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Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Orientation to Occupational Performance
Contemporary Treatment Approach
Sponsored by
University of Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

7 Years - 12 Years (Child)All Sexes

Inclusion Criteria:

  • between 7 and 12 years of age
  • diagnosis of cerebral palsy with hemiplegia or spastic diplegia
  • Level 1,2 or 3 on the Gross Motor Function Classification Scale(GMFCS)
  • normal intelligence (IQ> 85 on at least one scale (verbal or performance) of the Kaufman Brief Intelligence Test (KBIT-2)
  • child assent and agreement to participate
  • parental consent and agreement to participate
  • sufficient language ability to communicate with and be understood during treatment

Exclusion Criteria:

  • previously received or presently receiving a cognitive treatment for motor-based performance problems
  • use of alternative communication system such as PECS or communication board
  • regular use of BOTOX during intervention period

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 30, 2007
    Last Updated
    August 12, 2009
    Sponsor
    University of Toronto
    Collaborators
    Holland Bloorview Kids Rehabilitation Hospital, ErinoakKids
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00430131
    Brief Title
    Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches
    Official Title
    Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Toronto
    Collaborators
    Holland Bloorview Kids Rehabilitation Hospital, ErinoakKids

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This project (CO-OP II) is the second in a series of three studies to validate a new treatment approach for children with cerebral palsy (CP). The initial study was comprised of a series of four single case studies with children with CP. It evaluated the potential of the Cognitive Orientation to Occupational Performance (CO-OP) approach to be used with children with CP and tested the procedures for CO-OP II. The overall objective of the full series of studies is to determine whether better functional outcomes are achieved for children with CP with CO-OP intervention than with contemporary occupational therapy treatment. The primary objective of CO-OP II is to establish the feasibility of conducting a full scale randomize control trial (RCT) to discover if there are differences in functional outcomes (i.e., improvement in task performance, self efficacy) between a group of children with CP receiving CO-OP therapy and a group receiving a contemporary treatment approach (CTA). In order to meet this objective, a pilot RCT will be conducted to answer the specific research questions outlined below: Do children wiht CP acquire the skills they set as goals in each of the two treatment groups? Do the acquired skills generalize and transfer? Are the skills maintained at 4 months post intervention? Does the CO-OP approach produce a larger effect on skill acquisition and self efficacy than the CTA? Does amount of parent involvement have any effect on skill acquisition or self efficacy? Completion of this pilot RCT will provide the necessary data to conduct a full study to test the following hypothesis: - Children with CP who receive CO-OP treatment will be more successful than children receiving CTA in improving their performance on child-chosen skills and they self efficacy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Cognitive Orientation to Occupational Performance
    Intervention Type
    Procedure
    Intervention Name(s)
    Contemporary Treatment Approach

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    12 Years
    Eligibility Criteria
    Inclusion Criteria: between 7 and 12 years of age diagnosis of cerebral palsy with hemiplegia or spastic diplegia Level 1,2 or 3 on the Gross Motor Function Classification Scale(GMFCS) normal intelligence (IQ> 85 on at least one scale (verbal or performance) of the Kaufman Brief Intelligence Test (KBIT-2) child assent and agreement to participate parental consent and agreement to participate sufficient language ability to communicate with and be understood during treatment Exclusion Criteria: previously received or presently receiving a cognitive treatment for motor-based performance problems use of alternative communication system such as PECS or communication board regular use of BOTOX during intervention period
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Debra L Cameron, PhD. O.T.
    Organizational Affiliation
    University of Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches

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