Inpatient Stroke Recovery Using Sensors
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Wearable sensors.
- Кому может быть актуально
- Состояния в реестре: Stroke. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Wearable Sensor Platform to Monitor Stroke Recovery During Inpatient Rehabilitation
Обзор
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
Подробное описание
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.
The investigators will obtain continuous biometric and movement-based sensor data for clinical symptoms (e.g., muscle activation, heart rate variability, talk time, and gait quality) during the performance of validated clinical tests and during general inpatient activities (e.g., therapy, eating, and sleeping).
The investigators will compare device data with clinically validated measures of movement and language function, such as the Modified Ashworth Scale or Western Aphasia Battery. The investigators will describe variation of device data in subgroups of subjects defined by clinician assessed clinically validated measures (10-Meter Walk Test, Mini-Mental Status Exam, etc.). The investigators will also assess the ability of the sensors to capture response to treatment, such as movement therapy, speech therapy, medication, and Botox by comparing sensor data before and after treatment. The investigators will provide evidence about the degree to which the measured variables are intercorrelated. Lastly, The investigators will evaluate and compare the state of recovery between patients at time of discharge using sensor-based outcomes. Due to heterogeneity of clinical symptoms after stroke, as differing etiologies and degrees of recovery result in different types and levels of gait impairments, preliminary analyses may be performed on specific sub-datasets to determine which predictors, data types, and other data compositions affect algorithm performance before their application and evaluation on the dataset collected at the end of this study. Sub-datasets may be sampled based on (but not limited to) the population characteristics, the sensors used, the data available at the time analysis.
Вмешательства
- Диагностический тест Wearable sensors
Utilizing wireless wearable sensors, to capture quantitative biometric and movement-based data.
Первичные конечные точки
- Discharge clinical scores estimation [Срок оценки: Discharge from inpatient stay. Average length of stay is 22 days.]
Вторичные конечные точки (9)
- Change in 6-Minute Walk Test (6MWT) [Срок оценки: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke]
- Change in 10-Meter Walk Test (10MWT) [Срок оценки: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke]
- Change in Berg Balance Scale (BBS) [Срок оценки: 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) [Срок оценки: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke]
- Change in Functional Gait Assessment (FGA) [Срок оценки: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke]
- Change in Gait Analysis [Срок оценки: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke]
- Three months clinical score estimation [Срок оценки: 3 months after the stroke event]
- Six months clinical score estimation [Срок оценки: 6 months after the stroke event]
- Twelve months clinical score estimation [Срок оценки: 12 months after the stroke event]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Shirley Ryan AbilityLab — Chicago
Идентификаторы
NCT: NCT04219670 · STU00205532