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

Primary Purpose

Stroke, Cerebrovascular Accident

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Occupation-based practice (OBP)
Modified-constraint induced therapy (m-CIT)
Sponsored by
Lumy Sawaki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring motor recovery, human, occupation-based practice, motor training, transcranial magnetic stimulation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Occupation-based practice

    Modified-constraint induced therapy

    Arm 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) 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).

    Outcomes

    Primary Outcome Measures

    Fugl Meyer Assessment (FMA

    Secondary Outcome Measures

    Stroke Impact Scale (SIS)
    Canadian Occupational Performance Measure (COPM)
    Goal Attainment Scale (GAS).
    Transcranial Magnetic Stimulation (map volume)

    Full Information

    First Posted
    July 27, 2016
    Last Updated
    April 18, 2017
    Sponsor
    Lumy Sawaki
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02850042
    Brief Title
    Comparing Constraint-Induced Therapy and Occupation-Based Intervention for Optimal Stroke Recovery
    Official Title
    Comparing Constraint-Induced Therapy and Occupation-Based Intervention for Optimal Stroke Recovery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Lumy Sawaki

    4. Oversight

    Data Monitoring Committee
    No

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Cerebrovascular Accident
    Keywords
    motor recovery, human, occupation-based practice, motor training, transcranial magnetic stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Occupation-based practice
    Arm Type
    Experimental
    Arm 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).
    Arm Title
    Modified-constraint induced therapy
    Arm Type
    Active Comparator
    Arm 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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Occupation-based practice (OBP)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Modified-constraint induced therapy (m-CIT)
    Primary Outcome Measure Information:
    Title
    Fugl Meyer Assessment (FMA
    Time Frame
    Score change after 8 days of intervention compared to baseline
    Secondary Outcome Measure Information:
    Title
    Stroke Impact Scale (SIS)
    Time Frame
    Score change after 8 days of intervention compared to baseline
    Title
    Canadian Occupational Performance Measure (COPM)
    Time Frame
    Score change after 8 days of intervention compared to baseline
    Title
    Goal Attainment Scale (GAS).
    Time Frame
    Score change after 8 days of intervention compared to baseline
    Title
    Transcranial Magnetic Stimulation (map volume)
    Time Frame
    Score change after 8 days of intervention compared to baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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