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临床试验/NCT07293988
NCT07293988招募中不适用

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

Neuroloco2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月19日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Maximal ambulation speed over 10 meters

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Maximal ambulation speed over 10 meters

时间窗: Day 1, Month 6, Month 12

Maximal ambulation speed over 10 meters, barefoot

次要结局

  • 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)
  • LG Tickness(Day 1, Month 6, Month 12)
  • LG Muscle volume(Day 1, Month 12)
  • Intramuscular fat percentage(Day 1, Month 12)
  • LG hyperelastic behavior under compression(Day 1, Month 12)
  • LG fiber-type composition(Day 1, Month 12)
  • LG endo-/perimysial fibrosis(Day 1, Month 12)
  • LG genetic expression(Day 1, Month 12)
  • LG spastic cocontraction(Day 1, Month 12)
  • Plantar/dorsiflexion strength(Day 1, Month 6, Month 12)

研究者

发起方
Neuroloco
申办方类型
Other
责任方
Sponsor

研究点 (2)

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