NCT07293988 Spastic Myopathy in Adults With Cerebral Palsy
| NCT ID | NCT07293988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neuroloco |
| Condition | Cerebral Palsy (CP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-05-19 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2022-05-19 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07293988 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cerebral Palsy (CP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07293988 currently recruiting?
Yes, NCT07293988 is actively recruiting participants. Contact the research team at maud.pradines@u-pec.fr for enrollment information.
Where is the NCT07293988 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT07293988 clinical trial?
NCT07293988 is sponsored by Neuroloco. The trial plans to enroll 40 participants.
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