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

Cerebral Palsy Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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:

1. Do children wiht CP acquire the skills they set as goals in each of the two treatment groups?

2. Do the acquired skills generalize and transfer?

3. Are the skills maintained at 4 months post intervention?

4. Does the CO-OP approach produce a larger effect on skill acquisition and self efficacy than the CTA?

5. 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

• NCT number: NCT00430131
• Study type: Interventional
• Source: University of Toronto
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2006
• Completion date: September 2009