Parent Therapist Partnership to Provide Early, Intensive Exercise in Perinatal Stroke (NCT03672864) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Parent Therapist Partnership to Provide Early, Intensive Exercise in Perinatal Stroke
Canada18 participantsStarted 2019-02-15
Plain-language summary
A prospective, single blind, parallel group, randomized control trial to determine if early, intensive lower extremity activity delivered by a physical therapist and a parent in partnership improves gross motor function more than usual care.
Who can participate
Age range
8 Months – 36 Months
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:
* children ages 8 months to 3 years
* medical history and physical exam consistent with perinatal stroke
* hemiparesis in the upper and/or lower extremity
* parental agreement to adhere to the training and testing schedule
Exclusion Criteria:
* bilateral motor impairment
* epileptic seizures that could interfere with training
* cognitive, behavioural or developmental impairments that preclude participation in the protocol
* botulinum toxin A injections or surgery in the lower extremities within the previous six months
* concurrent casting during the intervention phase (including constraint-induced movement therapy with casting)
* diagnosis associated with neurological/developmental regression
* parent unable to communicate (verbal and written) in English or French
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
Gross Motor Function Measure (GMFM-66) - change from baseline