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Clinical Trials/NCT02850042
NCT02850042
Completed
Phase 2

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

Lumy Sawaki0 sites16 target enrollmentJune 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Stroke
Sponsor
Lumy Sawaki
Enrollment
16
Primary Endpoint
Fugl Meyer Assessment (FMA
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Lumy Sawaki
Responsible Party
Sponsor Investigator
Principal Investigator

Lumy Sawaki

Associate Professor,department of Physical Medicine and Rehabilitation

University of Kentucky

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
  • 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

Outcomes

Primary Outcomes

Fugl Meyer Assessment (FMA

Time Frame: Score change after 8 days of intervention compared to baseline

Secondary Outcomes

  • Canadian Occupational Performance Measure (COPM)(Score change after 8 days of intervention compared to baseline)
  • Stroke Impact Scale (SIS)(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)

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