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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Holland Bloorview Kids Rehabilitation Hospital
Information provided by:
University of Toronto

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:

  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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00430131

Sponsors and Collaborators
University of Toronto
Holland Bloorview Kids Rehabilitation Hospital
Principal Investigator: Debra L Cameron, PhD. O.T. University of Toronto

Responsible Party: Debra Cameron, University of Toronto Identifier: NCT00430131     History of Changes
Other Study ID Numbers: BKR-06-055
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: August 13, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases