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Charcot-Marie-Tooth Disease Type 1AEQUIVIB-CMTNCT07726043

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

A study testing Multidisciplinary rehabilitation program in people with Charcot-Marie-Tooth Disease Type 1A, run by UGECAM PACA et Corse at 1 site in France.

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Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Charcot-Marie-Tooth Disease Type 1A
What is being tested?
Multidisciplinary rehabilitation program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteFrance
Study dates
28 Apr 2025to 31 Dec 2027
Phase
Interventional

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • Previous use of the Vibramoov device.
  • Pregnant women or women planning to become pregnant during the study period.
  • Concurrent participation in another research study.

Trial locations and contacts

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

Clotilde Pheulpin, MD contact

France1 site, 1 recruiting
  • IUR Valmante Sud

    Marseille, 13009

    Laurent Bensoussan, MD, +33 4 91 74 42 00, laurent.bensoussan@ugecam.assurance-maladie.fr

    Recruiting

Other trials in France

About this study

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.

Read more

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.

Read the detailed description

Charcot-Marie-Tooth (CMT) disease is the most common inherited peripheral neuropathy, with a prevalence ranging from 3.1 to 82.3 per 100,000 individuals. It is caused by genetic abnormalities affecting peripheral nerves. The most common form, accounting for approximately 60% of CMT cases, is Charcot-Marie-Tooth disease type 1A (CMT1A). CMT1A is characterized by a demyelinating neuropathy, autosomal dominant inheritance, and a mutation involving the PMP22 gene.

The first clinical signs of the disease typically appear before the age of 20 years and consist of a length-dependent sensorimotor impairment with distal predominance and diffuse areflexia. The disease primarily affects the lower limbs; upper limb involvement is variable and may develop after several years of disease progression. These impairments result in progressive distal muscle weakness associated with muscle atrophy, tendon contractures leading to pes cavus and claw toe deformities, and mild-to-moderate distal sensory impairment. These manifestations lead to major functional complaints among individuals with CMT, including balance disorders, gait disturbances related to ankle instability, foot clearance difficulties during the swing phase, and postural instability, resulting in frequent falls and impaired quality of life.

Currently, there is no disease-modifying treatment for CMT.

Assistive devices and lower-limb orthotic management may be prescribed. Surgical treatment may be considered in cases of severe and disabling musculoskeletal deformities.

Several rehabilitation approaches have been proposed, including endurance training and strengthening programs to improve independence in activities of daily living, as well as aerobic training programs aimed at improving functional capacity, aerobic capacity, muscle strength, and fatigue in individuals with CMT. The French National Diagnostic and Care Protocol (PNDS) for hereditary motor and sensory neuropathies associated with CMT highlights the lack of standardized rehabilitation practices and clearly defined protocols, despite a consensus among healthcare professionals regarding their potential benefits. Indeed, the literature includes only one randomized controlled trial, published in 2006, with a small sample size (n = 16), demonstrating improvements in balance, assessed using the Berg Balance Scale (BBS), following a two-week dynamic training program combining passive stretching, muscle strengthening, and standing balance exercises.

In addition, non-invasive focal tendon vibration has been proposed in several neurological disorders to improve sensory function, balance, and motor performance, particularly in individuals with diabetic peripheral neuropathy. Some studies suggest that mechanical vibratory stimulation applied to the quadriceps tendon may induce sustained improvements in postural control and lower-limb strength in women over 60 years of age.

In individuals with CMT, a pilot study involving 14 participants with CMT1A demonstrated improved balance performance on the Berg Balance Scale following three consecutive days of musculoskeletal vibration therapy applied to the quadriceps and triceps surae muscles.

In this context, we selected the Vibramoov device, a neurorehabilitation device that has already demonstrated clinical benefits in comparable studies involving other neurological disorders. Vibramoov delivers vibrations applied at the musculotendinous junction, thereby mechanically stimulating muscle spindles and reproducing the sensory signals associated with natural movement. This approach, already validated in other clinical settings, represents a promising strategy to improve balance and gait in individuals with CMT by integrating it into an intensive multidisciplinary rehabilitation program.

Therefore, it appears relevant to investigate a specific intensive multidisciplinary rehabilitation program combined with mechanical vibratory stimulation to improve functional balance and gait abilities in individuals with CMT.

