A Phase 2 interventional study of Occupation-based practice (OBP) and Modified-constraint induced therapy (m-CIT) in Stroke and Cerebrovascular Accident, sponsored by Lumy Sawaki. Completed. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-04-20.
Sponsored by Lumy Sawaki · Phase 2, Interventional, and Treatment
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
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 16 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Lumy Sawaki is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Behavioral: Occupation-based practice (OBP)
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).
Behavioral: Modified-constraint induced therapy (m-CIT)
Fugl Meyer Assessment (FMA
Time frame: Score change after 8 days of intervention compared to baseline
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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