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Training Dual-task Balance and Walking in People With Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dual task training
Single-task training
Limbs exercise
Sponsored by
The Queen Elizabeth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Dual task training, Dual task interference, Sub-acute stroke, Physiotherapy training, Community ambulation, Balance

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of a stroke confirmed by the individual's physician, between 1 month and 6 months post-stroke onset
  • Aged ≥50
  • Community-dwelling prior to stroke onset (defined as living in one's own home or the home of a relative, friend or caregiver)
  • Medically stable
  • Montreal Cognitive Assessment (MoCA) scored ≥21
  • Ability to follow 3-step commands
  • Having motor impairment in the affected lower extremity [Chedoke McMaster Stroke Assessment (CMSA) leg and foot summative score of 4-13 out of 14)], and upper extremity (CMSA arm and hand summative score of 4-13 out of 14)
  • Having balance deficits (Mini-Balance Evaluation Systems test score <24)
  • Able to ambulate without physical assistance of another person as determined during the 10-meter walk test

Exclusion Criteria:

  • Recurrent stroke
  • Having neurological conditions other than stroke
  • significant receptive and expressive aphasia
  • Severe and uncorrected hearing or visual deficits
  • Serious musculoskeletal (e.g. amputation) or cardiovascular conditions affecting the ability to exercise (e.g. congestive heart failure), pain experienced at rest or movement, and other serious illnesses that preclude participation.

Sites / Locations

  • Queen Elizabeth HospitalRecruiting

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

Limbs exercise group

Arm Description

Subjects in this group will have 30 minutes of dual-task training with simultaneously performing balance and walking exercise and attention demanding tasks, and 30 minutes of stretching exercises. The training program will last for 8 weeks with frequency of 2 sessions a week.

Subjects in this group will have single-task training with 30 minutes of balance and walking exercise and 30 minutes of attention demanding task performed separately. The training program will last for 8 weeks with frequency of 2 sessions a week.

Subjects in this group will have stretching and strengthening exercise for 60 minutes. The training program will last for 8 weeks with frequency of 2 sessions a week.

Outcomes

Primary Outcome Measures

Degree of the dual-task interference
It will be assessed by calculating the percentage of the difference between single task performance (2 walking tasks and 2 balance tasks) and dual task performance of the 2 walking tasks and 2 balance tasks while engaging in 3 attention demanding tasks.

Secondary Outcome Measures

Standing balance with eyes opened in dual task conditions
It will be evaluated by Smart Balance System (NeuroCom International Inc., Clackamas, USA). An equilibrium score will be obtained.
Standing balance with eyes closed in dual task conditions
It will be evaluated by Smart Balance System (NeuroCom International Inc., Clackamas, USA). An equilibrium score will be obtained.
10 metre walk test in dual task conditions
Subjects will be requested to walk along a 14-meter walkway at a self-selected speed. Time taken for the intermediate 10 meters will be recorded.
Obstacle crossing test in dual task conditions
Subjects will be asked to walk at their fastest safe speed to cross seven 4-cm-high obstacles along a 10 meters-walkway. Time taken to complete the task will be recorded.
Chinese version of Activities-specific Balance Confidence (ABC) Scale
Evaluating the subject's balance self efficacy
Chedoke Arm and Hand Activity Inventory (short form)
Performance-based measure for upper limb function
Incidence of falls
Fall incidence will be recorded using log book and monthly telephone calls

Full Information

First Posted
April 24, 2016
Last Updated
April 26, 2016
Sponsor
The Queen Elizabeth Hospital
Collaborators
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02753322
Brief Title
Training Dual-task Balance and Walking in People With Stroke
Official Title
Training Dual-task Balance and Walking in People With Stroke: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Stroke is one of the most common chronic disabling conditions in Hong Kong. People after stroke may suffer from certain degree of physical impairment and disability. Resuming safe ambulation in the community appears to be a big challenge to them as it always involves the simultaneous performance of two or more tasks (dual task) such as walking and talking with someone, walking and recalling the shopping list etc. Numerous studies has demonstrated that the interference from dual tasks (dual task interference) may significantly impact the recovery of the functional walking. To date, the relevance of dual task walking to daily community is widely documented and the ability of managing dual task is therefore particularly important. Evidences supported that dual task training showed its promising effect on the balance and walking performance amongst people with neurological disorders, such as chronic stroke. In light of this, the introduction of dual task based balance and walking training into physiotherapy program for stroke patient may enhance the balance and walking performance and hence promote successful community ambulation. Yet, there is limited evidence on its effect in sub-acute stroke. Objective: To examine the effectiveness of a dual-task based balance and walking training program on performance and dual task interference in balance and walking ability, balance self-efficacy and incidence of falls in people with sub-acute stroke
Detailed Description
An assessor-blind, randomized control trial will be conducted. Eighty-four people with sub-acute stroke and fulfill the eligibility criteria will be recruited from the medical wards of the Queen Elizabeth Hospital (QEH) or from the Physiotherapy Department of the QEH. Subjects will be randomly allocated into either dual-task training (DT) group (n=28) or single-task training (ST) group (n=28) or Control (C) group (n=28) by 1:1:1 randomization sequence after baseline evaluation. All subjects will receive usual physiotherapy training. Subjects in the DT group will undergo 30 minutes of dual task training with simultaneously performing balance and walking exercise and attention demanding tasks, and 30 minutes of stretching exercises whereas those in the ST group will undergo single task training with 30 minutes of balance and walking exercise and 30 minutes of attention demanding task performed separately. Subjects in the control group will receive stretching and strengthening exercise only. The training program will last for 8 weeks with frequency of 2 sessions a week and duration of 60 minutes per session. The degree of the dual-task interference, the balance and walking performance in dual task conditions will be evaluated at three time points: (1) Baseline (within one week before the intervention (2) within one week after completion of training (3) 8 weeks after the completion of training by blinded assessors. Also, the subjects will have monthly telephone follow up on the fall incidence for 6 months after completion of the program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Dual task training, Dual task interference, Sub-acute stroke, Physiotherapy training, Community ambulation, Balance

