Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469872
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2007-05-03
Brief Title:
Focus on Function Study for Children With Cerebral Palsy
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Family Centred Functional Therapy for Children With Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs function The two approaches being compared are 1 improving function by working with the child to improve hisher skills and abilities child-focused approach and 2 improving function by changingadapting the task andor environment around the child to improve hisher 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 childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None