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

Completed

Phase 2 Results N/A

Trial Description

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

Interventions

  • Occupation-based practice (OBP) Behavioral
    ARM 1: Kind: Experimental
    Label: Occupation-based practice
    Description: 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 (m-CIT) Behavioral
    ARM 1: Kind: Experimental
    Label: Modified-constraint induced therapy
    Description: 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).

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl Meyer Assessment (FMA Score change after 8 days of intervention compared to baseline No
Secondary Stroke Impact Scale (SIS) Score change after 8 days of intervention compared to baseline No
Secondary Canadian Occupational Performance Measure (COPM) Score change after 8 days of intervention compared to baseline No
Secondary Goal Attainment Scale (GAS). Score change after 8 days of intervention compared to baseline No
Secondary Transcranial Magnetic Stimulation (map volume) Score change after 8 days of intervention compared to baseline No

Sponsors