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 | Recruiting

• 1 other identifier: 2024-A02577-40
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Charcot-Marie-Tooth Disease Type 1A

Keywords

Charcot-Marie-Tooth Disease, Vibramoov, Balance

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  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.

  At enrollment, at the end of rehabilitation, 5 weeks after the end of rehabilitation, 13 weeks after the end of rehabilitation

Secondary Outcomes (1)

• CMT Neuropathy Score

  At enrollment, at the end of rehabilitation, 5 weeks after the end of rehabilitation, 13 weeks after the end of rehabilitation

Study Arms (2)

With mechanical vibratory stimulation

EXPERIMENTAL

Other: Multidisciplinary rehabilitation program

Without mechanical vibratory stimulation

SHAM COMPARATOR

Other: Multidisciplinary rehabilitation program

Interventions

Multidisciplinary rehabilitation program OTHER

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.

With mechanical vibratory stimulation; Without mechanical vibratory stimulation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UGECAM PACA et Corse: lead

Study Sites (1)

IUR Valmante Sud

Marseille, 13009, France

RECRUITING

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Central Study Contacts

Laurent Bensoussan, MD

CONTACT

+33 4 91 74 42 00; laurent.bensoussan@ugecam.assurance-maladie.fr

Clotilde Pheulpin, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: April 28, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

FR (1)