Cerebrovascular AccidentsNCT00564005
Mechanism and Efficacy of Rehabilitation Approaches
A study testing Constraint-induced therapy (CIT), Bilateral arm training (BAT) and Combined therapy (CT) in people with Cerebrovascular Accidents, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Identify the possible mechanisms and the relative effectiveness of existing rehabilitation approaches that target upper extremity deficits of stroke patients on the ground that these approaches are based on neuroplasticity principles and sound motor control theories. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cerebrovascular Accidents
- What is being tested?
- Constraint-induced therapy (CIT), Bilateral arm training (BAT) and Combined therapy (CT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to Dec 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a first-ever clinical cerebrovascular accident patients
- at least 6 months post-stroke onset
- premorbid right-hand dominance
- demonstration of Brunnstrom stage III of the affected upper extremity
- no excessive spasticity in the joints of the affected upper extremity
Who cannot join
- a score of less than 24 on the Mini Mental State Exam
- poor physical conditions that would interfere with participation
- excessive pain in any joint that might limit participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanisms and Long-term Effects of Separate vs. Coupled Rehabilitation Approaches After Stroke
Identify the possible mechanisms and the relative effectiveness of existing rehabilitation approaches that target upper extremity deficits of stroke patients on the ground that these approaches are based on neuroplasticity principles and sound motor control theories.
Read the detailed description
Comparisons of constraint-induced therapy (CIT) vs. bilateral arm training (BIT)vs. combined therapy were made. Stroke patients will receive one of these three approaches and be evaluated pre- and post-treatment. the treatment will last 3 weeks and 5 days per week. The evaluation will include clinical measures of motor function, ADL, and quality of life, kinematic performance, and activation patterns of cortex.
- Conditions
- Cerebrovascular Accidents
- Being tested
- Constraint-induced therapy (CIT), Bilateral arm training (BAT), Combined therapy (CT), Control intervention
- Keywords
- stroke rehabilitation, cortical reorganization, kinematic analysis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-induced therapy (CIT)Other
restraint of the unaffected arm and practice of the affected arm
Bilateral arm training (BAT)Other
bilateral symmetric, repetitive arm training
Combined therapy (CT)Other
combined different treatment approaches
Control interventionBehavioural
Conventional treatment program
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | constraint-induced therapy Receives: Other: Constraint-induced therapy (CIT) |
| 2 | Experimental | bilateral arm training Receives: Other: Bilateral arm training (BAT) |
| 3 | Experimental | combined therapy Receives: Other: Combined therapy (CT) |
| Control intervention | Active comparator | Not described Receives: Behavioral: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical reorganization and kinematic analysis
Measured: 2008-2010
Secondary outcomes (1)
clinical measures at the impairment, activity, participation levels
Measured: 2008-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionDec 2010
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 Cerebrovascular AccidentsStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
- Investigators
- Ching-yi Wu, ScD, Principal investigator, Department of Occupational Therapy, Chang Gung Univ.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564005
- Sponsor's protocol ID
- NHRI-EX97-9742PI
- Other IDs
- 96-0252B
- Status last verified
- Sep 2014
- First submitted
- 25 Nov 2007
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wu CY, Chen YA, Lin KC, Chao CP, Chen YT. Constraint-induced therapy with trunk restraint for improving functional outcomes and trunk-arm control after stroke: a randomized controlled trial. Phys Ther. 2012 Apr;92(4):483-92. doi: 10.2522/ptj.20110213. Epub 2012 Jan 6.
PubMed 22228607
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms and Long-term Effects of Separate vs. Coupled Rehabilitation Approaches After Stroke
- ClinicalTrials.gov ID
- NCT00564005
- Acronym / sponsor ID
- NHRI-EX97-9742PI
- Conditions
- Cerebrovascular Accidents
- Keywords
- stroke rehabilitation, cortical reorganization, kinematic analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, National Health Research Institutes, Taiwan
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Nov 2007 (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.
Identify the possible mechanisms and the relative effectiveness of existing rehabilitation approaches that target upper extremity deficits of stroke patients on the ground that these approaches are based on neuroplasticity principles and sound motor control theories.
Detailed description
Comparisons of constraint-induced therapy (CIT) vs. bilateral arm training (BIT)vs. combined therapy were made. Stroke patients will receive one of these three approaches and be evaluated pre- and post-treatment. the treatment will last 3 weeks and 5 days per week. The evaluation will include clinical measures of motor function, ADL, and quality of life, kinematic performance, and activation patterns of cortex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Constraint-induced therapy (CIT)constraint-induced therapy |
| 2 | Experimental | Other: Bilateral arm training (BAT)bilateral arm training |
| 3 | Experimental | Other: Combined therapy (CT)combined therapy |
| Control intervention | Active comparator | Behavioral: Control intervention |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a first-ever clinical cerebrovascular accident patients
- at least 6 months post-stroke onset
- premorbid right-hand dominance
- demonstration of Brunnstrom stage III of the affected upper extremity
- no excessive spasticity in the joints of the affected upper extremity
Key exclusion criteria (3 listed)
- a score of less than 24 on the Mini Mental State Exam
- poor physical conditions that would interfere with participation
- excessive pain in any joint that might limit 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 |
|---|---|---|
| Constraint-induced therapy (CIT)restraint of the unaffected arm and practice of the affected arm | Other | 1 |
| Bilateral arm training (BAT)bilateral symmetric, repetitive arm training | Other | 2 |
| Combined therapy (CT)combined different treatment approaches | Other | 3 |
| Control interventionConventional treatment program | Behavioural | Control intervention |
Primary outcome
Cortical reorganization and kinematic analysis
Time frame: 2008-2010
1 secondary outcome
clinical measures at the impairment, activity, participation levels
Time frame: 2008-2010
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 11 Feb 2015.
- Derived from this study: PubMed 22228607Wu CY, Chen YA, Lin KC, Chao CP, Chen YT. Constraint-induced therapy with trunk restraint for improving functional outcomes and trunk-arm control after stroke: a randomized controlled trial. Phys Ther. 2012 Apr;92(4):483-92. doi: 10.2522/ptj.20110213. Epub 2012 Jan 6.
Related trials for Cerebrovascular Accidents
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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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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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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.
Ching-yi Wu, ScD principal investigator
Department of Occupational Therapy, Chang Gung Univ.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint-induced therapy (CIT), Bilateral arm training (BAT) and Combined therapy (CT) in people with Cerebrovascular Accidents, run by Chang Gung Memorial Hospital at 1 site 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 3 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 11 Feb 2015. 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 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?
Cortical reorganization and kinematic analysis (time frame: 2008-2010). 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 NCT00564005, 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 11 Feb 2015.