N/A N=708

On Track: Monitoring Development of Children With Cerebral Palsy or Gross Motor Delay

Cerebral Palsy

Bottom Line

View on ClinicalTrials.gov: NCT02391948 ↗

Enrolled (actual)

708

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: Early Clinical Assessment of Balance (ECAB) — 79.4; 61.1; 38.0; 23.0 units on a scale

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Early Clinical Assessment of Balance (ECAB)	79.4; 61.1; 38.0; 23.0; 7.3; 97.4	—
PRIMARY Spinal Alignment and Range of Motion Measure (SAROMM)	0.3; 0.6; 0.9; 1.1; 1.4; 0.4	—
PRIMARY Functional Strength Assessment (FSA)	4.0; 3.6; 3.1; 2.6; 1.8; 4.5	—
PRIMARY Six and One-minute Walk Test (6MWT, 1MWT)	1080.3; 697.3; 396.2; 1386.2; 1041.8; 616.9	—
PRIMARY Early Activity Scale for Endurance (EASE)	4.0; 3.6; 3.3; 2.7; 1.9; 3.7	—
PRIMARY Child Health Conditions Questionnaire	0.5; 0.9; 0.9; 1.4; 2.1; 0.7	—
PRIMARY Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation	67.0; 65.1; 62.3; 55.8; 54.0; 70.2	—
PRIMARY Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care	54.4; 49.0; 44.4; 33.6; 16.1; 73.0	—
PRIMARY Services Questionnaire	2.2; 2.5; 2.8; 2.9; 2.9; 2.2	—
SECONDARY Percentage of All Participants According to Gross Motor Function Classification System (GMFCS)	32.1; 22.7; 11.3; 18.2; 15.7	—
SECONDARY Manual Ability Classification System (MACS)	95; 33; 12; 4; 0; 121	—
SECONDARY Communication Function Classification System (CFCS)	144; 63; 34; 20; 3; 46	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02391948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.