Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches
Recruitment status was Active, not recruiting
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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:
- 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 | 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 |
Eligibility| Ages Eligible for Study: | 7 Years to 12 Years |
| Genders Eligible for Study: | Both |
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
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 May 22, 2013