Wearable Sensor Platform to Monitor Stroke Recovery During Inpatient Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Discharge clinical scores estimation
研究概览
简要总结
This observational trial seeks to assess the feasibility of using non-invasive, portable, real-time body-worn sensors to continuously monitor, quantify, and interpret recovery during inpatient treatment of stroke
详细描述
OBJECTIVES:
Aim 1: Assess the feasibility of continuous long-term monitoring of inpatients with stroke using wearable sensors.
The investigators will obtain quantitative health data from research-grade, wireless, wearable sensors on individuals with subacute and chronic stroke in the clinical setting, as well as healthy controls.
The investigators will specifically check for variability in device data, as well as consistency and periodicity of sensor readings across the clinical study period. The investigators will analyze test-retest reliability and inter-rater reliability of using the wearable sensor technology for clinical and monitoring applications. Furthermore, The investigators will determine whether the sensors can distinguish biometric and activity characteristics between healthy controls and individuals with stroke.
Aim 2: Quantify upper and lower extremity movement impairments, mobility-related activities, speech and swallowing activities, and clinical parameters during stroke recovery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient group
- •Individuals diagnosed with stroke admitted to the Shirley Ryan AbilityLab (inpatient), or individuals in the community who had a stroke (chronic)
- •Age 18 or older
- •Able and willing to give written consent and comply with study procedures
- •Healthy control group
- •Individuals without any known significant health problem (healthy controls)
- •Age 18 or older
- •Able and willing to give written consent and comply with study procedures
排除标准
- •Patient group
- •Neurological degenerative pathologies as co-morbidities (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
- •Pregnant or nursing
- •Skin allergies or irritation; open wounds
- •Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
- •Healthy control group
- •No known history of cerebrovascular accidents or neurological degenerative pathologies (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
- •Pregnant or nursing
- •Skin allergies or irritation; open wounds
- •Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
结局指标
主要结局
Discharge clinical scores estimation
时间窗: Discharge from inpatient stay. Average length of stay is 22 days.
Error between clinical scores estimated from machine learning algorithms trained on sensor data from the Admission time-point, and true scores assessed at the discharge from the hospital.
次要结局
- Change in Berg Balance Scale (BBS)(From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke)
- Change in Gait Analysis(From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke)
- Change in 6-Minute Walk Test (6MWT)(From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke)
- Change in Timed Up and Go (TUG)(From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke)
- Change in Functional Gait Assessment (FGA)(From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke)
- Three months clinical score estimation(3 months after the stroke event)
- Twelve months clinical score estimation(12 months after the stroke event)
- Change in 10-Meter Walk Test (10MWT)(From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke)
- Six months clinical score estimation(6 months after the stroke event)
研究者
Arun Jayaraman, PT, PhD
Director, Max Nader Center for Rehabilitation Technologies & Outcomes Research
Shirley Ryan AbilityLab