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

NCT ID: NCT02850042

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-05-31

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Occupation-based practice (OBP)

Intervention Type: BEHAVIORAL

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).

Group Type: ACTIVE_COMPARATOR

Modified-constraint induced therapy (m-CIT)

Intervention Type: BEHAVIORAL

Interventions

Occupation-based practice (OBP)

Intervention Type: BEHAVIORAL

Modified-constraint induced therapy (m-CIT)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumy Sawaki

OTHER

Sponsor Role: lead

Responsible Party

Lumy Sawaki

Associate Professor,department of Physical Medicine and Rehabilitation

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

13-0509

Identifier Type: -

Identifier Source: org_study_id