StrokeNCT02753322
Training Dual-task Balance and Walking in People With Stroke
A study testing Dual task training, Single-task training and Limbs exercise in people with Stroke, run by The Queen Elizabeth Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- Dual task training, Single-task training and Limbs exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Queen Elizabeth Hospital
Hong Kong
Wai Yee Margaret POON, MSc, 852-3506 2603, pwy751@ha.org.hk
PC Sally WAN, MSc, 852-3506 7315, wpcz01@ha.org.hk
About this study
Official title: 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
Read the 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.
- Conditions
- Stroke
- Being tested
- Dual task training, Single-task training, Limbs exercise
- Keywords
- Dual task training, Dual task interference, Sub-acute stroke, Physiotherapy training, Community ambulation, Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual task trainingOther
Balance and walking exercises with simultaneously engaging in attention demanding tasks
Single-task trainingOther
Balance and walking exercises and and attention demanding task performed separately
Limbs exerciseOther
Stretching and strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Dual-task training group | Experimental | 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. Receives: Other: Dual task training |
| Single-task training group | Active comparator | 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. Receives: Other: Single-task training |
| Limbs exercise group | Active comparator | 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. Receives: Other: Limbs exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks, 16 weeks
Secondary outcomes (7)
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.
Measured: Baseline, 8 weeks, 16 weeks
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.
Measured: Baseline, 8 weeks, 16 weeks
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.
Measured: Baseline, 8 weeks, 16 weeks
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.
Measured: Baseline, 8 weeks, 16 weeks
Chinese version of Activities-specific Balance Confidence (ABC) Scale
Evaluating the subject's balance self efficacy
Measured: Baseline, 8 weeks, 16 weeks
Chedoke Arm and Hand Activity Inventory (short form)
Performance-based measure for upper limb function
Measured: Baseline, 8 weeks, 16 weeks
Incidence of falls
Fall incidence will be recorded using log book and monthly telephone calls
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Queen Elizabeth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, POON Margaret Wai Yee, The Queen Elizabeth Hospital
- Investigators
- Margaret WY POON, MSc, Principal investigator, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753322
- Sponsor's protocol ID
- KC/KE-15-0185/ER-3
- Status last verified
- Apr 2016
- First submitted
- 24 Apr 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Dual-task Balance and Walking in People With Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02753322
- Acronym / sponsor ID
- KC/KE-15-0185/ER-3
- Conditions
- Stroke
- Keywords
- Dual task training, Dual task interference, Sub-acute stroke, Physiotherapy training, Community ambulation, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- The Queen Elizabeth HospitalUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- Apr 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dual-task training group | Experimental | Other: Dual task trainingSubjects 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. |
| Single-task training group | Active comparator | Other: Single-task trainingSubjects 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. |
| Limbs exercise group | Active comparator | Other: Limbs exerciseSubjects 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. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual task trainingBalance and walking exercises with simultaneously engaging in attention demanding tasks | Other | Dual-task training group |
| Single-task trainingBalance and walking exercises and and attention demanding task performed separately | Other | Single-task training group |
| Limbs exerciseStretching and strengthening exercises | Other | Limbs exercise group |
Primary outcome
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.
7 secondary outcomes
Standing balance with eyes opened in dual task conditions
Time frame: Baseline, 8 weeks, 16 weeks
Standing balance with eyes closed in dual task conditions
Time frame: Baseline, 8 weeks, 16 weeks
10 metre walk test in dual task conditions
Time frame: Baseline, 8 weeks, 16 weeks
Obstacle crossing test in dual task conditions
Time frame: Baseline, 8 weeks, 16 weeks
Chinese version of Activities-specific Balance Confidence (ABC) Scale
Time frame: Baseline, 8 weeks, 16 weeks
Chedoke Arm and Hand Activity Inventory (short form)
Time frame: Baseline, 8 weeks, 16 weeks
Incidence of falls
Time frame: From baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret WY POON, MSc principal investigator
The Queen Elizabeth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual task training, Single-task training and Limbs exercise in people with Stroke, run by The Queen Elizabeth Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margaret WY POON, MSc (852-3506 2603, pwy751@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of the dual-task interference (time frame: Baseline, 8 weeks, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.