RecruitingNot Applicable

Spastic Myopathy in Adults With Cerebral Palsy

France40 participantsStarted 2022-05-19

Plain-language summary

Cerebral palsy (CP) is indeed the result of a central neurological lesion, but it also involves a lesser-known muscular condition that we refer to as spastic myopathy. This condition is likely the consequence of relative immobilization and underuse of the muscles in the affected limbs and, through a vicious cycle, it in turn plays a major role in movement difficulties. Among the muscles involved are the plantar flexors, whose extensibility decreases from the earliest years of the child's life. The BIOTN research team (UR7377; Université Paris-Est Créteil; Dr M. Pradines, Prof. J.-M. Gracies, CHU Henri Mondor, Créteil), supported by the Fondation pour la Paralysie Cérébrale, is conducting a randomized controlled study aimed, on the one hand, at characterizing in these individuals the genetic, histological, radiological, mechanical, physiological, and clinical changes in the calf muscle, and on the other hand, at exploring the reversibility of these alterations by comparing the effects of two types of rehabilitation after one year. This study will provide essential insights for the development of specific and adapted rehabilitation strategies designed to improve the living conditions of individuals with cerebral palsy.

Who can participate

Age range

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: * Hemiparesis or diparesis resulting from a cerebral lesion occurring during the perinatal period (cerebral palsy). * Gastrocnemius extensibility XV1 \< 100° (XV1, Tardieu Scale). * Maximum barefoot walking speed (AT10) between 0.3 and 1.2 m/s. * Written informed consent to participate in the study. Exclusion Criteria: * Botulinum toxin injections in the medial gastrocnemius within less than 3 months prior to study inclusion. * Cognitive impairment preventing participation in the GSC program or in the study. * Patients under legal guardianship or conservatorship. * Known hemostasis disorders. * Hypersensitivity to allergens. * Presence of a metallic intraocular foreign body (accidental fragments or others), a pacemaker, a neurostimulator (pain treatment), a cochlear implant, or, more generally, any implanted electronic medical device that cannot be removed; presence of a metallic cardiac valve in the study participant.

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

Maximal ambulation speed over 10 meters

Timeframe: Day 1, Month 6, Month 12

Trial details

NCT IDNCT07293988

SponsorNeuroloco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-11-30

Contact for this trial

MAUD PRADINES, PT, PhD

+33 676 845 339 maud.pradines@u-pec.fr

View on ClinicalTrials.gov More Cerebral Palsy (CP) trials