test
Time Frame
week 8
Title
Upper limb muscle strength
Description
dynamometry test
Time Frame
week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Echo Ouyang, BSc
Phone
27664844
Email
echo.y.ouyang@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Marco YC Pang, PhD
Phone
27667156
Email
Marco.Pang@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco YC Pang, PhD
Organizational Affiliation
Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong Polytechnic University
City
Hung Hom
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Echo Ouyang, BSc
Phone
85227664844
Email
echo.y.ouyang@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Marco YC Pang, PhD
Phone
85227667156
Email
Marco.Pang@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Marco YC Pang, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23064734
Citation
Said CM, Galea MP, Lythgo N. People with stroke who fail an obstacle crossing task have a higher incidence of falls and utilize different gait patterns compared with people who pass the task. Phys Ther. 2013 Mar;93(3):334-44. doi: 10.2522/ptj.20120200. Epub 2012 Oct 11.
Results Reference
background
PubMed Identifier
12625657
Citation
Cockburn J, Haggard P, Cock J, Fordham C. Changing patterns of cognitive-motor interference (CMI) over time during recovery from stroke. Clin Rehabil. 2003 Mar;17(2):167-73. doi: 10.1191/0269215503cr597oa.
Results Reference
background
PubMed Identifier
19201610
Citation
Silsupadol P, Lugade V, Shumway-Cook A, van Donkelaar P, Chou LS, Mayr U, Woollacott MH. Training-related changes in dual-task walking performance of elderly persons with balance impairment: a double-blind, randomized controlled trial. Gait Posture. 2009 Jun;29(4):634-9. doi: 10.1016/j.gaitpost.2009.01.006. Epub 2009 Feb 7.
Results Reference
background
PubMed Identifier
21651800
Citation
Pichierri G, Wolf P, Murer K, de Bruin ED. Cognitive and cognitive-motor interventions affecting physical functioning: a systematic review. BMC Geriatr. 2011 Jun 8;11:29. doi: 10.1186/1471-2318-11-29.
Results Reference
background
PubMed Identifier
17908563
Citation
Yang YR, Wang RY, Chen YC, Kao MJ. Dual-task exercise improves walking ability in chronic stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2007 Oct;88(10):1236-40. doi: 10.1016/j.apmr.2007.06.762.
Results Reference
background
PubMed Identifier
30571419
Citation
Pang MYC, Yang L, Ouyang H, Lam FMH, Huang M, Jehu DA. Dual-Task Exercise Reduces Cognitive-Motor Interference in Walking and Falls After Stroke. Stroke. 2018 Dec;49(12):2990-2998. doi: 10.1161/STROKEAHA.118.022157.
Results Reference
derived

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Dual-task Training in Chronic Stroke

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