StrokePhase 2NCT02850042
Comparing Constraint-Induced Therapy and Occupation-Based Intervention for Optimal Stroke Recovery
A Phase 2 study testing Occupation-based practice (OBP) and Modified-constraint induced therapy (m-CIT) in people with Stroke and Cerebrovascular Accident, run by Lumy Sawaki.
Trial summary
This pilot study was designed to compare the effects of modified constraint-Induced therapy and occupation-based intervention to increase functional motor recovery in stroke Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Accident
- What is being tested?
- Occupation-based practice (OBP) and Modified-constraint induced therapy (m-CIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to May 2016
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years of age and older
- at least 12 months from stroke
- mild-to-severe upper extremity motor deficit
- single ischemic or hemorrhagic stroke
Who cannot join
- history of head injury with loss of consciousness
- seizures
- severe alcohol or drug abuse
- psychiatric illness interfering with participation in the study including uncontrolled depression
- cognitive deficits severe enough to preclude informed consent
- ferromagnetic material near the brain
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- individuals that could be pregnant
- cardiac or neural pacemakers
- if currently receiving occupational therapy services
About this study
This pilot study was designed to compare the effects of modified constraint-Induced therapy and occupation-based intervention to increase functional motor recovery in stroke
Read the detailed description
The purpose of this study is to investigate change in motor performance and the extent of neuroplastic change associated with both occupation-based intervention and modified constraint-Induced therapy (m-CIT) in the recovery of upper extremity motor function following a stroke. Transcranial Magnetic Imaging (TMS) will be used to compare the difference in the brain reorganization of each client before and after the intervention to identify which technique is more effective in changing brain function. Central Hypothesis: Stroke subjects with motor deficit receiving occupation-based interventions will demonstrate improved motor function greater to that of the subjects receiving m-CIT interventions. Sixteen participants with chronic stroke will be recruited for the study over the age 21. Participants will be randomly assigned to one of the two therapy groups and will receive 55 minutes of therapy 2 times per week for 4 weeks for a total of 8 sessions.
- Conditions
- Stroke, Cerebrovascular Accident
- Being tested
- Occupation-based practice (OBP), Modified-constraint induced therapy (m-CIT)
- Keywords
- motor recovery, human, occupation-based practice, motor training, transcranial magnetic stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupation-based practice (OBP)Behavioural
Modified-constraint induced therapy (m-CIT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Occupation-based practice | Experimental | Occupation-based intervention (OBP) is a form of activity-based therapy consisting of client-directed occupations that match client-identified goals. OBP group will participate in activities such as wood working, scrap booking, higher level dressing (don/doffing a bra, zipping coat), hair care, opening doors, using bathroom stalls, typing, cooking, tying shoes, washing dishes, carrying dirty dish carts, clearing dirty dishes and raking. Repetition of the tasks are not the focus in the OBP group. Each session lasted 55-minute and it was delivered twice a week for 4 weeks (8 sessions). Receives: Behavioral: Occupation-based practice (OBP) |
| Modified-constraint induced therapy | Active comparator | Modified-constraint induced therapy (m-CIT) group will target functional goals (eg, activities of daily living) or goal subcomponents (eg, pinching, grasp/release, or functional reach patterns). Tasks were repeated at rate of approximately 10 to 50 repetitions each session according to the demands of the task. No physical constraint of the less-affected UE will be applied, but training compelled highly repetitive use of the more-affected upper extremity. Subjects will attempt tasks with progressive difficulty. Each session lasted 55-minute and it was delivered twice a week for 4 weeks (8 sessions). Receives: Behavioral: Modified-constraint induced therapy (m-CIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment (FMA
Measured: Score change after 8 days of intervention compared to baseline
Secondary outcomes (4)
Stroke Impact Scale (SIS)
Measured: Score change after 8 days of intervention compared to baseline
Canadian Occupational Performance Measure (COPM)
Measured: Score change after 8 days of intervention compared to baseline
Goal Attainment Scale (GAS).
