CompletedNot Applicable

Radial Extracorporeal Shock Wave Therapy for Spastic Plantar Flexor Muscles in Young Children With Cerebral Palsy

66 participantsStarted 2014-04

Plain-language summary

The purpose of this study is to determine whether radial extracorporeal shock wave therapy in combination with traditional physical therapy is safe and effective for the management of spastic plantar flexor muscles in patients with cerebral palsy younger than averaged three years of age.

Who can participate

Age range

12 Months – 60 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: * diagnosis of cerebral palsy * spasticity of plantar flexor muscles greater than Grade 1 and up to Grade 4 according to the modified Ashworth scale * availability to attend the hospital during the treatment and follow-up assessments Exclusion Criteria: * fixed contractures or deformities at the left ankle * myopathies * clinical signs of myopathy and neuropathy * treatment with shock waves in the past * treatment with Botulinum neurotoxin A and/or focal intramuscular treatment with phenol and alcohol in the past * previous surgery of the left foot, ankle and leg * treatment with drugs for spasticity control * infection or tumor at the site of therapy application\* * serious blood dyscrasia\* * blood-clotting 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

Modified Ashworth Scale (MAS) grade of the plantar flexor muscles

Timeframe: Three months after baseline

Trial details

NCT IDNCT02719483

SponsorThe First Hospital of Jilin University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-07

View on ClinicalTrials.gov More Muscle Spasticity trials

Who can participate

Age range

12 Months – 60 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.