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Recruiting Not applicable

Spastic Myopathy in Adults With Cerebral Palsy

NCT07293988 · tracked via the Priya Life Science France tracker
Sponsor
Neuroloco
Phase
Not applicable
Started
2022-05-19
Last updated
2025-12-19

Condition(s) studied

Cerebral Palsy (CP)

Investigational drug(s) / intervention(s)

Guided Self-rehabilitation ContractConventional therapy group

Guided Self-rehabilitation Contract: Participants randomized to the intervention arm will receive a one-year individualized program based on the Guided Self-Rehabilitation Contract (GSC) method. A physiotherapist specifically trained in GSC will supervise all 20 patients. The therapist will conduct monthly 1.5-hour home visits, supplemented as needed by intermediate webcam or telephone consultations. The GSC method aims to increase the patient's knowledge, responsibility, and active involvement in their rehabilitation. Its core psychological mechanism is the use of a daily quantified logbook (paper, electronic, or the i-GSC™ smartphone/tablet application). Patients must record daily stretching time per muscle and the number of active movements performed in each series. The therapist explains that maintaining this logbook is a central component of the therapeutic contract. At each visit, the logbook is reviewed to enhance data accuracy, monitor motivation, reinforce adherence, and provide positive feedback-mechanisms show

Conventional therapy group: In this group, subjects follow their rehabilitation sessions as before their enrollment. Conventional physiotherapy will typically consist of one to three sessions per week, delivered either in a private outpatient practice or at the patient's home, depending on the medical prescription. Session duration and therapeutic content may vary, reflecting routine real-life practice. Quantitative and qualitative data regarding conventional physiotherapy will be collected for all subjects throughout the study

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Maximal ambulation speed over 10 meters — Day 1, Month 6, Month 12
    Maximal ambulation speed over 10 meters, barefoot

Trial sites (1)

FacilityCityRegionStatus
Maud Pradines Créteil Île-de-France Region Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07293988 on ClinicalTrials.gov ↗ ← All trials in France