WBV and Serial Casting for Children With Cerebral Palsy (NCT06693388) | Clinical Trial Compass
RecruitingNot Applicable
WBV and Serial Casting for Children With Cerebral Palsy
United States45 participantsStarted 2024-11-11
Plain-language summary
Children with cerebral palsy have increased muscle tone which often results in decreased active and passive movement at the ankle. While many management strategies exist (including passive stretching, WBV, serial casting, Botox, and surgical tendon lengthening), the utilization of WBV in combination with active exercises and serial casting has not been previously explored. Serial casting is the repeated application of a fiberglass cast (such as that applied to manage stable fractures) on a scheduled (usually weekly basis) to gradually increase the range of motion at a specific joint. It is theorized that combining previously established standard of care practices may result in more rapid clinical change, and hence reduce the need for prolonged intervention; ultimately reducing healthcare costs.
Who can participate
Age range
3 Years – 17 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:
* Ages 3-17 and 32 weeks exclusive years;
* Diagnosis of cerebral palsy;
* GMFCS levels I-III;
* Stands with upper extremity support or less support;
* Active referral from a prescribing provider for serial casting with ankle DF of \<10 degrees;
* Willing to pursue care at \[primary site\] outpatient physical therapy clinic for the duration of the study;
* Subjects/families must be able to communicate in the English language without the need for interpreter.
Exclusion Criteria:
* History of selective dorsal rhizotomy;
* previous Achilles tendon lengthening or other orthopedic interventions to the lower extremities in 1 year prior to enrollment;
* skin, circulation, vascular conditions;
* Previous history of cancer;
* Reduced ankle/foot sensation;
* Allergies to casting materials.
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
Ankle Dorsiflexion Range of Motion (Goniometer)
Timeframe: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks