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

Institut de Myologie, France

Status: Enrolling

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

Treatments: Other: Gait analysis via video capture

Study type: Interventional

Funder types: Other

Identifiers

NCT07321977

Myokinesis

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Volunteers with Neuromuscular disease or asymptomatic

Other group

Description:

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.

Treatment:

Other: Gait analysis via video capture