This trial is active, not recruiting.

Condition cerebral palsy
Sponsor University of Washington
Collaborator Patient-Centered Outcomes Research Institute
Start date July 2013
End date August 2016
Trial size 600 participants
Trial identifier NCT02391948, 43611-B


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Early Clinical Assessment of Balance (ECAB)
time frame: up to 24-months
Spinal Alignment and Range of Motion Measure (SAROMM)
time frame: up to 24-months
Functional Strength Assessment (FSA)
time frame: up to 24-months
One to Six-minute Walk Test (1MWT, 6MWT)
time frame: up to 24-months
Early Activity Scale for Endurance (EASE)
time frame: up to 24-months
Health Conditions Questionnaire
time frame: up to 24-months
Child Engagement in Daily Life Measure
time frame: up to 24-months
Services Questionnaire
time frame: up to 24-months

Secondary Outcomes

Gross Motor Function Classification System (GMFCS)
time frame: up to 24-months
Manual Ability Classification System (MACS)
time frame: up to 24-months
Communication Function Classification System (CFCS)
time frame: up to 24-months

Eligibility Criteria

Male or female participants from 18 months up to 11 years old.

Inclusion Criteria: Families with a child who has a diagnosis of cerebral palsy or delayed motor development with muscle stiffness and difficulties with balance and moving. Certain geographical areas of Canada and the US. Exclusion Criteria: Children will be excluded if they have: 1) Diagnosis other than cerebral palsy (such as autism, Down syndrome, spinal cord injury, acute head injury, muscle disorder, developmental syndrome, genetic disorder); 2) Gross motor delay without associated problems with muscle tone, balance, and active movement; 3) are wards of the state; and 4) Families who do not speak English, French, or Spanish will not be eligible to participate in this study.

Additional Information

Official title Developmental Trajectories of Impairments, Health, and Participation of Children With Cerebral Palsy
Principal investigator Sarah Westcott McCoy, PhD, PT
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Washington.