Guided self-stretching for spastic calf muscles in adults with cerebral palsy
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
This trial will test whether a guided daily self-stretching program can lengthen calf muscles and improve walking in adults with cerebral palsy who have stiff, shortened calf muscles.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Neuroloco Academic / other |
| Locations | 1 site (Créteil, Île-de-France Region) |
| Trial ID | NCT07293988 on ClinicalTrials.gov |
What this trial studies
This randomized, single-blind study compares a Guided Self-Rehabilitation Contract (high-load daily stretching) with conventional therapy in adults with hemiparesis or diparesis due to cerebral palsy. Investigators will use muscle imaging, biomechanical testing, clinical walking assessments, and micro-invasive gastrocnemius biopsy to document structural and functional muscle changes. The protocol includes genetic, histological, radiological, mechanical, physiological, and clinical outcome measures to determine whether muscle alterations are reversible with intensive self-stretching. Participants will be adults with reduced calf extensibility and moderate walking speed who can consent and follow the program.
Who should consider this trial
Good fit: Adults with cerebral palsy (hemiparesis or diparesis) who have limited gastrocnemius extensibility (XV1 < 100°), a barefoot walking speed of 0.3–1.2 m/s, and the ability to consent and perform daily self-stretching are ideal candidates.
Not a fit: People with recent botulinum toxin injections to the gastrocnemius, implanted electronic or certain metallic devices, bleeding disorders, severe cognitive impairment, or inability to commit to daily stretching are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could restore calf muscle extensibility and architecture and improve ankle range and walking speed without surgery.
How similar studies have performed: Preliminary studies and a randomized trial in adults with acquired hemiparesis have shown increased fascicle length, muscle thickness, and improved gait speed after prolonged high-load self-stretching, supporting the plausibility of this approach though long-term adult CP data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Créteil, Île-de-France Region
- Maud Pradines — Créteil, Île-de-France Region, France (Recruiting)
Study contacts
- Study coordinator: MAUD PRADINES, PT, PhD
- Email: maud.pradines@u-pec.fr
- Phone: +33 676 845 339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.