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Clinical Trial Summary

The On Track Study is a large multi-site collaboration involving researchers, therapists, families, and children with cerebral palsy (CP) from across Canada and the United States. The researchers need to better understand how young children who have difficulties with movement activities progress and develop in their balance abilities, fitness, strength, health, range of motion, self-care, everyday play, and activity participation.

This study will determine how young children with cerebral palsy or gross motor delays progress in many aspects of their physical development and participation in daily life. The information collected from this study will help therapists and parents monitor if a child is developing as expected in his or her physical development and participation. Then, the health care professionals working with children can use the results of this study, in combination with the previously completed Move & PLAY study results, to provide the services that are most beneficial and meaningful for each child and their family members.


Clinical Trial Description

Trained therapist assessors will measure the primary and secondary impairments (i.e., balance, range of motion limitations, and strength) on 5 occasions (6-months apart over 2 years). Parents will complete questionnaires to track changes in the child's endurance, health conditions, and participation in self-care and recreation activities, at the same data collection points. The researchers will use these 5 data collection points to develop reference percentiles and will present the data so that therapists can assist families to determine if children with CP are developing as expected, better than expected, or more poorly than expected, depending on their functional ability levels.

The researchers will create longitudinal developmental curves for impairments, health conditions, and participation variables by estimating the average pattern of change, important individual variations in the pattern of change between children, and the degree of consistency over time within children. Establishment of longitudinal developmental curves will provide easily understood and useful tools for families and service providers to discuss questions about how well their children are doing in relationship to other children with CP of similar functional ability levels. The researchers will then utilize service data collected from parents and children's progress on the longitudinal developmental curves to develop recommendations for rehabilitation service provision for children with CP across functional ability levels. Having this information should assist with collaborative decision-making among family members and service providers that efficiently utilizes rehabilitation services to meet families' goals.

An additional sub-study is to collect direct physical activity measurements from a sub-set of the children in the larger study. These data will be examined in relationship to other measures of endurance and participation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02391948
Study type Observational
Source University of Washington
Contact
Status Completed
Phase
Start date July 1, 2013
Completion date March 31, 2017

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