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

L

Lumy Sawaki

Status and phase

Completed
Phase 2

Conditions

Cerebrovascular Accident
Stroke

Treatments

Behavioral: Occupation-based practice (OBP)
Behavioral: Modified-constraint induced therapy (m-CIT)

Study type

Interventional

Funder types

Other

Identifiers

NCT02850042
13-0509

Details and patient eligibility

About

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

Full 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.

Enrollment

16 patients

Sex

All

Ages

21+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

16 participants in 2 patient groups

Occupation-based practice
Experimental group
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).
Treatment:
Behavioral: Occupation-based practice (OBP)
Modified-constraint induced therapy
Active Comparator group
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).
Treatment:
Behavioral: Modified-constraint induced therapy (m-CIT)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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