Focus on Function Study for Children With Cerebral Palsy

NCT00469872 | Completed DMC

• 1 other identifier: R01HD044444
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• activities (performance of functional tasks, motor function)

  6 months

Secondary Outcomes (3)

• body function and structure (range of motion)

  6 months

• particpation

  6 months

• parental empowerment

  6 months

Study Arms (2)

Child Focused

ACTIVE COMPARATOR

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

Context Focused

EXPERIMENTAL

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

Context-focused compared to child-focused interventions PROCEDURE

Child Focused; Context Focused

Eligibility Criteria

• Age: 12 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

Location

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Location

Related Publications (1)

• 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.

  PMID: 17900362 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mary Law, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Johanna Darrah, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: June 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

CA (2)