Focus on Function Study for Children With Cerebral Palsy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mary Law, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00469872
First received: May 3, 2007
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Cerebral Palsy
Procedure: Context-focused compared to child-focused interventions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family Centred Functional Therapy for Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • activities (performance of functional tasks, motor function) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body function and structure (range of motion) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • particpation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • parental empowerment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: June 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469872

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2G4
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 1C7
Sponsors and Collaborators
Investigators
Principal Investigator: Mary Law, PhD McMaster University
Principal Investigator: Johanna Darrah, PhD University of Alberta
  More Information

No publications provided

Responsible Party: Mary Law, Professor, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00469872     History of Changes
Other Study ID Numbers: R01HD044444
Study First Received: May 3, 2007
Last Updated: September 23, 2014
Health Authority: Canada: Ethics Review Committee
United States: Federal Government

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 30, 2014