Cerebrovascular AccidentsNCT00778453
Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients
A study testing Hospital-based mCIT, Hospital-based BIT and Hospital-based TR in people with Cerebrovascular Accidents, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The findings of this study will advance movement reorganization mechanism underlying treatment approaches and clinical intervention techniques. These findings may inform rehabilitation professionals about which treatment approach is superior to another one in certain aspect of outcome and who can benefit most from… Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Accidents
- What is being tested?
- Hospital-based mCIT, Hospital-based BIT and Hospital-based TR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2008to Jul 2011
- 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the onset duration more than 6 months
- Brunnstrom stage III above for the proximal part and distal part of UL
- no serious cognitive deficits
- no balance problems sufficient to compromise safety when wearing the project's constraint device
- no excessive spasticity in any of the joints of the affected UL exclusion criteria:
- a score of less than 24 on the Mini Mental State Exam
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients Delivered in Hospital-based and Home-based Settings
The findings of this study will advance movement reorganization mechanism underlying treatment approaches and clinical intervention techniques. These findings may inform rehabilitation professionals about which treatment approach is superior to another one in certain aspect of outcome and who can benefit most from certain treatment approach. Accordingly, the results of this project may help us move quickly to design and develop efficient and effective rehabilitation programs for individualized patients.
Read the detailed description
The first purpose is to investigate the relative effects of modified constraint-induced therapy (mCIT) vs. bilateral isokinematic training (BIT) vs. traditional or therapist-based training (TR) on movement reorganization, motor performance, functional ability, and quality of life (QoL) immediately and six months later after treatment delivered at hospitals. Movement reorganization will be evaluated by kinematic instrument. Motor performance, functional ability, and QoL will be assessed using clinical assessment tools. By the same token, we also investigate the relative effects of these two approaches delivered at home. The second purpose is to study whether home-based mCIT is efficacious in various aspects of outcomes described above immediately and six months later following treatment, compared to home-based TR, and hospital-based mCIT and TR.We also study the same question regarding home-based BIT efficacy. The third purpose is to establish predictive models to predict functional and QoL outcomes immediately and six months later following mCIT and BIT.
- Conditions
- Cerebrovascular Accidents
- Being tested
- Hospital-based mCIT, Hospital-based BIT, Hospital-based TR, Home-based mCIT, Home-based BAT
- Keywords
- stroke rehabilitation, kinematic analysis, upper extremity training, predictors
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital-based mCITOther
Also called Hospital-based modified constraint-induced therapy(mCIT)
restraint of the unaffected arm and practice of the affected arm
Hospital-based BITOther
Also called Hospital-based bilateral isokinematic training (BIT)
bilateral symmetric, repetitive arm training
Hospital-based TROther
Also called Hospital-based traditional rehabilitation (TR)
hospital-based traditional rehabilitation : OT or PT or therapist-based training
Home-based mCITOther
Also called Home-based modified constraint-induced therapy (mCIT)
restraint of the unaffected arm and practices of the affected arm
Home-based BATOther
Also called Home-based bilateral arm training (BAT)
bilateral symmetric, repetitive arm training
Home-based TROther
Also called Home-based traditional rehabilitation (TR)
home-based traditional rehabilitation:OT or PT or therapist-based training
| Study group | Role | What they receive |
|---|---|---|
| Hospital-based mCIT | Experimental | Hospital-based modified constraint-induced therapy(mCIT) Receives: Other: Hospital-based mCIT |
| Hospital-based BIT | Experimental | Hospital-based bilateral isokinematic training (BIT) Receives: Other: Hospital-based BIT |
| Hospital-based TR | Experimental | Hospital-based traditional rehabilitation (TR) Receives: Other: Hospital-based TR |
| Home-based BAT | Experimental | Home-based bilateral arm training(BAT) Receives: Other: Home-based BAT |
| Home-based TR | Experimental | Home-based traditional rehabilitation (TR) Receives: Other: Home-based TR |
| Home-based mCIT | Experimental | Home-based modified constraint-induced therapy (mCIT) Receives: Other: Home-based mCIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
kinematic analysis
Measured: 2008-2011
Secondary outcomes (1)
clinical measures
Measured: 2008-2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2011
- Study completionJul 2011
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
- 150 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
- Principal investigator, Ching-yi Wu, Chang Gung Memorial Hospital
- Investigators
- Ching-yi Wu, ScD, Principal investigator, Department of Occupational Therapy, Chang Gung Univ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778453
- Sponsor's protocol ID
- NSC97-2314-B-182-004-MY3
- Other IDs
- 96-1754B
- Status last verified
- Jul 2012
- First submitted
- 5 Oct 2008
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lin KC, Chuang LL, Wu CY, Hsieh YW, Chang WY. Responsiveness and validity of three dexterous function measures in stroke rehabilitation. J Rehabil Res Dev. 2010;47(6):563-71. doi: 10.1682/jrrd.2009.09.0155.
