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Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training

Primary Purpose

Stroke

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modified Constraint-Induced Movement therapy
Task-specific bimanual training
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, arm paresis, mCIMT, bimanual training, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Upper extremity hemiparesis
  • Between 2 and 16 weeks post-stroke
  • At least 10º active extension of the wrist and at least 10º active extension of the thumb and at least 2 additional fingers

Exclusion Criteria:

  • Cognitive problems, Mini Mental Status < 24
  • Excessive pain in the paretic extremity
  • Major medical problems

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1. Modified Constraint-Induced Movement therapy

    2.Task-specific bimanual training

    Arm Description

    Modified Constraint-Induced Movement Therapy at the rehabilitation unit or in an outpatient clinic.

    Task-specific bimanual training at the rehabilitation unit or in an outpatient clinic.

    Outcomes

    Primary Outcome Measures

    Action Reach Arm Test

    Secondary Outcome Measures

    Motor Activity Log

    Full Information

    First Posted
    February 23, 2009
    Last Updated
    January 3, 2014
    Sponsor
    University of Bergen
    Collaborators
    Haukeland University Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00851123
    Brief Title
    Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training
    Official Title
    Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training for Subacute Stroke Patients. A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Terminated
    Why Stopped
    Due to recruitment difficulties the trial was stopped after an interim analysis at 30 patients.
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Bergen
    Collaborators
    Haukeland University Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to evaluate the benefit of two different treatment approaches for the hemiplegic arm, modified Constraint-Induced Movement Therapy and task-related bimanual training.
    Detailed Description
    Detailed description: Constrained-Induced Movement Therapy seems to be an efficacious treatment approach for a certain subgroup of patients with moderate to mild hemiparesis after stroke. Still it remains unclear whether the training intensity or restriction of the better arm plays the bigger role. CIMT or mCIMT is usually compared to standard care of lower intensity with no constraint of the better arm, or other treatments that do not focus on functional (task-specific) training for the hemiplegic arm. Bimanual training, implying training of activities requiring use of both arms, may however, be even more effective than mCIMT, provided that the training is of similar intensity. The purposes of this study are: To compare the functional effect of mCIMT to bimanual training of equal intensity in order to examine if one of the treatment approaches is superior to the other regarding the regaining of motor abilities. Based on fMRI scans of a subgroup of patients, to examine whether cortical reorganization after stroke differs depending on the type of treatment received (mCIMT vs bimanual training). To examine the rationale for implementing new treatment approaches in primary- and secondary health care, and thereby contribute to improved coordination between specialist and municipal health care systems. Patients in both groups will participate in a 4 week training program, either mCIMT or bimanual. In both groups cognitive techniques will be used to increase adherence. The patients will be examined when screening, before and after the intervention, and 3 months after completed intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Stroke, arm paresis, mCIMT, bimanual training, rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1. Modified Constraint-Induced Movement therapy
    Arm Type
    Experimental
    Arm Description
    Modified Constraint-Induced Movement Therapy at the rehabilitation unit or in an outpatient clinic.
    Arm Title
    2.Task-specific bimanual training
    Arm Type
    Experimental
    Arm Description
    Task-specific bimanual training at the rehabilitation unit or in an outpatient clinic.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Modified Constraint-Induced Movement therapy
    Intervention Description
    Four hours of treatment a week for four weeks by a physiotherapist or an occupational therapist emphasizing the affected arm. Patients will receive an individually tailored home training program and are supposed to train 2-3 hours daily on their own. A restraining mitt has to be worn 5 hours a day.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Task-specific bimanual training
    Intervention Description
    Four hours of treatment a week for four weeks by a physiotherapist or an occupational therapist emphasizing bimanual tasks. Patients will receive an individually tailored home training program and are supposed to train 2-3 hours daily on their own.
    Primary Outcome Measure Information:
    Title
    Action Reach Arm Test
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Motor Activity Log
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Upper extremity hemiparesis Between 2 and 16 weeks post-stroke At least 10º active extension of the wrist and at least 10º active extension of the thumb and at least 2 additional fingers Exclusion Criteria: Cognitive problems, Mini Mental Status < 24 Excessive pain in the paretic extremity Major medical problems
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Iris C. Brunner, MSc
    Organizational Affiliation
    University of Bergen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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