Spastic Myopathy in Adults With Cerebral Palsy

NCT07293988 | Recruiting DMC

• 2 other identifiers: 2020-A00041-382019-004945-33
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Maximal ambulation speed over 10 meters

  Maximal ambulation speed over 10 meters, barefoot

  Day 1, Month 6, Month 12

Secondary Outcomes (14)

• Plantar flexor clinical extensibility (XV1)

  Day 1, Month 6, Month 12

• Plantarflexor spasticity

  Day 1, Month 6, Month 12

• Active dorsiflexion (XA)

  Day 1, Month 6, Month 12

• LG Young modulus

  Day 1, Month 6, Month 12

• LG fascicle length

  Day 1, Month 6, Month 12

Study Arms (2)

Guided Self-rehab group

EXPERIMENTAL

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

Behavioral: Guided Self-rehabilitation Contract

Control group

OTHER

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

Behavioral: Conventional therapy group

Interventions

Guided Self-rehabilitation Contract 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

Guided Self-rehab group

Conventional therapy group 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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuroloco: lead

Study Sites (1)

Maud Pradines

Créteil, Île-de-France Region, 94010, France

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Paresis

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

MAUD PRADINES, PT, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 19, 2025
• Study Start: May 19, 2022
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2029
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)