Spastic Myopathy in Adults With Cerebral Palsy

NCT ID: NCT07293988

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-19
• Study Completion Date: 2029-11-30

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.

Detailed Description

Cerebral palsy (CP), resulting from a perinatal central neurological lesion, leads not only to lifelong motor impairment but also to a specific muscular disorder: spastic myopathy. This condition is characterized by early and progressive structural changes including decreased passive extensibility (XV1), reduced muscle fiber diameter, decreased number of sarcomeres in series, and hypertrophy of the endomysium and perimysium. In children, impaired gastrocnemius growth-quantified by reduced medial gastrocnemius muscle volume-appears before age 3 and precedes both hyperactivity and fixed stiffness. However, the long-term consequences of decades of underuse on the mechanical, histological, and morphometric properties of the gastrocnemius in adults with IP remain insufficiently explored.

Stretching, although widely prescribed, lacks standardized parameters, and its long-term effectiveness in adults with IP has never been formally evaluated. Evidence suggests that muscular plasticity requires high-load stretching and ≥10 minutes per muscle per day. Preliminary studies using Guided Self-Rehabilitation Contracts (GSCs) demonstrated significant gains in extensibility and function, while a randomized controlled trial in adults with acquired hemiparesis showed increased fascicle length, increased muscle thickness, and improved gait speed after one year of high-load self-stretching, supporting the reversibility of molecular pathways driving contracture.

This single-blind randomized controlled trial includes 40 adults with IP, randomized to: (1) conventional physiotherapy alone, or (2) conventional physiotherapy + a one-year daily GSC-based high-load gastrocnemius self-stretching program (10 minutes/day + phasic maximal dorsiflexion efforts). Multi-scale assessments span six analytical domains: clinical measures (XV1, XV3, XA; gait speed; SF-36), in vivo tissue biomechanics (resistance torque, passive energy, fascicle length, muscle thickness), functional and neurophysiological biomechanics (agonist-antagonist recruitment during gait), MRI morphometry (volume, intramuscular fat, edema), in vitro biomechanics (compressibility, strain, rupture stress), and genetic/histological markers (satellite cells, expression profile of 57 myogenic genes). Micro-invasive biopsies of both limbs will be performed at J1 and M12.

The primary outcome is maximal barefoot 10-meter gait speed. Secondary outcomes will characterize, chronologically and mechanistically, the trajectory of spastic myopathy and the potential of long-term high-load stretching to partially reverse its pathogenic processes.

Conditions

Cerebral Palsy (CP)

Keywords

cerebral palsy; fascicle length; spastic myopathy; micro-invasive biopsy; daily self-stretch posture; muscle volume; muscle thickness; fiber diameter; fiber type; myosin isoform chain; MRI; elastography; stiffness; shear modulus; spastic cocontraction; paresis; gait speed; micro-tester; gastrocnemius

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Guided Self-rehab group

In the interventional group, subjects will follow a Guided Self-rehabilitation program based on daily high-load gastrocnemius self-stretching postures (10 minutes/day) and phasic maximal dorsiflexion efforts

Group Type: EXPERIMENTAL

Guided Self-rehabilitation Contract

Intervention Type: BEHAVIORAL

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

Control group

In the control group, subjects follow their rehabilitation sessions (conventional therapy) as before their enrollment

Group Type: OTHER

Conventional therapy group

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuroloco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maud Pradines

Créteil, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

MAUD PRADINES, PT, PhD

Role: CONTACT

Phone: +33 676 845 339

Email: maud.pradines@u-pec.fr

Facility Contacts

MAUD PRADINES, PT, PhD

Role: primary

AUTHIER FRANCOIS JEROME, PU-PH

Role: backup

Other Identifiers

2019-004945-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2020-A00041-38

Identifier Type: -

Identifier Source: org_study_id