StrokeNCT00851123
Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training
A study testing Modified Constraint-Induced Movement therapy and Task-specific bimanual training in people with Stroke, run by University of Bergen.
Trial summary
The purpose of the study is to evaluate the benefit of two different treatment approaches for the hemiplegic arm, modified Constraint-Induced Movement Therapy and task-related bimanual training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Modified Constraint-Induced Movement therapy and Task-specific bimanual training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Jan 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Upper extremity hemiparesis
- Between 2 and 16 weeks post-stroke
- At least 10º active extension of the wrist and at least 10º active extension of the thumb and at least 2 additional fingers
Who cannot join
- Cognitive problems, Mini Mental Status < 24
- Excessive pain in the paretic extremity
- Major medical problems
About this study
Official title: Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training for Subacute Stroke Patients. A Randomized Controlled Trial
The purpose of the study is to evaluate the benefit of two different treatment approaches for the hemiplegic arm, modified Constraint-Induced Movement Therapy and task-related bimanual training.
Read the detailed description
Detailed description:
Constrained-Induced Movement Therapy seems to be an efficacious treatment approach for a certain subgroup of patients with moderate to mild hemiparesis after stroke. Still it remains unclear whether the training intensity or restriction of the better arm plays the bigger role. CIMT or mCIMT is usually compared to standard care of lower intensity with no constraint of the better arm, or other treatments that do not focus on functional (task-specific) training for the hemiplegic arm. Bimanual training, implying training of activities requiring use of both arms, may however, be even more effective than mCIMT, provided that the training is of similar intensity. The purposes of this study are:
- To compare the functional effect of mCIMT to bimanual training of equal intensity in order to examine if one of the treatment approaches is superior to the other regarding the regaining of motor abilities.
- Based on fMRI scans of a subgroup of patients, to examine whether cortical reorganization after stroke differs depending on the type of treatment received (mCIMT vs bimanual training).
- To examine the rationale for implementing new treatment approaches in primary- and secondary health care, and thereby contribute to improved coordination between specialist and municipal health care systems.
Patients in both groups will participate in a 4 week training program, either mCIMT or bimanual. In both groups cognitive techniques will be used to increase adherence. The patients will be examined when screening, before and after the intervention, and 3 months after completed intervention.
- Conditions
- Stroke
- Being tested
- Modified Constraint-Induced Movement therapy, Task-specific bimanual training
- Keywords
- Stroke, arm paresis, mCIMT, bimanual training, rehabilitation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Constraint-Induced Movement therapyBehavioural
Four hours of treatment a week for four weeks by a physiotherapist or an occupational therapist emphasizing the affected arm. Patients will receive an individually tailored home training program and are supposed to train 2-3 hours daily on their own. A restraining mitt has to be worn 5 hours a day.
Task-specific bimanual trainingBehavioural
Four hours of treatment a week for four weeks by a physiotherapist or an occupational therapist emphasizing bimanual tasks. Patients will receive an individually tailored home training program and are supposed to train 2-3 hours daily on their own.
| Study group | Role | What they receive |
|---|---|---|
| 1. Modified Constraint-Induced Movement therapy | Experimental | Modified Constraint-Induced Movement Therapy at the rehabilitation unit or in an outpatient clinic. Receives: Behavioral: Modified Constraint-Induced Movement therapy |
| 2.Task-specific bimanual training | Experimental | Task-specific bimanual training at the rehabilitation unit or in an outpatient clinic. Receives: Behavioral: Task-specific bimanual training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Reach Arm Test
Measured: 3 years
Secondary outcomes (1)
Motor Activity Log
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2011
- Study completionJan 2012
Why it stopped: Due to recruitment difficulties the trial was stopped after an interim analysis at 30 patients.
