CompletedNot Applicable

Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy

Spain73 participantsStarted 2021-06-10

Plain-language summary

Spasticity is the most common motor disorder in cerebral palsy (CP). The objectives of his therapeutic approach include; reducing pain, ease of use of orthopedic aids, improving posture, minimizing contractures and deformity, and facilitating mobility and dexterity, with the ultimate goal of maximizing the potential of the patient and promoting their independence and quality of life. The approach to spasticity in CP is complex and presents itself as a great challenge for the rehabilitation team. Radial extracorporeal shock wave therapy (rESWT) has been established in recent years as an effective, non-invasive alternative with hardly any side effects (small bruises or discomfort during the application) for the management of spasticity in patients with CP. rESWT is a relatively new therapy in the field of neurology, in 2010 was published the first clinical trial where shock waves were applied for the management of spasticity in patients with CP. Currently, few works have studied the efficacy of rESWT in patients with CP. In all of them, the results demonstrated the treatment's effectiveness in reducing spasticity locally in people with CP up to 3 months after the application. The group most studied muscle has been the Triceps Surae, and there is a great disparity regarding the doses of treatment applied in each study, especially regarding the number of sessions and the time interval between sessions. The most widely used protocol is 3 rESWT sessions with a time interval of 1 week between session; This protocol was established as the most effective in the treatment of trauma pathology. Despite all the variability in the administration of the dose, we have been able to observe that none of them has studied the effect of rESWT by lengthening the time interval between sessions beyond one week to check whether the therapeutic effects on spasticity can be prolonged over time by applying the same dose. Most of the studies conclude that future research should be aimed at studying the most optimal dose of treatment as well as evaluating the long-term results.

Who can participate

Age range

4 Years – 50 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: * Patients with CP. * With a CP classified as spastic. * Spasticity in the Triceps Surae muscle. * Who have a Gross Motor Classification (GMFCS) level between l and ll * Having signed the informed consent by the participant or your legal guardian Exclusion Criteria: * Have received treatment with shock waves in the Triceps Surae or any other muscle of the lower extremity in the 6 months before the study. * Have received treatment with botulinum toxin and/or treatment focal intramuscular injection with phenol or alcohol in the Triceps Surae or some other lower extremity muscle in the 6 months before the study. * Patients who have undergone surgery for deformities foot orthotics in the last year. * Fixed deformities in the ankle joint. * Clinical signs of myopathy and neuropathy. * Infection or tumor at the site of application of the therapy\*. * Severe blood dyscrasia\*. * Blood coagulation disorders\*. * Treatment with oral anticoagulants\* * Contraindications of radial extracorporeal shock wave therapy.

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

Change in passive range of movement and the stretching reflex in ankle dorsiflexion. Tardieu Scale

Timeframe: Base line,3,5,9,12 and 24 weeks

Change in goal attainment scale (GAS)

Timeframe: Setting of goal(s) at start (base line), assesment al 3,5,9,12 and 24 weeks

Trial details

NCT IDNCT05702606

SponsorFundacio Aspace Catalunya

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-03

View on ClinicalTrials.gov More Cerebral Palsy trials