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

NCT ID: NCT07321977

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2027-01-06

Brief Summary

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.

Conditions

Spinal Muscular Atrophy (SMA); Charcot-Marie-Tooth; Muscular Dystrophy; Myotonic Dystrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Gait analysis via video capture

Intervention Type: OTHER

Using motion analysis software integrated into a smartphone

Interventions

Gait analysis via video capture

Using motion analysis software integrated into a smartphone

Intervention Type: OTHER

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut de Myologie, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre d'Exploration et d'Évaluation Neuromusculaire

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pauline SANTMARTY, MsC

Role: CONTACT

p.santmarty@institut-myologie.org

+33 01 42 16 58 79

Romain FEIGEAN, PhD

Role: CONTACT

r.feigean@institut-myologie.org

+33 142166649

Facility Contacts

Romain FEIGEAN, PhD

Role: primary

r.feigean@institut-myologie.org

+33 01 42 16 58 80

Other Identifiers

Myokinesis

Identifier Type: -

Identifier Source: org_study_id