CompletedPhase 1

Shockwaves Therapy and Botulinum Toxin for the Treatment of Spasticity in Patients With Cerebral Palsy. A Cross Over RCT

Spain70 participantsStarted 2014-09

Plain-language summary

Spasticity is a motor disorder that can affect the lower limbs in up to 75% patients with cerebral palsy, having a significantly effect on their mobility and quality of life. There is much controversy about what is the most appropriate treatment of spasticity The objective of the present study is to evaluate the effects of radial extracorporeal shock wave therapy (rESWT) compared to treatment with botulinum toxin to improve spasticity in patients with cerebral palsy The number needed of patients is 70 (35 per group). Leaving a period of washout between one therapy and the other

Who can participate

Age range

5 Years – 55 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: * Age between 5 and 55 years * Any level of GMFCS (Gross Motor Function Classification System) * The patient consent to participate in the study * Diagnosis of spastic cerebral palsy * Triceps Surae spasticity in them. * The dynamic foot deformity. * Extensibility between 0 ° and 20 ° in dorsal flexion passive way. * Do not be diagnosed important cutaneous alterations. Exclusion Criteria: * Associate neuromuscular disease. * Surgical Intervention to augment the balance articulate and / or reduce the spasticity in the last six months. * Fixed foot deformity. * Etiology of factors: or genetic bone disorders / disturbances soft parts. Position with anomalies or alterations in soft parts or bone alterations (mechanical). * Unable to follow the treatment. * Allergy to botulinum toxin.

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

muscle elongation of spastic muscle will be evaluated using composite measure of muscular extensibility and their traction reflex with goniometry

Timeframe: up to three months

Trial details

NCT IDNCT02400619

SponsorXavi Vidal Novellas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

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