An interventional study of Multidisciplinary rehabilitation program in Charcot-Marie-Tooth Disease Type 1A, sponsored by UGECAM PACA et Corse. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by UGECAM PACA et Corse · Not applicable, Interventional, and Supportive care
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Among 23 studies in Charcot-Marie-Tooth Disease with a site in France — 6 open to participants now, 10 under way, 2 of them phase 3. Charcot-Marie-Tooth Disease · France.
Among the 23 studies in Charcot-Marie-Tooth Disease with a site in France, this one is the 13th largest by planned enrollment of the 17 interventional ones that give a count, is one of 3 that started in 2025, is one of 10 with no phase, and was the 23rd registered.
113 studies on the registry are indexed under Charcot-Marie-Tooth Disease; 37 are open to participants now.
Browse Charcot-Marie-Tooth Disease studies →6 of the 23 studies in Charcot-Marie-Tooth Disease with a site in France are open now. Recruiting first, the newest first:
Hospices Civils de Lyon · Sites in France
Ages 4+
Institut de Myologie, France · Sites in France
Ages 18–65 · Healthy volunteers
Assistance Publique Hopitaux De Marseille · Sites in France
Ages 18+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
University Hospital, Limoges · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 31 Charcot-Marie-Tooth Disease studies recruiting now, 14 (45%) set no upper age limit and 13 (42%) stop at 75 or younger; 14 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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23 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 41 across 62 interventional studies indexed under Charcot-Marie-Tooth Disease.
Median enrollment 67 across the 17 interventional studies, 53 across the 6 observational. Of the 12 that completed or were terminated, 3 (25%) have results posted.
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3 of 23 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with UGECAM PACA et Corse as lead sponsor.
UGECAM PACA et Corse has 1 study filed under Charcot-Marie-Tooth Disease — fewer than ten, so there is no comparison to draw.
6 of the studies in Charcot-Marie-Tooth Disease with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07321977Institut de Myologie, FranceAssessment of a Portable Digital Device for Quantified Analysis of Markerless Walking in Volunteers With Neuromuscular Diseases or Asymptomatic Volunteers | 2026-12-31 |
| NCT07591779University Hospital, LimogesPhysical Activity Level at Home in CMT1A Patients: Wearable Sensor Assessment | 2027-04-15 |
| NCT02596191Assistance Publique Hopitaux De MarseilleTools for Therapeutic Evaluation in Charcot-Marie-Tooth Disease Type 1A: Outcome Measures and Biomarkers | 2027-05-05 |
| NCT06845644Assistance Publique Hopitaux De MarseilleLongitudinal Quantitative Neuromuscular MRI in Neuropathic Patients | 2027-05-23 |
| NCT07038239Hospices Civils de LyonGenotype/Phenotype Correlation of MORC2 Mutations | 2027-06 |
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Among the 23 studies in Charcot-Marie-Tooth Disease with a site in France, from their registry updates:
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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.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Multidisciplinary rehabilitation program
Other: 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.
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.
Time frame: Baseline, Week 3 , Week 7, Week 15
CMT Neuropathy Score
This validated score provides a reliable measure of overall neuropathy severity.
Time frame: Baseline, Week 3 , Week 7, Week 15
Posturography
Assessment of balance and proprioception by recording center of pressure sway on a force platform.
Time frame: Baseline, Week 3, Week 7, Week 15
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.
Time frame: Baseline, Week 3, Week 7, Week 15
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.
Time frame: Baseline, Week 3, Week 7, Week 15
Gait assessment
6-Minute Walk Test (6MWT): Assessment of walking endurance. Walking distance (meters) and number of rest stops will be recorded.
Time frame: Baseline, Week 3, Week 7, Week 15
Walking speed
10-Meter Walk Test (10MWT): Assessment of self-selected walking speed by measuring the time (seconds) required to walk 10 meters.
Time frame: Baseline, Week3, Week 7, Week 15
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.
Time frame: Baseline, Week 3, Week 7, Week 15
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.
Time frame: Baseline, Week 3, Week 7, Week 15
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".
Time frame: Baseline, Week 3, Week 7, Week 15
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".
Time frame: Baseline, Week 3, Week 7, Week 15
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".
Time frame: Baseline, Week 3, Week 7, Week 15
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"
Time frame: Baseline, Week 3, Week 7, Week 15
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Dec 2027, 32 months after the start.
Of 38 non-industry interventional studies with no phase under Charcot-Marie-Tooth Disease, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 67. This study's planned 32 months is above that.
Counting every sponsor, half of 38 studies reached it within 29 months; a quarter within 7 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
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