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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Holland Bloorview Kids Rehabilitation Hospital
ErinoakKids
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00430131
First received: January 30, 2007
Last updated: August 12, 2009
Last verified: August 2009
  Purpose

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 Intervention
Cerebral Palsy
Procedure: Cognitive Orientation to Occupational Performance
Procedure: Contemporary Treatment Approach

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Enrollment: 18
Study Start Date: December 2006
Estimated Study Completion Date: September 2009
  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430131

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

No publications provided

Responsible Party: Debra Cameron, University of Toronto
ClinicalTrials.gov Identifier: NCT00430131     History of Changes
Other Study ID Numbers: BKR-06-055
Study First Received: January 30, 2007
Last Updated: August 12, 2009
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 14, 2014