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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00430131
• Other study ID #: BKR-06-055
• Status: Active, not recruiting
• Phase: N/A
• First received: January 30, 2007
• Last updated: August 12, 2009
• Start date: December 2006
• Est. completion date: September 2009

Study information

• Verified date: August 2009
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: September 2009
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Procedure:
• Cognitive Orientation to Occupational Performance

• Contemporary Treatment Approach

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	ErinoakKids, Holland Bloorview Kids Rehabilitation Hospital