Being tested
Multidisciplinary rehabilitation program
Keywords
Charcot-Marie-Tooth Disease, Vibration, Balance
Medical subject headings
Charcot-Marie-Tooth Disease

What participants receive

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

  • Multidisciplinary rehabilitation programOther

    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 groups in NCT07726043
Study groupRoleWhat they receive
With mechanical vibratory stimulationExperimentalNot described
Receives: Other: Multidisciplinary rehabilitation program
Without mechanical vibratory stimulationSham comparatorNot described
Receives: Other: Multidisciplinary rehabilitation program

What is being measured

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

  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.

    Measured: Baseline, Week 3 , Week 7, Week 15

Secondary outcomes (12)
  1. CMT Neuropathy Score

    This validated score provides a reliable measure of overall neuropathy severity.

    Measured: Baseline, Week 3 , Week 7, Week 15

  2. Posturography

    Assessment of balance and proprioception by recording center of pressure sway on a force platform.

    Measured: Baseline, Week 3, Week 7, Week 15

  3. Timed Up and Go (TUG) test

    This test is used to identify individuals at risk of falls and to assess functional mobility. Participants are timed while standing up from a chair without armrests, walking 3 meters, turning around, walking back to the chair, and sitting down.

    Measured: Baseline, Week 3, Week 7, Week 15

  4. Knee joint position sense assessment using electronic goniometers

    Participants will be seated with their knees flexed at 90°. The examiner will passively move the knee to a target angle. After returning to the starting position, participants, with their eyes closed, will be asked to actively reproduce the target knee position.

    Measured: Baseline, Week 3, Week 7, Week 15

  5. Gait assessment

    6-Minute Walk Test (6MWT): Assessment of walking endurance. Walking distance (meters) and number of rest stops will be recorded.

    Measured: Baseline, Week 3, Week 7, Week 15

  6. Walking speed

    10-Meter Walk Test (10MWT): Assessment of self-selected walking speed by measuring the time (seconds) required to walk 10 meters.

    Measured: Baseline, Week3, Week 7, Week 15

  7. Borg Rate of Perceived Extorsion (RPE) scale

    Measure of perceived exertion (Borg Rate of Perceived Extorsion (RPE) scale from 1 - "at rest" to 10 - "maximal") during during walk speed assessment.

    Measured: Baseline, Week 3, Week 7, Week 15

  8. Muscle strength assessment

    Muscle strength will be assessed using the Medical Research Council (MRC) scale (0 - "no movement" to 5 - "normal force") for the tibialis anterior, extensor hallucis longus, extensor digitorum longus, triceps surae, peroneal, quadriceps, and hamstring muscles.

    Measured: Baseline, Week 3, Week 7, Week 15

  9. Patient-Reported Outcome: R-ODS questionnaire

    The Rasch-built Overall Disability Scale (R-ODS) with 24 items is a questionnaire that reflects how neuropathy affects the patient's daily and social activities. Scale 0 - "impossible" to 48 - "without difficulties".

    Measured: Baseline, Week 3, Week 7, Week 15

  10. Patient-Reported Outcome: FSS Scale

    The Fatigue Severity Scale (FSS) is a short questionnaire with 9 items that requires the patient to rate their level of fatigue for each item from 0 - "strongly diasagree" to 7 - "strongly agree".

    Measured: Baseline, Week 3, Week 7, Week 15

  11. Patient-Reported Outcome: QoL NMD v1.0

    The Quality of Life in Neuromuscular Disease (QoL NMD v1.0) is a questionnaire with 26 items that assesses the quality of life in patients with neuromuscular disease. The final score is between 0 -"Poor" and 75 - "Excellent".

    Measured: Baseline, Week 3, Week 7, Week 15

  12. Patient-reported Outcome: NRS Scale

    The Numeric Rating Scale (NRS) assesses pain intensity using a 0 - 10 ranking scale with 0 representing "no pain" and 10 "unbearable pain"

    Measured: Baseline, Week 3, Week 7, Week 15

Timeline

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

  1. First posted24 Jul 2026
  2. Study start28 Apr 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07726043
Sponsor's protocol ID
2024-A02577-40
Other IDs
2024-A02577-40
Acronym
EQUIVIB-CMT
Status last verified
Jul 2026
First submitted
21 Jul 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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