Assessment of a Portable Digital Device for Quantified Analysis of Markerless Walking in Volunteers With Neuromuscular Diseases or Asymptomatic Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Vicon vs Myokinesis system correlation coefficient
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Gait analysis via video capture (Other)
结局指标
主要结局
Vicon vs Myokinesis system correlation coefficient
时间窗: 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
次要结局
未报告次要终点