Focus on Function Study for Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Family Centred Functional Therapy for Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469872
• Other study ID #: R01HD044444
• Status: Completed
• Phase: N/A
• First received: May 3, 2007
• Last updated: September 23, 2014
• Start date: June 2006
• Est. completion date: January 2009

Study information

• Verified date: September 2014
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will compare two treatment approaches that are currently being used for children with cerebral palsy. Both treatments aim to improve a child's function. The two approaches being compared are: 1) improving function by working with the child to improve his/her skills and abilities ("child-focused" approach) and 2) improving function by changing/adapting the task and/or environment around the child to improve his/her skills and abilities ("context-focused" approach). It is hypothesized that the context-focused approach will significantly improve activity and participation outcomes while leading to no significant decreases in body function and structure outcomes.

Description:

Children with cerebral palsy commonly receive ongoing physical and occupational therapy to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. The primary objective of this project is to conduct a multi-site clinical trial to evaluate the efficacy of a context-focused approach in improving performance of functional tasks, mobility, participation in everyday activities and quality of life in 220 children 12 months to 5 years of age who have cerebral palsy. A randomized clinical trial research design will be used to examine the efficacy of the context-focused approach compared to a child-focused approach. 72 therapists in Ontario and Alberta will be randomly assigned to provide either context-focused or child-focused therapy. Therapists in both groups will participate in a training workshop and expert consultants will be available to support the therapists throughout the study. Children will receive either the context-focused or child-focused therapy intervention for a period of 6 months. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes will be measured across the domains of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion, spinal alignment), activities (performance of functional tasks, motor function), participation (involvement in formal and informal activities), and environment (parent perceptions of care, parental empowerment). The children's range of motion will also be evaluated by an independent, trained evaluator at baseline, 3, 6, and 9 months. We hypothesize that the context-focused approach will significantly improve activity and participation outcomes while leading to no significant decreases in body function and structure outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 5 Years

Eligibility

Inclusion Criteria:

• children with cerebral palsy

• children classified as levels I-V on the Gross Motor Function Classification System

• children aged 12 months to 5 years, 11 months

Exclusion Criteria:

• children whose parents feel uncomfortable or unable to respond to interviews and questionnaires in English

• children with planned surgical or medication changes during the study period that may impact motor function

• parents and caregivers who state that they will not be able to comply with the treatment schedule

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Procedure:
• Context-focused compared to child-focused interventions

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	National Institutes of Health (NIH)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	activities (performance of functional tasks, motor function)		6 months	No
Secondary	body function and structure (range of motion)		6 months	Yes
Secondary	particpation		6 months	No
Secondary	parental empowerment		6 months	No