Assessment of a Portable Digital Device for Quantified Analysis of Markerless Walking in Volunteers With Neuromuscular Diseases or Asymptomatic Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gait analysis via video capture.
- Who it may be relevant to
- Registry conditions: Spinal Muscular Atrophy (SMA), Charcot-Marie-Tooth, Muscular Dystrophy, Myotonic Dystrophy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Gait analysis via video capture
Using motion analysis software integrated into a smartphone
Primary outcome measures
- Vicon vs Myokinesis system correlation coefficient [Time frame: Day 1]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Centre d'Exploration et d'Évaluation Neuromusculaire — Paris
Identifiers
NCT: NCT07321977 · Myokinesis