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NCT Number: NCT07321977

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Gait analysis via video capture

Other

Using motion analysis software integrated into a smartphone

Primary outcomes

  1. Vicon vs Myokinesis system correlation coefficient

    Time frame: Day 1

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Pauline SANTMARTY, MsC

CONTACT

[email protected]

+33 01 42 16 58 79

Romain FEIGEAN, PhD

CONTACT

[email protected]

+33 142166649

Sponsors and collaborators

Lead sponsor

Institut de Myologie, France

Other

Registry information

Acronym: Myokinesis

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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