CompletedNot Applicable

Radial Shockwave for Spasticity in Children With CP or ABI

Belgium24 participantsStarted 2024-09-24

Plain-language summary

The goal of this clinical trial is to determine if radial Extracorporeal shockwave therapy (rESWT) reduces spasticity in children with Cerbral Palsy (CP) or traumatic brain injury (TBI). The main questions it aims to answer are: * Is it feasible to implement radial shockwave therapy in conventional physiotherapy plan in children with CP or TBI? * Is it safe and effective to use rESWT for reducing spasticity in children with CP or TBI? Participants will receive a 4 week therapy intervention, as add on to the conventional physio (usual care), including one rESWT session per week for a total of 4 sessions.

Who can participate

Age range

6 Years – 18 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: * cerebral palsy or acquired brain injury * between 6-18 years old; * gross motor function classification ≥2; * experiencing spasticity in the lower limb (calf muscles, hip adductor muscles or hamstring muscles) and/or in the upper limb (biceps muscle, wrist flexor muscles, finger flexor muscles) with Modified Ashworth Scores (MAS) ≥1+. Exclusion Criteria: * recent (≤3 months) Botox injections or other recent (≤6 months) invasive intervention; * local infections or wounds; neuropathy; * severe organ dysfunction; * severe psychosocial dysfunction that would not allow adhering to protocol; * planned changes in medication dosage or medication scheme that might affect spasticity during a 4-month intervention and follow-up phase.

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

Modified Ashworth Scale

Timeframe: Change from baseline to the end of intervention sessions at week 4

Modified Ashworth Scale

Timeframe: Change from baseline to 3 months follow-up

Trial details

NCT IDNCT06909838

SponsorGymna Uniphy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-05

View on ClinicalTrials.gov More Spasticity Due to Cerebral Palsy trials