Clinical trial NCT02391948: On Track: Monitoring Development of Children With Cerebral Palsy or Gross Motor Delay
Official title: Developmental Trajectories of Impairments, Health, and Participation of Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Gross motor delay
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-03-18
Enrollment: 724
Sex: ALL
Minimum age (years): 18
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with cerebral palsy or gross motor delay and CP motor symptoms, ages 18 month to 12 years, and their parents.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Early Clinical Assessment of Balance (ECAB)
timeFrame: up to 24-months
measure: Spinal Alignment and Range of Motion Measure (SAROMM)
timeFrame: up to 24-months
measure: Functional Strength Assessment (FSA)
timeFrame: up to 24-months
measure: Six and One-minute Walk Test (6MWT, 1MWT)
timeFrame: up to 24-months
measure: Early Activity Scale for Endurance (EASE)
timeFrame: up to 24-months
measure: Child Health Conditions Questionnaire
timeFrame: up to 24-months
measure: Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation
timeFrame: up to 24-months
measure: Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care
timeFrame: up to 24-months
measure: Services Questionnaire
timeFrame: up to 24-months
Secondary outcomes:
measure: Percentage of All Participants According to Gross Motor Function Classification System (GMFCS)
timeFrame: Baseline
measure: Manual Ability Classification System (MACS)
timeFrame: Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)
measure: Communication Function Classification System (CFCS)
timeFrame: Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)
Other outcomes:
measure: Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides)
timeFrame: up to 24-months
measure: Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day
timeFrame: up to 24-months
measure: Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity
timeFrame: up to 24-months
measure: Physical Activity Measurement: Actigraph: Average Physical Activity
timeFrame: up to 24-months
measure: 1 Minute to 6 Minute Push Test (1MPT, 6MPT)
timeFrame: up to 24-months
measure: 1 Stroke Push Test (1SPT)
timeFrame: up to 24-months
measure: Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)
timeFrame: up to 24-months
Locations:
city: Atlanta
country: United States
facility: Mercer University
state: Georgia
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
Study officials:
affiliation: University of Washington
name: Sarah Westcott McCoy, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: