StrokeTOHENCT02779036
Optimizing Walking Function of Stroke Survivors by a Task-Oriented Home Exercise Program
A study testing Task-oriented home exercise and Usual Physiotherapy Care in people with Stroke, run by Mahidol University at 2 sites in Burma.
Trial summary
In a randomized-controlled study, the effects of a structured, progressive, task-oriented home exercise program to optimize walking competency will be evaluated in subacute stroke survivors. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Task-oriented home exercise and Usual Physiotherapy Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesBurma
- Study dates
- Jun 2016to Apr 2017
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either side of both type first stroke within 2 weeks to six months of onset with confirmatory diagnosis by CT Scan and MRI.
- Age between 40 to 65 years old.
- Moderate severity of stroke measured by the modified Rankin Scale (mRS- 3)
- Able to comprehend the instructions with good cognition measured by Mini-Mental State Examination (MMSE > 23).
- Postadoption stage of readiness to change measured by the Stages of Change Questionnaire (stage 4 and 5)
Who cannot join
- Diagnosed with other neurological disorder such as Parkinson's disease, peripheral nerve injury.
- Serious cardiac conditions (angina and myocardial infarction during the previous month, resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg)
- Fugl Meyer Assessment score (lower extremity) less than ≤ 21
- Significant hip, knee and ankle contracture that would limit ambulation (Fugl Meyer (ROM) ≤1 in each joint).
- Orthopedic and rheumatological disorder with weight bearing pain (Fugl Meyer (pain) ≤ 1 in hip, knee and ankle joint movement).
Trial locations and contacts
2 sites in 1 country.
Burma2 sites
National Rehabilitation Hospital
Yangon
Physical Medicine and Rehabilitation Department, Yangon General Hospital
Yangon
About this study
Official title: The Effects of a Structured, Progressive, Task-oriented Home Exercise Program on Walking Competency in Individual Post Stroke
In a randomized-controlled study, the effects of a structured, progressive, task-oriented home exercise program to optimize walking competency will be evaluated in subacute stroke survivors.
Read the detailed description
The majority of stroke individuals unable to reenter their previous community life after they have had a stroke. Reintegration of community life by optimizing walking function is a major goal of stroke rehabilitation. Because not widely available inpatient rehabilitation, discharged with incomplete recovery, limited numbers of technically trained physical therapists, financial saving, and transportation difficulty, home-based stroke rehabilitation setting has been interested in many developing countries.
Task- oriented exercise is well known and accepted approach to optimize walking function with underlying principles of motor control and motor learning theories. This approach has been used in the clinical setting with close supervision, but identification of appropriate protocol in the community environment is on progress. To date, no proper home exercise program based on task-oriental principle with minimal supervision for improving walking competency after stroke has been proposed in stroke rehabilitation.
The purpose of this study is to investigate the effects of a structured, progressive, task- oriented home exercise program on walking competency in individual post stroke.
- Conditions
- Stroke
- Being tested
- Task-oriented home exercise, Usual Physiotherapy Care
- Keywords
- Stroke, task-oriented home exercise, walking competency, Usual Physiotherapy care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-oriented home exerciseProcedure or surgery
Structured, walking related task-oriented home exercise program with three progressive steps, at moderate to high intensity, 60 minutes per session, three sessions per week for total 8 weeks.
Usual Physiotherapy CareProcedure or surgery
Deficits-oriented free active and resisted lower extremity exercises with bicycling and overground walking , 60 minutes per session, three sessions per week for total 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Task-oriented Exercise | Experimental | Structured, progressive, task-oriented, home exercise program Receives: Procedure: Task-oriented home exercise |
| Usual Care | Active comparator | Usual Physiotherapy Care Receives: Procedure: Usual Physiotherapy Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minutes Walk Test
Patients will be measured their walking distance by a blind assessor on five occasions:at baseline,1,2,5 and 8 weeks after baseline testing.
Measured: up to 8 weeks
10 Meter Walk Test
Patients will be measured their walking speed by a blind assessor on five occasions:at baseline,1,2,5 and 8 weeks after baseline testing.
Measured: up to 8 weeks
Secondary outcomes (3)
Berg Balance Scale
Patients will be measured their walking balance by a blind assessor on five occasions:at baseline,1,2,5 and 8 weeks after baseline testing.
Measured: up to 8 weeks
Dynamic Gait Index
Patients will be measured their walking adaptability by a blind assessor on two occasions:at baseline and 8 weeks after baseline testing.
