Focus on Function Study for Children With Cerebral Palsy

NCT ID: NCT00469872

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-01-31

Brief 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.

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Child Focused

Occupational and physical therapy focused on improving child's skills and abilities through rehabilitation to improve child functioning

Group Type: ACTIVE_COMPARATOR

Context-focused compared to child-focused interventions

Intervention Type: PROCEDURE

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

Group Type: EXPERIMENTAL

Context-focused compared to child-focused interventions

Intervention Type: PROCEDURE

Interventions

Context-focused compared to child-focused interventions

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: lead

Responsible Party

Mary Law

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Law, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Johanna Darrah, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 17900362 (View on PubMed)

Other Identifiers

R01HD044444

Identifier Type: NIH

Identifier Source: org_study_id

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