NCT Number: NCT00469872
Focus on Function Study 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.
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Notify MeKey information
Conditions
Age range
12 month–5 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
University of Alberta, Edmonton, Alberta, Canada
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
activities (performance of functional tasks, motor function)
Time frame: 6 months
Secondary outcomes
-
body function and structure (range of motion)
Time frame: 6 months
-
particpation
Time frame: 6 months
-
parental empowerment
Time frame: 6 months
Sponsors and collaborators
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nih
Collaborators
- National Institutes of Health (NIH)
Registry information
Official study title
Family Centred Functional Therapy for Children With Cerebral Palsy
Important dates
- Study start
- 2006
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- May 7, 2007
- Registry last updated
- Sep 25, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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