Focus on Function Study for Children With Cerebral Palsy

Family Centred Functional Therapy for Children With Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Procedure: Context-focused compared to child-focused interventions

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2G4
      • University of Alberta
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1C7
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Child Focused; Occupational and physical therapy focused on improving child's skills and abilities through rehabilitation to improve child functioning	Procedure: Context-focused compared to child-focused interventions
Experimental: Context Focused; Occupational and physical therapy focused on improving child's skills and abilities through rehabilitation to change the task or environment around a child	Procedure: Context-focused compared to child-focused interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
activities (performance of functional tasks, motor function)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
body function and structure (range of motion)	6 months
particpation	6 months
parental empowerment	6 months

Collaborators and Investigators

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Mary Law, PhD, McMaster University; Principal Investigator: Johanna Darrah, PhD, University of Alberta

Publications and helpful links

General Publications

• Law M, Darrah J, Pollock N, Rosenbaum P, Russell D, Walter SD, Petrenchik T, Wilson B, Wright V. Focus on Function - a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy. BMC Pediatr. 2007 Sep 27;7:31. doi: 10.1186/1471-2431-7-31.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: May 3, 2007
• First Submitted That Met QC Criteria: May 3, 2007
• First Posted (Estimate): May 7, 2007

Study Record Updates

• Last Update Posted (Estimate): September 25, 2014
• Last Update Submitted That Met QC Criteria: September 23, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: R01HD044444 (U.S. NIH Grant/Contract)