Assessment of a Portable Digital Device for Quantified Analysis of Markerless Walking in Volunteers With Neuromuscular Diseases or Asymptomatic Volunteers (Myokinesis)

In recent years, knowledge of neuromuscular diseases has advanced considerably, and new therapeutic avenues are beginning to emerge. The proliferation of clinical trials has created a need to identify biomarkers that are both sensitive to changes and specific to the disease. Current gait tests only consider the time factor and not the evolution of the patient's biomechanics, which may prove insufficient for patients whose symptoms generally progress slowly. Quantifying gait parameters in neuromuscular patients therefore appears necessary. This is why we propose to study markerless gait analysis in this population, which would allow for simple and effective monitoring of kinematic parameters without resorting to complex equipment incompatible with routine clinical practice.

Study Overview

• Status: Recruiting
• Conditions: Muscular Dystrophy; Myotonic Dystrophy; Spinal Muscular Atrophy (SMA); Charcot-Marie-Tooth
• Intervention / Treatment: Other: Gait analysis via video capture

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pauline SANTMARTY, MsC; Phone Number: +33 01 42 16 58 79; Email: p.santmarty@institut-myologie.org
• Study Contact Backup: Name: Romain FEIGEAN, PhD; Phone Number: +33 142166649; Email: r.feigean@institut-myologie.org

Study Locations

• France
  • Paris, France
    • Recruiting
    • Centre d'Exploration et d'Évaluation Neuromusculaire
    • Contact: Romain FEIGEAN, PhD; Phone Number: +33 01 42 16 58 80; Email: r.feigean@institut-myologie.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

• All volunteers

  • Age between 18 and 65
  • Ambulatory
  • Informed consent to participate in the study
  • Member of or beneficiary of a social security system

• Volunteers with a neuromuscular disease

  • Confirmed diagnosis of a neuromuscular disease of genetic origin (medical document to be provided upon enrollment in the study with proof of diagnosis) belonging to the list above.
  • Ability to walk for 2 minutes without assistance.
  • Ability to stand up from a chair with armrests at least 3 times in 30 seconds.
  • Ability to climb an inclined plane independently or with assistance to access the movement analysis room.

Exclusion Criteria

• All volunteers

  • Individuals under guardianship, curatorship, or legal protection
  • Pregnant or breastfeeding women
  • Non-ambulatory individuals
  • Individuals with epilepsy
  • Skin conditions preventing the placement of VICON motion sensors

• Asymptomatic volunteers

  • Unstable respiratory or cardiac problems
  • Neurological, musculoskeletal, or psychiatric problems

• Volunteers with a neuromuscular disease

  • Recent trauma or serious falls (≤ 6 months)
  • Individuals who have fallen more than twice in the past year and at least once in the past three months
  • Use of assistive devices such as rigid knee braces or walkers
  • Unstable cardiomyopathy
  • Individuals awaiting diagnosis

Exclusion criteria

• Inability to comply with the protocol requirements
• Medical or social conditions that could interfere with the study, as determined by the coordinating investigator or co-investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Volunteers with Neuromuscular disease or asymptomatic; All participants have the same intervention. The intervention is to walk with shoes in a gait analysis room with VICON markers on the body. At the same time, the participant will be film by two smartphones to compare the kinematics and the spatio-temporal parameters between a marker-based and a markerless gait analysis.	Other: Gait analysis via video capture; Using motion analysis software integrated into a smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vicon vs Myokinesis system correlation coefficient	Correlation coefficient between measurements from the two systems in both groups, for spatiotemporal parameters and joint range of motion in the sagittal plane at the hip, knee, and ankle	Day 1

Collaborators and Investigators

• Sponsor: Institut de Myologie, France

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2026
• Primary Completion (Estimated): July 6, 2026
• Study Completion (Estimated): January 6, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: neuromuscular; gait analysis; disease; markerless
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Neuromuscular Diseases; Genetic Diseases, Inborn; Peripheral Nervous System Diseases; Neurodegenerative Diseases; Congenital Abnormalities; Heredodegenerative Disorders, Nervous System; Muscular Disorders, Atrophic; Spinal Cord Diseases; Nervous System Malformations; Motor Neuron Disease; Polyneuropathies; Myotonic Disorders; Hereditary Sensory and Motor Neuropathy; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Disease; Muscular Dystrophies; Myotonic Dystrophy; Muscular Atrophy, Spinal; Charcot-Marie-Tooth Disease
• Other Study ID Numbers: Myokinesis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No