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Starting soon Observational

Physical Activity Level at Home in CMT1A Patients: Wearable Sensor Assessment

NCT07591779 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-06-01
Last updated
2026-05-22

Condition(s) studied

Charcot-Marie-Tooth Disease, Type IAPeripheral Neuropathy HereditaryMotor ActivityWalking, DifficultyNeuromuscular Diseases

Study summary

Charcot-Marie-Tooth disease type 1A (CMT1A) is the most common hereditary peripheral neuropathy, affecting approximately 26,000 patients in France. It presents as chronic and progressive sensorimotor deficits predominantly affecting the distal lower limbs, with onset typically in childhood. There is currently no specific pharmacological treatment; management remains symptomatic.

This research will:

In the long run, validated wearable sensors could improve patient follow-up, personalize rehabilitation, and support the design of clinical trials for CMT1A - including trials of the novel "Nano-Cur" treatment currently under development.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years 2. Genetically confirmed diagnosis of CMT1A (PMP22 duplication on chromosomal analysis) 3. Followed at the National Reference Centre for Rare Peripheral Neuropathies (Service de Neurologie, CHU de Limoges) and/or having undergone gait analysis at the Quantified Movement Analysis Laboratory (Laboratoire d'AQM), Service de Médecine Physique et de Réadaptation, CHU de Limoges 4. Ability to walk independently (with or without walking aids) 5. Informed consent obtained 6. Affiliated to French social security system Exclusion Criteria: 1. Other associated neurological condition that could independently affect walking or motor activity 2. Inability to wear the sensor device (skin allergy, sensory intolerance) 3. Inability to comply with study procedures (cognitive impairment, no fixed domicile) 4. Participation in another interventional study during the same period 5. Pregnant or breastfeeding women 6. Patients under legal protection (guardianship or curatorship)

Primary outcome measure(s)

  • Pearson/Spearman r: daily step count (ActiGraph) vs. CMT-FOM total score — Day 1 (CMT-FOM)
    Correlation coefficient (r : -1 to +1) between mean daily step count (steps/day) over 7 days and CMT-FOM total score obtained at Day 1 hospital visit.
  • Pearson/Spearman r: daily step count (ActiGraph) vs. CMT-FOM total score — Day 7 (home monitoring)
    Correlation coefficient (r : -1 to +1) between mean daily step count (steps/day) over 7 days and CMT-FOM total score obtained at Day 1 hospital visit.
  • Pearson/Spearman r: daily activity counts (ActiGraph) vs. CMT-FOM total score — Day 1
    Correlation coefficient (r : -1 to +1) between mean daily activity counts (raw accelerometry counts/day) over 7 days and CMT-FOM total score.
  • Pearson/Spearman r: daily activity counts (ActiGraph) vs. CMT-FOM total score — Day 7 (home monitoring)
    Correlation coefficient (r : -1 to +1) between mean daily activity counts (raw accelerometry counts/day) over 7 days and CMT-FOM total score.
  • Pearson/Spearman r: daily sedentary time (ActiGraph) vs. CMT-FOM total score — Day 1
    Correlation coefficient (r : -1 to +1) between mean daily sedentary time (minutes/day) over 7 days and CMT-FOM total score.
  • Pearson/Spearman r: daily sedentary time (ActiGraph) vs. CMT-FOM total score — Day 7 (home monitoring)
    Correlation coefficient (r : -1 to +1) between mean daily sedentary time (minutes/day) over 7 days and CMT-FOM total score.
  • Pearson/Spearman r: composite sensor score vs. CMT-FOM sub-scores — Day 1
    Correlation coefficient (r : -1 to +1) between ActiGraph-derived metrics and CMT-FOM sub-domain scores (upper limb, lower limb, balance, endurance). Reported separately per sub-score.
  • Pearson/Spearman r: composite sensor score vs. CMT-FOM sub-scores — Day 7 (home monitoring)
    Correlation coefficients (r : -1 to +1) between ActiGraph-derived metrics and CMT-FOM sub-domain scores (upper limb, lower limb, balance, endurance). Reported separately per sub-score.

Trial sites (1)

FacilityCityRegionStatus
Chu de Limoges Limoges France
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 NCT07591779 on ClinicalTrials.gov ↗ ← All trials in France