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Cerebral Palsy (CP)MYOSPAS-IMCNCT07293988

Spastic Myopathy in Adults With Cerebral Palsy

A study testing Guided Self-rehabilitation Contract and Conventional therapy group in people with Cerebral Palsy (CP), run by Neuroloco at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebral Palsy (CP)
What is being tested?
Guided Self-rehabilitation Contract and Conventional therapy group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteFrance
Study dates
19 May 2022to 30 Nov 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

MAUD PRADINES, PT, PhD contact

+33 676 845 339

maud.pradines@u-pec.fr

France1 site, 1 recruiting
  • Maud Pradines

    Créteil, Île-de-France Region, 94010

    MAUD PRADINES, PT, PhD, +33 676 845 339, maud.pradines@u-pec.fr

    AUTHIER FRANCOIS JEROME, PU-PH, +33 149 812 735, francois-jerome.authier@aphp.fr

    Recruiting

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Guided Self-rehabilitation Contract, Conventional therapy group
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
Medical subject headings
Cerebral Palsy, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guided Self-rehabilitation ContractBehavioural

    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 groupBehavioural

    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 groups in NCT07293988
Study groupRoleWhat they receive
Guided Self-rehab groupExperimentalIn 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
Receives: Behavioral: Guided Self-rehabilitation Contract
Control groupOtherIn the control group, subjects follow their rehabilitation sessions (conventional therapy) as before their enrollment
Receives: Behavioral: Conventional therapy group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal ambulation speed over 10 meters

    Maximal ambulation speed over 10 meters, barefoot

    Measured: Day 1, Month 6, Month 12

Secondary outcomes (14)
  1. Plantar flexor clinical extensibility (XV1)

    Passive ankle dorsiflexion were assessed using standardized Tardieu Scale procedures. XV1 was measured during a very slow, strong passive stretch of the gastrocnemius with the patient supine, knee extended. The stretch was performed over 3-5 seconds to minimize stretch-reflex activation, and the maximal angle at which soft-tissue resistance could no longer be overcome was recorded as the passive maximal dorsiflexion range (XV1).

    Measured: Day 1, Month 6, Month 12

  2. Plantarflexor spasticity

    XV3 was obtained under identical positioning as XV1 but during a rapid stretch (V3). To ensure the muscle was fully relaxed prior to the fast movement, the examiner performed several quick oscillatory pre-movements in the opposite direction. The angle of catch or clonus during the fast stretch defined XV3.

    Measured: Day 1, Month 6, Month 12

  3. Active dorsiflexion (XA)

    XA represented maximal active dorsiflexion, measured with the patient supine and knee extended, reflecting both passive and active constraints imposed by the gastrocnemius.

    Measured: Day 1, Month 6, Month 12

  4. LG Young modulus

    Participants were assessed using a share wave elastography system while seated in an isokinetic ergometer (trunk at 60°, knee extended, ankle fixed). The lateral gastrocnemius (GL) shear modulus (µGL) were measured through nine sites (superior, middle, inferior, medial, medium, lateral). Measurements were performed under two ankle positions: 40° plantarflexion (non-stretched LG) and 80% of individual XV1-GAS (stretched LG). For each site and condition, 10-second cine loops were recorded (a validated acquisition method), yielding 10 videos per participant. Each video was then divided into 10 DICOM frames to obtain reliable µGL estimates. Image processing and µGL extraction were performed using MATLAB®.

    Measured: Day 1, Month 6, Month 12

  5. LG fascicle length

    Participants were assessed using a high frequency ultrasound system while seated in an isokinetic ergometer (trunk at 60°, knee extended, ankle fixed). Structural ultrasound images at the middle/medium location were analyzed to derive fascicle length

    Measured: Day 1, Month 6, Month 12

  6. LG Tickness

    Participants were assessed using a hifh frequency ultrasound system while seated in an isokinetic ergometer (trunk at 60°, knee extended, ankle fixed). Structural ultrasound images at the middle/medium location were analyzed to determine muscle thickness

    Measured: Day 1, Month 6, Month 12

  7. LG Muscle volume

    A high-field 3T MRI examination of both the paretic and contralateral lateral gastrocnemius muscles will be performed using a flexible surface coil positioned around the patient's calves. Muscle volume will be quantified from a series of continuous axial T1-weighted slices acquired along the full length of the calf.

