IMUSEP : Use of Inertial Navigation Systems to Detect and Characterize Early Locomotor Disorders in Patients With Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) for validity of the Trigno® Avanti Sensor
研究概览
简要总结
The goal of this case control study is to evaluate the use of inertial navigation systems to detect and characterize early locomotor disorders in patients with multiple sclerosis (MS). The study aims to:
• Validate the contribution and inefficiency indexes obtained by the Trigno® Avanti Sensor inertial units, in comparison with indexes calculated with 3D motion analysis during walking and tandem in early-stage MS patients.
Researchers will compare MS patients, to healthy controls.
详细描述
Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system, and the leading cause of non-traumatic neurological disability in young adults. It affects around 100,000 people in France, and 5,000 are newly diagnosed each year. It generally begins between the ages of 20 and 40, and mainly affects women (sex ratio 3 women/1 man).
The clinical presentation of MS is highly polymorphic. Patients may present with motor deficits, sensory disorders, spasticity, gait disorders, balance disorders, visual disturbances, etc. The symptoms that have the greatest impact on patients' quality of life in the first 5 years following diagnosis are gait and balance disorders. However, these early disorders are barely visible on clinical examination, and are not highlighted by the balance and gait tests frequently used in routine practice. These sub-clinical locomotor disorders are also not taken into account by the Expanded Disability Status Scale (EDSS). However, the discomfort reported by patients is objectified using the Multiple Sclerosis Walking Scale-12 (MSWS-12) questionnaire.
The management of balance and gait disorders is essential to limit deconditioning during exercise and reduce their impact on patients' quality of life. Detecting these disorders is therefore a key factor in improving our understanding of them, and enabling us to provide appropriate rehabilitation.
In the early stages, gait and balance disorders can be detected by means of three-dimensional movement analysis.
Certain parameters, such as contribution and inefficiency indexes, have proved useful in detecting and quantifying gait and balance disorders in early-stage MS patients. These indexes are based on the calculation of linear moments. The contribution index reflects the contribution of each body segment to body forward motion, while the inefficiency index reflects the motor performance of a segment in carrying out a locomotor task. These indices could provide physical markers for quantifying balance and gait disorders and their progression, and thus help in disease monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •for patient:
- •Age 18 to 65 (inclusive)
- •Expanded Disability Status Scale (EDSS) ≤ 4
- •Proficient in French
- •Agreeing to participate in the study and having signed the informed consent form
- •Affiliated with a social security scheme
- •Inclusion Criteria for Volunteers:
- •Age 18 to 65 (inclusive)
- •Proficient in French
- •Agreeing to participate in the study and having signed the informed consent form
- •Affiliated with a social security plan
排除标准
- •for patient:
- •MS crisis within the last 6 weeks
- •Botulinum toxin injection in the last 3 months
- •Neurological pathology other than MS
- •Disabling musculoskeletal pathology
- •Unstable cardiac and respiratory pathology
- •Pregnant women
- •Patients with comprehension or cognitive disorders
- •Recent change in background treatment (< 3 months)
- •Patients under guardianship or curatorship
- •Presence of implanted electronic devices of any kind, including pacemakers or similar assistive devices, electronic infusion pumps and implanted pacemakers
- •Allergy to silver
- •Exclusion Criteria for Volunteers:
- •Neurological pathology
- •Rheumatological pathology
- •Antecedent of sprains (< 3 months), fractures (< 1 year) in the lower limbs
- •Pregnant women
- •Person under guardianship or trusteeship
- •Presence of implanted electronic devices of any kind, including pacemakers or similar assistive devices electronic infusion pumps and implanted pacemakers
- •Allergy to silver
研究组 & 干预措施
Volunteers
Volunteers without pathology
干预措施: Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device test (Diagnostic Test)
Patient with multiple sclerosis
Patient with multiple sclerosis
干预措施: Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device test (Diagnostic Test)
结局指标
主要结局
Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) for validity of the Trigno® Avanti Sensor
时间窗: 1 month
Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) will be calculated to validate the contribution and inefficiency indexes obtained by the Trigno® Avanti Sensor inertial units, in comparison with indexes calculated with 3D motion analysis during walking and tandem in early-stage MS patients, and in healthy controls. The coefficient are interpreted as follows: (\>0.8) very high correlation, (0.61-0.79) good correlation, moderate correlation, (0.41-0.60) low correlation if less bad correlation. These quantified indexes could be used as physical markers to quantify both the balance deterioration and the efficiency of rehabilitation program during the follow up of MS from the early stage of their disease..
次要结局
- Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) for repeatability(1 month)
- Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95% )for the whole-body angular momentum(Baseline, 1 month)
- Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) between the Expanded Disability Status Scale (EDSS) and the contribution and inefficiency indexes(1 month)
- Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) between the MSWS-12 (multiple sclerosis walking scale-two weeks) and the contribution and inefficiency indexes(1 month)
- Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) between the MSWS-12 and whole-body angular momentum method (Trigno® Avanti Sensor inertial units / 3D 3D).(1 month)
- Differences in contribution and inefficiency indexes between groups(1 month)