Wearable Biosensor to Track and Quantify Limb Dysfunction in Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Discrimination of walking disorder status
研究概览
简要总结
Multiple sclerosis (MS) is a leading cause of neurological injury in young adults. Capturing the extent of multiple domains of MS-related disability is critical for effective clinical care and the development of new paradigms for patient-focused therapeutic approaches. To date outcomes research in MS has centered on clinical exams, which may be insensitive over the short term (the 1-2 years of early stage clinical trials) and only capture a single snapshot of the patient's performance.
With the mass production of sensors in the gaming and computer control industry, there is an opportunity to transform the traditional neurological exam with biosensors already in use outside the realm of health applications. The investigators herein propose to use a commercialized wearable electroMYOgraphy sensor (MYO,Thalamic Labs Inc, Kitchener, ON, Canada) for detection of upper and lower limb dysfunction in MS patients. The investigators will determine if the device can differentiate the diseased states, refine signal processing algorithms to create reliable outcomes using this device in MS patients, and determine if these outcomes are strongly associated with patients and physicians reported ambulatory and dexterity metrics. The investigators hypothesize that this digital technology may be introduced in the standard neurological exam technique in a non-disruptive manner and more accurately and potentially remotely detect both physician-reported and patient-reported disability.
In the scope of this study, the investigators will also develop signal processing methodology to comprehensively track ambulation features.
详细描述
Multiple sclerosis (MS) is a leading cause of neurological injury in young adults. Capturing the extent of multiple domains of MS-related disability is critical for effective clinical care and the development of new paradigms for patient-focused therapeutic approaches. To date outcomes research in MS has centered on clinical exams, which may be insensitive over the short term (the 1-2 years of early stage clinical trials) and only capture a single snapshot of the patient's performance.
With the mass production of sensors in the gaming and computer control industry, there is an opportunity to transform the traditional neurological exam with biosensors already in use outside the realm of health applications. The investigators herein propose to use a commercialized wearable electroMYOgraphy sensor (MYO,Thalamic Labs Inc, Kitchener, ON, Canada) for detection of upper and lower limb dysfunction in MS patients. The investigators will determine if the device can differentiate the diseased states, refine signal processing algorithms to create reliable outcomes using this device in MS patients, and determine if these outcomes are strongly associated with patients and physicians reported ambulatory and dexterity metrics. The investigators hypothesize that this digital technology may be introduced in the standard neurological exam technique in a non-disruptive manner and more accurately and potentially remotely detect both physician-reported and patient-reported disability.
In the scope of this study, the investigators will also develop signal processing methodology to comprehensively track ambulation features.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 to 64 years inclusive (Patients over 64 years will not be enrolled to avoid possible effect of aging on the voluntary movement assessed);
- •Confirmed diagnosis of MS according to the revised McDonald criteria (including primary progressive, secondary progressive and relapsing-remitting MS) with brain lesions consistent with MS if data available;
- •No history of relapse in the previous 5 weeks.
- •Must be able or think they are able to attempt both finger and foot tapping tests, F2NT, 9HPT and be ambulatory with or without assistance.
排除标准
- •Pregnant women
- •Adults under guardianship
- •Adults over 64 years
研究组 & 干预措施
patients with MYO armband
干预措施: Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada) (Device)
结局指标
主要结局
Discrimination of walking disorder status
时间窗: Day 0
Normal or Abnormal walking status of MS patients will be determined at baseline based on clinical judgement and compared to EMG data from calf muscle of the more affected limb combined with Inertial Motion Unit (IMU).
次要结局
- Foot tapping test(day 0)
- Finger tapping test(day 0)
- Heel-knee test(day 0)
- Romberg test(day 0)
- Finger to nose test(day 0)
- Timed 25 foot walk test result(day 0)
- Expanded disability status scores (EDSS)(Day 0 and at one year)
- Disability as measured with EDSS score(Day 0 and at one year)
- Disability as measured with Functional systems score (FS)(Day 0 and at one year)
- Dysfunction assessed by Romberg test(Day 0 and at one year)
- Nine holes peg test(day 0)
- Patient-reported disability using self-report questionnaire(Day 0 and at one year)
- Dysfunction assessed by finger to nose test(Day 0 and at one year)
- Twelve items Multiple Sclerosis Walking Scale Assessment (MSWS-12) scale(Day 0 and at one year)
- 12-item version of World Health Organization Disability Assessment Schedule (WHODAS 2.0)(Day 0 and at one year)
- Dysfunction assessed by walking disorder status(Day 0 and at one year)
- Dysfunction assessed by foot tapping test(Day 0 and at one year)
- Dysfunction assessed by nine holes peg test(Day 0 and at one year)
- Dysfunction assessed by finger tapping test(Day 0 and at one year)
- Dysfunction assessed by heel-knee test(Day 0 and at one year)
- Dysfunction assessed by timed 25 foot walk test result(Day 0 and at one year)