search
Back to results

Focus on Function Study for Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Context-focused compared to child-focused interventions
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

12 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta
  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Child Focused

Context Focused

Arm Description

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

Occupational and physical therapy focused on improving child's skills and abilities through rehabilitation to change the task or environment around a child

Outcomes

Primary Outcome Measures

activities (performance of functional tasks, motor function)

Secondary Outcome Measures

body function and structure (range of motion)
particpation
parental empowerment

Full Information

First Posted
May 3, 2007
Last Updated
September 23, 2014
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
National Institutes of Health (NIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00469872
Brief Title
Focus on Function Study for Children With Cerebral Palsy
Official Title
Family Centred Functional Therapy for Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child Focused
Arm Type
Active Comparator
Arm Description
Occupational and physical therapy focused on improving child's skills and abilities through rehabilitation to improve child functioning
Arm Title
Context Focused
Arm Type
Experimental
Arm Description
Occupational and physical therapy focused on improving child's skills and abilities through rehabilitation to change the task or environment around a child
Intervention Type
Procedure
Intervention Name(s)
Context-focused compared to child-focused interventions
Primary Outcome Measure Information:
Title
activities (performance of functional tasks, motor function)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
body function and structure (range of motion)
Time Frame
6 months
Title
particpation
Time Frame
6 months
Title
parental empowerment
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Law, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johanna Darrah, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G4
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1C7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17900362
Citation
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.
Results Reference
derived

Learn more about this trial

Focus on Function Study for Children With Cerebral Palsy

We'll reach out to this number within 24 hrs