Measured: Baseline and 8 weeks
Stroke Impact Scale (Participation)
Patients will be measured their community participation by a blind assessor on two occasions:at baseline and 8 weeks after baseline testing.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2017
- Study completionApr 2017
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Medical Technology, Yangon, National Rehabilitation Hospital, Myanmar, Yangon General Hospital, Myanmar
- Responsible party
- Principal investigator, Thin Thin Moe, Mahidol University
- Investigators
- Thin Thin Moe, M.Med.Tech, Principal investigator, Mahidol UniversityChutima Jalayondeja, Dr.P.H. MSc, Study chair, Mahidol UniversitySopa Pichaiyongwongdee, M.Sc. B.Sc, Study director, Mahidol UniversityVimonwan Hiengkaew, PhD. MSc, Study director, Mahidol UniversityJarugool Tretriluxana, PhD. MSc, Study director, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779036
- Sponsor's protocol ID
- 3-2016
- Acronym
- TOHE
- Status last verified
- Oct 2016
- First submitted
- 15 May 2016
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Structured, Progressive, Task-oriented Home Exercise Program on Walking Competency in Individual Post Stroke
- ClinicalTrials.gov ID
- NCT02779036
- Acronym / sponsor ID
- TOHE / 3-2016
- Conditions
- Stroke
- Keywords
- Stroke, task-oriented home exercise, walking competency, Usual Physiotherapy care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- University of Medical Technology, Yangon, National Rehabilitation Hospital, Myanmar, Yangon General Hospital, Myanmar
- Study start
- Jun 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 20 May 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.
In a randomized-controlled study, the effects of a structured, progressive, task-oriented home exercise program to optimize walking competency will be evaluated in subacute stroke survivors.
Detailed description
The majority of stroke individuals unable to reenter their previous community life after they have had a stroke. Reintegration of community life by optimizing walking function is a major goal of stroke rehabilitation. Because not widely available inpatient rehabilitation, discharged with incomplete recovery, limited numbers of technically trained physical therapists, financial saving, and transportation difficulty, home-based stroke rehabilitation setting has been interested in many developing countries.
Task- oriented exercise is well known and accepted approach to optimize walking function with underlying principles of motor control and motor learning theories. This approach has been used in the clinical setting with close supervision, but identification of appropriate protocol in the community environment is on progress. To date, no proper home exercise program based on task-oriental principle with minimal supervision for improving walking competency after stroke has been proposed in stroke rehabilitation.
The purpose of this study is to investigate the effects of a structured, progressive, task- oriented home exercise program on walking competency in individual post stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task-oriented Exercise | Experimental | Procedure: Task-oriented home exerciseStructured, progressive, task-oriented, home exercise program |
| Usual Care | Active comparator | Procedure: Usual Physiotherapy CareUsual Physiotherapy Care |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Either side of both type first stroke within 2 weeks to six months of onset with confirmatory diagnosis by CT Scan and MRI.
- Age between 40 to 65 years old.
- Moderate severity of stroke measured by the modified Rankin Scale (mRS- 3)
- Able to comprehend the instructions with good cognition measured by Mini-Mental State Examination (MMSE > 23).
- Postadoption stage of readiness to change measured by the Stages of Change Questionnaire (stage 4 and 5)
Key exclusion criteria (5 listed)
- Diagnosed with other neurological disorder such as Parkinson's disease, peripheral nerve injury.
- Serious cardiac conditions (angina and myocardial infarction during the previous month, resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg)
- Fugl Meyer Assessment score (lower extremity) less than ≤ 21
- Significant hip, knee and ankle contracture that would limit ambulation (Fugl Meyer (ROM) ≤1 in each joint).
- Orthopedic and rheumatological disorder with weight bearing pain (Fugl Meyer (pain) ≤ 1 in hip, knee and ankle joint movement).
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 |
|---|---|---|
| Task-oriented home exerciseStructured, walking related task-oriented home exercise program with three progressive steps, at moderate to high intensity, 60 minutes per session, three sessions per week for total 8 weeks. | Procedure or surgery | Task-oriented Exercise |
| Usual Physiotherapy CareDeficits-oriented free active and resisted lower extremity exercises with bicycling and overground walking , 60 minutes per session, three sessions per week for total 8 weeks. | Procedure or surgery | Usual Care |
Primary outcome
6 Minutes Walk Test
Time frame: up to 8 weeks
Patients will be measured their walking distance by a blind assessor on five occasions:at baseline,1,2,5 and 8 weeks after baseline testing.
10 Meter Walk Test
Time frame: up to 8 weeks
Patients will be measured their walking speed by a blind assessor on five occasions:at baseline,1,2,5 and 8 weeks after baseline testing.
3 secondary outcomes
Berg Balance Scale
Time frame: up to 8 weeks
Dynamic Gait Index
Time frame: Baseline and 8 weeks
Stroke Impact Scale (Participation)
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Thin Thin Moe, M.Med.Tech principal investigator
Mahidol University
Chutima Jalayondeja, Dr.P.H. MSc study chair
Mahidol University
Sopa Pichaiyongwongdee, M.Sc. B.Sc study director
Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-oriented home exercise and Usual Physiotherapy Care in people with Stroke, run by Mahidol University at 2 sites in Burma.
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 5 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: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burma. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minutes Walk Test (time frame: up to 8 weeks). The study lists 2 primary outcomes in all. 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 8 Jun 2017.