    Measured: Day 1, Month 12

  8. Intramuscular fat percentage

    A high-field 3T MRI examination of both the paretic and contralateral lateral gastrocnemius muscles will be performed using a flexible surface coil positioned around the patient's calves. Intramuscular fat percentage will be estimated using a Dixon sequence, allowing reliable separation of water and fat signals.

    Measured: Day 1, Month 12

  9. LG hyperelastic behavior under compression

    A micro-invasive muscle biopsy using a Weil-Blakesley forceps will be performed twice, one year apart, on both the paretic and contralateral lateral gastrocnemius of each participant. This technique will be carried out by a trained investigator under local anesthesia. The biopsy will target the LG muscle belly, yielding approximately 30 mg of tissue for in vitro biomechanical analysis. Using an MTS Insight machine, fresh muscle fragments will undergo sequential uniaxial tensile and compressive relaxation tests. These procedures will enable detailed quantification of hyperelastic behavior under compression.

    Measured: Day 1, Month 12

  10. LG fiber-type composition

    From biopsies, ~30 mg of tissue will be cryosectioned to visualize 400-500 fibers. Immunohistochemistry will determine fiber-type composition (fast/slow myosin)

    Measured: Day 1, Month 12

  11. LG endo-/perimysial fibrosis

    From biopsies, ~30 mg of LG tissue will be cryosectioned to visualize 400-500 fibers. Standard stainings (H\&E, Gomori Trichrome, COX, Sirius Red) will assess endo-/perimysial fibrosis.

    Measured: Day 1, Month 12

  12. LG genetic expression

    From biopsies, ~30 mg of LG tissue will be used to examine the expression of 57 genes related to skeletal muscle structure, myogenic differentiation, metabolic regulation, and atrophy pathways. RNA will be extracted with the Nano PreAMP kit (Qiagen), and gene expression profiled using the RT² Profiler™ PCR Array - Human Skeletal Muscle Development \& Disease. The targeted gene groups include markers of the dystrophin-glycoprotein and titin complexes, fast and slow fiber signatures, energy metabolism, myogenesis (MYOD1, MYOG, PAX3/7), atrophy/autophagy (FBXO32, TRIM63, TNF)

    Measured: Day 1, Month 12

  13. LG spastic cocontraction

    Participants will be equipped with bilateral surface EMG electrodes on the tibialis anterior and lateral gastrocnemius (ME6000, 16-channel WiFi system; 1000 Hz). LG spastic cocontraction will be quantified during maximal dorsiflexion effort. When technically feasible, Mmax will be used as an alternative denominator of MVC in these ratios through tibial nerve stimulation

    Measured: Day 1, Month 12

  14. Plantar/dorsiflexion strength

    Participants will be positioned in the ConTrex device, at two ankle positions (40° plantarflexion = relaxed GL; and 80% XV1-GAS = stretched GL). The maximal strength in dorsiflexion and plantarflexion will be quantified by the isokinetic ergometer.

    Measured: Day 1, Month 6, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2025
  2. Study start19 May 2022
  3. Primary completion30 Nov 2028 (estimated)
  4. Study completion30 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07293988
Sponsor's protocol ID
2020-A00041-38
Other IDs
2019-004945-33, 2019
Acronym
MYOSPAS-IMC
Status last verified
Dec 2025
First submitted
26 Nov 2025
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Guided Self-rehabilitation Contract and Conventional therapy group in people with Cerebral Palsy (CP), run by Neuroloco at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MAUD PRADINES, PT, PhD (+33 676 845 339, maud.pradines@u-pec.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal ambulation speed over 10 meters (time frame: Day 1, Month 6, Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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