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RECRUITING
NCT07293988
NA

Spastic Myopathy in Adults With Cerebral Palsy

Sponsor: Neuroloco

View on ClinicalTrials.gov

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.

Official title: Clinical, Biomechanical, Histo-immunological and Radiological Characterization of the Effects of Two Gastrocnemius Stretching Programs in Adult Patients With Spastic Paresis Following Cerebral Palsy: MYOSPAS-CP, a Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2022-05-19

Completion Date

2029-11-30

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

BEHAVIORAL

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

BEHAVIORAL

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

Locations (1)

Maud Pradines

Créteil, Île-de-France Region, France