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CompletedNCT00469872Updated Sep 25, 2014

Focus on Function Study for Children With Cerebral Palsy

An interventional study of Context-focused compared to child-focused interventions in Cerebral Palsy, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 2 sites in Canada. Open to participants aged 12 Months to 5 Years. Per ClinicalTrials.gov, last updated 2014-09-25.

Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
12 Months to 5 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cerebral Palsy

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03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 128 is above the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureContext-focused compared to child-focused interventions
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What researchers measure

Primary outcomes

  1. activities (performance of functional tasks, motor function)

    Time frame: 6 months

Secondary outcomes

  1. body function and structure (range of motion)

    Time frame: 6 months

  2. particpation

    Time frame: 6 months

  3. parental empowerment

    Time frame: 6 months

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Study locations

2 sites
  • University of Alberta
    Edmonton, Alberta T6G 2G4, Canada
  • McMaster University
    Hamilton, Ontario L8S 1C7, Canada
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References and documents

Publications

  • 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. PubMed 17900362 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00469872
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
National Institutes of Health (NIH)
Responsible party
Mary Law (Professor, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)) — Principal investigator
First posted
May 7, 2007
Start date
Jun 2006
Primary completion
Jan 2009
Completion
Jan 2009
Last update
Sep 25, 2014

Study contacts

Mary Law, PhD
principal investigator · McMaster University
Johanna Darrah, PhD
principal investigator · University of Alberta

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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