PubMed 20848369
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients Delivered in Hospital-based and Home-based Settings
- ClinicalTrials.gov ID
- NCT00778453
- Acronym / sponsor ID
- NSC97-2314-B-182-004-MY3
- Conditions
- Cerebrovascular Accidents
- Keywords
- stroke rehabilitation, kinematic analysis, upper extremity training, predictors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 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
- Aug 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Oct 2008 (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 findings of this study will advance movement reorganization mechanism underlying treatment approaches and clinical intervention techniques. These findings may inform rehabilitation professionals about which treatment approach is superior to another one in certain aspect of outcome and who can benefit most from certain treatment approach. Accordingly, the results of this project may help us move quickly to design and develop efficient and effective rehabilitation programs for individualized patients.
Detailed description
The first purpose is to investigate the relative effects of modified constraint-induced therapy (mCIT) vs. bilateral isokinematic training (BIT) vs. traditional or therapist-based training (TR) on movement reorganization, motor performance, functional ability, and quality of life (QoL) immediately and six months later after treatment delivered at hospitals. Movement reorganization will be evaluated by kinematic instrument. Motor performance, functional ability, and QoL will be assessed using clinical assessment tools. By the same token, we also investigate the relative effects of these two approaches delivered at home. The second purpose is to study whether home-based mCIT is efficacious in various aspects of outcomes described above immediately and six months later following treatment, compared to home-based TR, and hospital-based mCIT and TR.We also study the same question regarding home-based BIT efficacy. The third purpose is to establish predictive models to predict functional and QoL outcomes immediately and six months later following mCIT and BIT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Hospital-based mCIT | Experimental | Other: Hospital-based mCITHospital-based modified constraint-induced therapy(mCIT) |
| Hospital-based BIT | Experimental | Other: Hospital-based BITHospital-based bilateral isokinematic training (BIT) |
| Hospital-based TR | Experimental | Other: Hospital-based TRHospital-based traditional rehabilitation (TR) |
| Home-based BAT | Experimental | Other: Home-based BATHome-based bilateral arm training(BAT) |
| Home-based TR | Experimental | Other: Home-based TRHome-based traditional rehabilitation (TR) |
| Home-based mCIT | Experimental | Other: Home-based mCITHome-based modified constraint-induced therapy (mCIT) |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- the onset duration more than 6 months
- Brunnstrom stage III above for the proximal part and distal part of UL
- no serious cognitive deficits
- no balance problems sufficient to compromise safety when wearing the project's constraint device
- no excessive spasticity in any of the joints of the affected UL exclusion criteria:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hospital-based mCITAlso: Hospital-based modified constraint-induced therapy(mCIT)restraint of the unaffected arm and practice of the affected arm | Other | Hospital-based mCIT |
| Hospital-based BITAlso: Hospital-based bilateral isokinematic training (BIT)bilateral symmetric, repetitive arm training | Other | Hospital-based BIT |
| Hospital-based TRAlso: Hospital-based traditional rehabilitation (TR)hospital-based traditional rehabilitation : OT or PT or therapist-based training | Other | Hospital-based TR |
| Home-based mCITAlso: Home-based modified constraint-induced therapy (mCIT)restraint of the unaffected arm and practices of the affected arm | Other | Home-based mCIT |
| Home-based BATAlso: Home-based bilateral arm training (BAT)bilateral symmetric, repetitive arm training | Other | Home-based BAT |
| Home-based TRAlso: Home-based traditional rehabilitation (TR)home-based traditional rehabilitation:OT or PT or therapist-based training | Other | Home-based TR |
Primary outcome
kinematic analysis
Time frame: 2008-2011
1 secondary outcome
clinical measures
Time frame: 2008-2011
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 2 Aug 2012.
- Derived from this study: PubMed 20848369Lin KC, Chuang LL, Wu CY, Hsieh YW, Chang WY. Responsiveness and validity of three dexterous function measures in stroke rehabilitation. J Rehabil Res Dev. 2010;47(6):563-71. doi: 10.1682/jrrd.2009.09.0155.
Related trials for Cerebrovascular Accidents
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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 Hospital-based mCIT, Hospital-based BIT and Hospital-based TR 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 6 inclusion and 0 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 2 Aug 2012. 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?
kinematic analysis (time frame: 2008-2011). 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 NCT00778453, 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 2 Aug 2012.