- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02753322
Training Dual-task Balance and Walking in People With Stroke
Training Dual-task Balance and Walking in People With Stroke: a Randomized Controlled Trial
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Margaret WY POON, MSc
- Phone Number: 852-3506 2603
- Email: pwy751@ha.org.hk
Study Contact Backup
- Name: Sally PC WAN, MSc
- Phone Number: 852-3506 7315
- Email: wpcz01@ha.org.hk
Study Locations
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-
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Hong Kong, China
- Recruiting
- Queen Elizabeth Hospital
-
Contact:
- Wai Yee Margaret POON, MSc
- Phone Number: 852-3506 2603
- Email: pwy751@ha.org.hk
-
Contact:
- PC Sally WAN, MSc
- Phone Number: 852-3506 7315
- Email: wpcz01@ha.org.hk
-
Principal Investigator:
- Wai Yee Margaret POON, MSc
-
Sub-Investigator:
- PC Sally WAN, MSc
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Sub-Investigator:
- SH Bryan CHEE, MSc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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
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. |
Balance and walking exercises with simultaneously engaging in attention demanding tasks
|
Active Comparator: Single-task training group
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. |
Balance and walking exercises and and attention demanding task performed separately
|
Active Comparator: Limbs exercise group
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. |
Stretching and strengthening exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of the dual-task interference
Time Frame: Baseline, 8 weeks, 16 weeks
|
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.
|
Baseline, 8 weeks, 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standing balance with eyes opened in dual task conditions
Time Frame: Baseline, 8 weeks, 16 weeks
|
It will be evaluated by Smart Balance System (NeuroCom International Inc., Clackamas, USA).
An equilibrium score will be obtained.
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Baseline, 8 weeks, 16 weeks
|
Standing balance with eyes closed in dual task conditions
Time Frame: Baseline, 8 weeks, 16 weeks
|
It will be evaluated by Smart Balance System (NeuroCom International Inc., Clackamas, USA).
An equilibrium score will be obtained.
|
Baseline, 8 weeks, 16 weeks
|
10 metre walk test in dual task conditions
Time Frame: Baseline, 8 weeks, 16 weeks
|
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.
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Baseline, 8 weeks, 16 weeks
|
Obstacle crossing test in dual task conditions
Time Frame: Baseline, 8 weeks, 16 weeks
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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.
|
Baseline, 8 weeks, 16 weeks
|
Chinese version of Activities-specific Balance Confidence (ABC) Scale
Time Frame: Baseline, 8 weeks, 16 weeks
|
Evaluating the subject's balance self efficacy
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Baseline, 8 weeks, 16 weeks
|
Chedoke Arm and Hand Activity Inventory (short form)
Time Frame: Baseline, 8 weeks, 16 weeks
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Performance-based measure for upper limb function
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Baseline, 8 weeks, 16 weeks
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Incidence of falls
Time Frame: From baseline to 6 months
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Fall incidence will be recorded using log book and monthly telephone calls
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From baseline to 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Margaret WY POON, MSc, The Queen Elizabeth Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KC/KE-15-0185/ER-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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