Comparing Constraint-Induced Therapy and Occupation-Based Intervention for Optimal Stroke Recovery

Sponsor

Lumy Sawaki (Other)

Overall Status

Completed

CT.gov ID

NCT02850042

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Stroke Cerebrovascular Accident	Behavioral: Occupation-based practice (OBP) Behavioral: Modified-constraint induced therapy (m-CIT)	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparing Constraint-Induced Therapy and Occupation-Based Intervention for Optimal Stroke Recovery

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Occupation-based practice 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)
Active Comparator: Modified-constraint induced therapy 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)

Arm

Intervention/Treatment

Experimental: Occupation-based practice

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)

Active Comparator: Modified-constraint induced therapy

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)

Outcome Measures

Primary Outcome Measures

Fugl Meyer Assessment (FMA [Score change after 8 days of intervention compared to baseline]

Secondary Outcome Measures

Stroke Impact Scale (SIS) [Score change after 8 days of intervention compared to baseline]
Canadian Occupational Performance Measure (COPM) [Score change after 8 days of intervention compared to baseline]
Goal Attainment Scale (GAS). [Score change after 8 days of intervention compared to baseline]
Transcranial Magnetic Stimulation (map volume) [Score change after 8 days of intervention compared to baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

21 years of age and older
at least 12 months from stroke
mild-to-severe upper extremity motor deficit
single ischemic or hemorrhagic stroke

Exclusion Criteria:

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
individuals that could be pregnant
cardiac or neural pacemakers
if currently receiving occupational therapy services