On Track: Monitoring Development of Children With Cerebral Palsy or Gross Motor Delay (NCT02391948) | Clinical Trial Compass
CompletedNot Applicable
On Track: Monitoring Development of Children With Cerebral Palsy or Gross Motor Delay
United States, Canada724 participantsStarted 2013-07-01
Plain-language 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.
Who can participate
Age range
18 Months – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early Clinical Assessment of Balance (ECAB)
Timeframe: up to 24-months
2
Spinal Alignment and Range of Motion Measure (SAROMM)
Timeframe: up to 24-months
3
Functional Strength Assessment (FSA)
Timeframe: up to 24-months
4
Six and One-minute Walk Test (6MWT, 1MWT)
Timeframe: up to 24-months
5
Early Activity Scale for Endurance (EASE)
Timeframe: up to 24-months
6
Child Health Conditions Questionnaire
Timeframe: up to 24-months
7
Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation
Timeframe: up to 24-months
8
Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care