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
Subjects in this group will have 30 minutes of dual-task training with simultaneously performing balance and walking exercise and attention demanding tasks, and 30 minutes of stretching exercises. The training program will last for 8 weeks with frequency of 2 sessions a week.
Arm Title
Single-task training group
Arm Type
Active Comparator
Arm Description
Subjects in this group will have single-task training with 30 minutes of balance and walking exercise and 30 minutes of attention demanding task performed separately. The training program will last for 8 weeks with frequency of 2 sessions a week.
Arm Title
Limbs exercise group
Arm Type
Active Comparator
Arm Description
Subjects in this group will have stretching and strengthening exercise for 60 minutes. The training program will last for 8 weeks with frequency of 2 sessions a week.
Intervention Type
Other
Intervention Name(s)
Dual task training
Intervention Description
Balance and walking exercises with simultaneously engaging in attention demanding tasks
Intervention Type
Other
Intervention Name(s)
Single-task training
Intervention Description
Balance and walking exercises and and attention demanding task performed separately
Intervention Type
Other
Intervention Name(s)
Limbs exercise
Intervention Description
Stretching and strengthening exercises
Primary Outcome Measure Information:
Title
Degree of the dual-task interference
Description
It will be assessed by calculating the percentage of the difference between single task performance (2 walking tasks and 2 balance tasks) and dual task performance of the 2 walking tasks and 2 balance tasks while engaging in 3 attention demanding tasks.
Time Frame
Baseline, 8 weeks, 16 weeks
Secondary Outcome Measure Information:
Title
Standing balance with eyes opened in dual task conditions
Description
It will be evaluated by Smart Balance System (NeuroCom International Inc., Clackamas, USA). An equilibrium score will be obtained.
Time Frame
Baseline, 8 weeks, 16 weeks
Title
Standing balance with eyes closed in dual task conditions
Description
It will be evaluated by Smart Balance System (NeuroCom International Inc., Clackamas, USA). An equilibrium score will be obtained.
Time Frame
Baseline, 8 weeks, 16 weeks
Title
10 metre walk test in dual task conditions
Description
Subjects will be requested to walk along a 14-meter walkway at a self-selected speed. Time taken for the intermediate 10 meters will be recorded.
Time Frame
Baseline, 8 weeks, 16 weeks
Title
Obstacle crossing test in dual task conditions
Description
Subjects will be asked to walk at their fastest safe speed to cross seven 4-cm-high obstacles along a 10 meters-walkway. Time taken to complete the task will be recorded.
Time Frame
Baseline, 8 weeks, 16 weeks
Title
Chinese version of Activities-specific Balance Confidence (ABC) Scale
Description
Evaluating the subject's balance self efficacy
Time Frame
Baseline, 8 weeks, 16 weeks
Title
Chedoke Arm and Hand Activity Inventory (short form)
Description
Performance-based measure for upper limb function
Time Frame
Baseline, 8 weeks, 16 weeks
Title
Incidence of falls
Description
Fall incidence will be recorded using log book and monthly telephone calls
Time Frame
From baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of a stroke confirmed by the individual's physician, between 1 month and 6 months post-stroke onset Aged ≥50 Community-dwelling prior to stroke onset (defined as living in one's own home or the home of a relative, friend or caregiver) Medically stable Montreal Cognitive Assessment (MoCA) scored ≥21 Ability to follow 3-step commands Having motor impairment in the affected lower extremity [Chedoke McMaster Stroke Assessment (CMSA) leg and foot summative score of 4-13 out of 14)], and upper extremity (CMSA arm and hand summative score of 4-13 out of 14) Having balance deficits (Mini-Balance Evaluation Systems test score <24) Able to ambulate without physical assistance of another person as determined during the 10-meter walk test Exclusion Criteria: Recurrent stroke Having neurological conditions other than stroke significant receptive and expressive aphasia Severe and uncorrected hearing or visual deficits Serious musculoskeletal (e.g. amputation) or cardiovascular conditions affecting the ability to exercise (e.g. congestive heart failure), pain experienced at rest or movement, and other serious illnesses that preclude participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret WY POON, MSc
Phone
852-3506 2603
Email
pwy751@ha.org.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Sally PC WAN, MSc
Phone
852-3506 7315
Email
wpcz01@ha.org.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret WY POON, MSc
Organizational Affiliation
The Queen Elizabeth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wai Yee Margaret POON, MSc
Phone
852-3506 2603
Email
pwy751@ha.org.hk
First Name & Middle Initial & Last Name & Degree
PC Sally WAN, MSc
Phone
852-3506 7315
Email
wpcz01@ha.org.hk
First Name & Middle Initial & Last Name & Degree
Wai Yee Margaret POON, MSc
First Name & Middle Initial & Last Name & Degree
PC Sally WAN, MSc
First Name & Middle Initial & Last Name & Degree
SH Bryan CHEE, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Training Dual-task Balance and Walking in People With Stroke

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