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Principal investigator, Iris Ch. Brunner, University of Bergen
- Investigators
- Iris C. Brunner, MSc, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851123
- Sponsor's protocol ID
- UiB24126
- Status last verified
- Jan 2014
- First submitted
- 23 Feb 2009
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training for Subacute Stroke Patients. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00851123
- Acronym / sponsor ID
- UiB24126
- Conditions
- Stroke
- Keywords
- Stroke, arm paresis, mCIMT, bimanual training, rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to recruitment difficulties the trial was stopped after an interim analysis at 30 patients.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Feb 2009 (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 the study is to evaluate the benefit of two different treatment approaches for the hemiplegic arm, modified Constraint-Induced Movement Therapy and task-related bimanual training.
Detailed description
Detailed description:
Constrained-Induced Movement Therapy seems to be an efficacious treatment approach for a certain subgroup of patients with moderate to mild hemiparesis after stroke. Still it remains unclear whether the training intensity or restriction of the better arm plays the bigger role. CIMT or mCIMT is usually compared to standard care of lower intensity with no constraint of the better arm, or other treatments that do not focus on functional (task-specific) training for the hemiplegic arm. Bimanual training, implying training of activities requiring use of both arms, may however, be even more effective than mCIMT, provided that the training is of similar intensity. The purposes of this study are:
- To compare the functional effect of mCIMT to bimanual training of equal intensity in order to examine if one of the treatment approaches is superior to the other regarding the regaining of motor abilities.
- Based on fMRI scans of a subgroup of patients, to examine whether cortical reorganization after stroke differs depending on the type of treatment received (mCIMT vs bimanual training).
- To examine the rationale for implementing new treatment approaches in primary- and secondary health care, and thereby contribute to improved coordination between specialist and municipal health care systems.
Patients in both groups will participate in a 4 week training program, either mCIMT or bimanual. In both groups cognitive techniques will be used to increase adherence. The patients will be examined when screening, before and after the intervention, and 3 months after completed intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Modified Constraint-Induced Movement therapy | Experimental | Behavioral: Modified Constraint-Induced Movement therapyModified Constraint-Induced Movement Therapy at the rehabilitation unit or in an outpatient clinic. |
| 2.Task-specific bimanual training | Experimental | Behavioral: Task-specific bimanual trainingTask-specific bimanual training at the rehabilitation unit or in an outpatient clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Upper extremity hemiparesis
- Between 2 and 16 weeks post-stroke
- At least 10º active extension of the wrist and at least 10º active extension of the thumb and at least 2 additional fingers
Key exclusion criteria (3 listed)
- Cognitive problems, Mini Mental Status < 24
- Excessive pain in the paretic extremity
- Major medical problems
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 |
|---|---|---|
| Modified Constraint-Induced Movement therapyFour hours of treatment a week for four weeks by a physiotherapist or an occupational therapist emphasizing the affected arm. Patients will receive an individually tailored home training program and are supposed to train 2-3 hours daily on their own. A restraining mitt has to be worn 5 hours a day. | Behavioural | 1. Modified Constraint-Induced Movement therapy |
| Task-specific bimanual trainingFour hours of treatment a week for four weeks by a physiotherapist or an occupational therapist emphasizing bimanual tasks. Patients will receive an individually tailored home training program and are supposed to train 2-3 hours daily on their own. | Behavioural | 2.Task-specific bimanual training |
Primary outcome
Action Reach Arm Test
Time frame: 3 years
1 secondary outcome
Motor Activity Log
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Due to recruitment difficulties the trial was stopped after an interim analysis at 30 patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
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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.
Iris C. Brunner, MSc principal investigator
University of Bergen
Questions about this trial
What is this clinical trial studying?
A study testing Modified Constraint-Induced Movement therapy and Task-specific bimanual training in people with Stroke, run by University of Bergen.
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 3 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: stopped early, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Due to recruitment difficulties the trial was stopped after an interim analysis at 30 patients.). Results are not available in the source record.
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?
Action Reach Arm Test (time frame: 3 years). 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 6 Jan 2014.