Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches
|ClinicalTrials.gov Identifier: NCT00430131|
Recruitment Status : Unknown
Verified August 2009 by University of Toronto.
Recruitment status was: Active, not recruiting
First Posted : February 1, 2007
Last Update Posted : August 13, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Procedure: Cognitive Orientation to Occupational Performance Procedure: Contemporary Treatment Approach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches|
|Study Start Date :||December 2006|
|Estimated Study Completion Date :||September 2009|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430131
|Principal Investigator:||Debra L Cameron, PhD. O.T.||University of Toronto|