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
About this trial
This is an interventional treatment trial for Cerebral Palsy
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00430131
First Posted
January 30, 2007
Last Updated
August 12, 2009
Sponsor
University of Toronto
Collaborators
Holland Bloorview Kids Rehabilitation Hospital, ErinoakKids
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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