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Recruiting Not applicable

Clinical Trial Evaluating the Impact of an Intensive Rehabilitation Program Combined With Tendon Vibratory Stimulation on Functional Balance in Individuals With Charcot-Marie-Tooth Disease Type 1A

NCT07726043 · tracked via the Priya Life Science France tracker
Sponsor
UGECAM PACA et Corse
Phase
Not applicable
Started
2025-04-28
Last updated
2026-08-03

Condition(s) studied

Charcot-Marie-Tooth Disease Type 1A

Investigational drug(s) / intervention(s)

Multidisciplinary rehabilitation program

Multidisciplinary rehabilitation program: 2-week intensive multidisciplinary rehabilitation program including physical therapy, occupational therapy, and adapted physical activity sessions, followed by balance assessments and evaluation of neuropathy status.

Study summary

Charcot-Marie-Tooth (CMT) disease is caused by a genetic abnormality involving the PMP22 gene, resulting in demyelination of the peripheral nerves. Demyelination leads to sensorimotor impairment and causes progressive muscle weakness and tendon contractures, initially affecting the lower limbs. Consequently, individuals with CMT experience balance impairments and gait disturbances, including ankle instability, foot drop, and postural instability, which lead to frequent falls and reduced quality of life. Currently, there is no disease-modifying treatment for CMT.

Several rehabilitation approaches have been proposed, including endurance training and muscle strengthening programs, to improve independence in activities of daily living. However, rehabilitation practices for individuals with CMT remain poorly standardized, and there is still a lack of clearly defined rehabilitation protocols, despite broad agreement among healthcare professionals regarding their potential benefits.

More recently, noninvasive focal tendon vibration has been investigated in several neurological disorders to improve sensory function, balance, and motor performance. Previous studies suggest that mechanical vibratory stimulation applied to the quadriceps tendon may induce sustained improvements in postural control and lower-limb muscle strength.

The present study aims to evaluate a rehabilitation program combined with tendon vibratory stimulation. The objective is to compare the effectiveness of a short-term (2-week), intensive multidisciplinary rehabilitation program focused on balance with different types of focal tendon vibration, in order to better address balance impairments and their associated complications in individuals with Charcot-Marie-Tooth disease.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Individuals with genetically confirmed Charcot-Marie-Tooth disease type 1A (CMT1A), characterized by PMP22 gene duplication on chromosome 17 (17p11.2). * Age between 18 and 65 years. * Overall Neuropathy Limitations Scale (ONLS) score between 2 and 3/7 for the lower limbs. * Affiliation with a social security/health insurance system. * Written informed consent voluntarily provided after receiving information regarding the study objectives, procedures, and potential risks. Exclusion Criteria: * Comorbidities causing peripheral neuropathy (e.g., diabetes, renal failure, medication-induced neuropathy). * Balance or gait disorders due to another cause. * Individuals without a permanent residence. * Individuals deprived of liberty by judicial or administrative decision or under legal guardianship. * Individuals unable to understand the study objectives and procedures or unable to provide informed consent. * Individuals unable to complete all study procedures. * Previous use of the Vibramoov device. * Pregnant women or women planning to become pregnant during the study period. * Concurrent participation in another research study.

Primary outcome measure(s)

  • Berg Balance Scale — Baseline, Week 3 , Week 7, Week 15
    The primary outcome measure of this study will be the assessment of balance using the Berg Balance Scale (BBS). The BBS is a 14-item scale in which each item is scored from 0 to 4 points and evaluates static and dynamic balance as well as fall risk. This scale has been validated in individuals with neurological disorders and has been used to assess balance impairments in individuals with Charcot-Marie-Tooth disease. The BBS has demonstrated good reliability and responsiveness to change. A change of 4 to 7 points, depending on the baseline score, has been identified as a clinically meaningful indicator of improvement in balance.

Trial sites (1)

FacilityCityRegionStatus
IUR Valmante Sud Marseille France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07726043 on ClinicalTrials.gov ↗ ← All trials in France