Measured: Score change after 8 days of intervention compared to baseline
Transcranial Magnetic Stimulation (map volume)
Measured: Score change after 8 days of intervention compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJun 2013
- Primary completionMay 2016
- Study completionMay 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumy Sawaki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lumy Sawaki, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850042
- Sponsor's protocol ID
- 13-0509
- Status last verified
- Apr 2017
- First submitted
- 27 Jul 2016
- Last updated
- 20 Apr 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 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Constraint-Induced Therapy and Occupation-Based Intervention for Optimal Stroke Recovery
- ClinicalTrials.gov ID
- NCT02850042
- Acronym / sponsor ID
- 13-0509
- Conditions
- Stroke, Cerebrovascular Accident
- Keywords
- motor recovery, human, occupation-based practice, motor training, transcranial magnetic stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Lumy SawakiUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Jul 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.
This pilot study was designed to compare the effects of modified constraint-Induced therapy and occupation-based intervention to increase functional motor recovery in stroke
Detailed description
The purpose of this study is to investigate change in motor performance and the extent of neuroplastic change associated with both occupation-based intervention and modified constraint-Induced therapy (m-CIT) in the recovery of upper extremity motor function following a stroke. Transcranial Magnetic Imaging (TMS) will be used to compare the difference in the brain reorganization of each client before and after the intervention to identify which technique is more effective in changing brain function. Central Hypothesis: Stroke subjects with motor deficit receiving occupation-based interventions will demonstrate improved motor function greater to that of the subjects receiving m-CIT interventions. Sixteen participants with chronic stroke will be recruited for the study over the age 21. Participants will be randomly assigned to one of the two therapy groups and will receive 55 minutes of therapy 2 times per week for 4 weeks for a total of 8 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupation-based practice | Experimental | Behavioral: Occupation-based practice (OBP)Occupation-based intervention (OBP) is a form of activity-based therapy consisting of client-directed occupations that match client-identified goals. OBP group will participate in activities such as wood working, scrap booking, higher level dressing (don/doffing a bra, zipping coat), hair care, opening doors, using bathroom stalls, typing, cooking, tying shoes, washing dishes, carrying dirty dish carts, clearing dirty dishes and raking. Repetition of the tasks are not the focus in the OBP group. Each session lasted 55-minute and it was delivered twice a week for 4 weeks (8 sessions). |
| Modified-constraint induced therapy | Active comparator | Behavioral: Modified-constraint induced therapy (m-CIT)Modified-constraint induced therapy (m-CIT) group will target functional goals (eg, activities of daily living) or goal subcomponents (eg, pinching, grasp/release, or functional reach patterns). Tasks were repeated at rate of approximately 10 to 50 repetitions each session according to the demands of the task. No physical constraint of the less-affected UE will be applied, but training compelled highly repetitive use of the more-affected upper extremity. Subjects will attempt tasks with progressive difficulty. Each session lasted 55-minute and it was delivered twice a week for 4 weeks (8 sessions). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 21 years of age and older
- at least 12 months from stroke
- mild-to-severe upper extremity motor deficit
- single ischemic or hemorrhagic stroke
Key exclusion criteria (9 listed)
- history of head injury with loss of consciousness
- seizures
- severe alcohol or drug abuse
- psychiatric illness interfering with participation in the study including uncontrolled depression
- cognitive deficits severe enough to preclude informed consent
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 |
|---|---|---|
| Occupation-based practice (OBP) | Behavioural | Occupation-based practice |
| Modified-constraint induced therapy (m-CIT) | Behavioural | Modified-constraint induced therapy |
Primary outcome
Fugl Meyer Assessment (FMA
Time frame: Score change after 8 days of intervention compared to baseline
4 secondary outcomes
Stroke Impact Scale (SIS)
Time frame: Score change after 8 days of intervention compared to baseline
Canadian Occupational Performance Measure (COPM)
Time frame: Score change after 8 days of intervention compared to baseline
Goal Attainment Scale (GAS).
Time frame: Score change after 8 days of intervention compared to baseline
Transcranial Magnetic Stimulation (map volume)
Time frame: Score change after 8 days of intervention compared to baseline
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 20 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Occupation-based practice (OBP) and Modified-constraint induced therapy (m-CIT) in people with Stroke and Cerebrovascular Accident, run by Lumy Sawaki.
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 4 inclusion and 9 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 20 Apr 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Meyer Assessment (FMA (time frame: Score change after 8 days of intervention compared to baseline). 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 20 Apr 2017.