Chronic StrokeNCT02364232
Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation
A study testing bilateral training with and without mirror feedback in people with Chronic Stroke, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
The purpose of this study was to compare the treatment effects of home-based or clinic-based bilateral training with and without mirror feedback programon on physiological markers, sensorimotor, cognition, daily functions, and participation among patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- bilateral training with and without mirror feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesTaiwan
- Study dates
- Sep 2014to 12 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The most recent stroke was between 1 month and 5 years
- No serious cognitive impairment (MMSE≥21)
- FMA score =18-62
- No serious muscle spasticity in shoulder, elbow, wrist and finger (MAS≤3)
- Modified rankin Scale=2 to 4
Who cannot join
- Aphasia that might interfere with understanding instructions
- Stroke in areas other than the brain and brainstem, such as the cerebellum
- other neurological disease, such as dementia
- Muscle and joint have serious pain and inflammatory swelling in affected side.
- Cannot control hypertension, heart disease and serious throbosis
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Chang Gung Memorial Hospital
Kaohsiung County
Chang Gung Memorial Hospital
Taoyuan County
About this study
Official title: Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation: Bilateral Training With and Without Mirror Feedback Program
The purpose of this study was to compare the treatment effects of home-based or clinic-based bilateral training with and without mirror feedback programon on physiological markers, sensorimotor, cognition, daily functions, and participation among patients with chronic stroke.
- Conditions
- Chronic Stroke
- Being tested
- bilateral training with and without mirror feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral training with and without mirror feedbackBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Home-based | Experimental | Participants in home-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the home-based training, a four-week wash-out period followed. Then, patients will receive the clinic-based training for 4 continuous weeks.
Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed. Receives: Behavioral: bilateral training with and without mirror feedback |
| Clinic-based | Active comparator | Participants in clinic-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the clinic-based training, a four-week wash-out period followed. Then, patients will receive the home-based training for 4 continuous weeks.
Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed. Receives: Behavioral: bilateral training with and without mirror feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Myer Assessment, FMA
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Mini-Mental State Exam, MMSE
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
pinch and grasp dynamometer
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Modified Ashworth Scale, MAS
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Revised Nottingham Sensory Assessment
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
10-Meter Walking Test, 10MWT
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Box and Block Test, BBT
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Wolf Motor Function Test, WMFT
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Chedoke Arm and Hand Activity Inventory
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Canadian Occupational Performance Measure, COPM
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Nottingham Extended Activities of Daily Living, NEADL
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
ABILHAND Questionnaire
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Motor Activity Log, MAL
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Actigraphy
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Stroke Impact Scale, SIS
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
The World Health Organization Quality of Life -Brief version, WHOQOL-BRE
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Medical Research Council scale,MRC
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
6 minute walk test
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
The Euroqol Quality of Life Scale
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Lawton-Brody IADL Scale
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Pittsburg Sleep Quality Index
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Secondary outcomes (10)
Montreal Cognitive Assessment, MoCA
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Minnesota Rate of Manipulation Test during dual Task
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Stroop Test
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Modified Rankin Scale, mRS
Measured: baseline
30 second sit-to-stand test
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Timed up and go test
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
The stroke self-efficacy questionnaire
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
BDI-II，Beck Depression Inventory II
Measured: Change from baseline up to 4 weeks immediately after the completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startSep 2014
- Primary completion12 Apr 2017
- Study completion12 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364232
- Sponsor's protocol ID
- 103-3962A3
- Status last verified
- Nov 2016
- First submitted
- 14 Jan 2015
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hsieh YW, Chang KC, Hung JW, Wu CY, Fu MH, Chen CC. Effects of Home-Based Versus Clinic-Based Rehabilitation Combining Mirror Therapy and Task-Specific Training for Patients With Stroke: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2399-2407. doi: 10.1016/j.apmr.2018.03.017. Epub 2018 Apr 25.
PubMed 29702070
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation: Bilateral Training With and Without Mirror Feedback Program
- ClinicalTrials.gov ID
- NCT02364232
- Acronym / sponsor ID
- 103-3962A3
- Conditions
- Chronic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 12 Apr 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 18 Feb 2015 (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.
The purpose of this study was to compare the treatment effects of home-based or clinic-based bilateral training with and without mirror feedback programon on physiological markers, sensorimotor, cognition, daily functions, and participation among patients with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based | Experimental | Behavioral: bilateral training with and without mirror feedbackParticipants in home-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the home-based training, a four-week wash-out period followed. Then, patients will receive the clinic-based training for 4 continuous weeks. Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed. |
| Clinic-based | Active comparator | Behavioral: bilateral training with and without mirror feedbackParticipants in clinic-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the clinic-based training, a four-week wash-out period followed. Then, patients will receive the home-based training for 4 continuous weeks. Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The most recent stroke was between 1 month and 5 years
- No serious cognitive impairment (MMSE≥21)
- FMA score =18-62
- No serious muscle spasticity in shoulder, elbow, wrist and finger (MAS≤3)
- Modified rankin Scale=2 to 4
Key exclusion criteria (5 listed)
- Aphasia that might interfere with understanding instructions
- Stroke in areas other than the brain and brainstem, such as the cerebellum
- other neurological disease, such as dementia
- Muscle and joint have serious pain and inflammatory swelling in affected side.
- Cannot control hypertension, heart disease and serious throbosis
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 |
|---|---|---|
| bilateral training with and without mirror feedback | Behavioural | Clinic-based, Home-based |
Primary outcome
Fugl-Myer Assessment, FMA
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Mini-Mental State Exam, MMSE
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
pinch and grasp dynamometer
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Modified Ashworth Scale, MAS
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Revised Nottingham Sensory Assessment
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
10-Meter Walking Test, 10MWT
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Box and Block Test, BBT
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Wolf Motor Function Test, WMFT
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Chedoke Arm and Hand Activity Inventory
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Canadian Occupational Performance Measure, COPM
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Nottingham Extended Activities of Daily Living, NEADL
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
ABILHAND Questionnaire
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Motor Activity Log, MAL
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Actigraphy
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Stroke Impact Scale, SIS
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
The World Health Organization Quality of Life -Brief version, WHOQOL-BRE
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Medical Research Council scale,MRC
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
6 minute walk test
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
The Euroqol Quality of Life Scale
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Lawton-Brody IADL Scale
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Pittsburg Sleep Quality Index
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
10 secondary outcomes
Montreal Cognitive Assessment, MoCA
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Minnesota Rate of Manipulation Test during dual Task
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Stroop Test
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Modified Rankin Scale, mRS
Time frame: baseline
30 second sit-to-stand test
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Timed up and go test
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
The stroke self-efficacy questionnaire
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
BDI-II，Beck Depression Inventory II
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
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 19 May 2017.
- Derived from this study: PubMed 29702070Hsieh YW, Chang KC, Hung JW, Wu CY, Fu MH, Chen CC. Effects of Home-Based Versus Clinic-Based Rehabilitation Combining Mirror Therapy and Task-Specific Training for Patients With Stroke: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2399-2407. doi: 10.1016/j.apmr.2018.03.017. Epub 2018 Apr 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral training with and without mirror feedback in people with Chronic Stroke, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
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 19 May 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 Taiwan. 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?
Fugl-Myer Assessment, FMA (time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02364232, which also lists 1 linked publication.
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 19 May 2017.