MedTrace Logo

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

NCT00430131 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2009-08-13

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy

Interventions

PROCEDURE

Cognitive Orientation to Occupational Performance

PROCEDURE

Contemporary Treatment Approach

Sponsors & Collaborators

  • Holland Bloorview Kids Rehabilitation Hospital

    collaborator OTHER

  • ErinoakKids

    collaborator OTHER

  • University of Toronto

    lead OTHER

Principal Investigators

  • Debra L Cameron, PhD. O.T. · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Completion
2009-09-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00430131 on ClinicalTrials.gov