Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2017-10-31
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Patient Group
Individuals diagnosed with stroke admitted to the Shirley Ryan AbilityLab (inpatient), or individuals in the community who had a stroke (chronic)
Wearable sensors
Utilizing wireless wearable sensors, to capture quantitative biometric and movement-based data.
Healthy Control Group
Individuals without any known significant health problems
Wearable sensors
Utilizing wireless wearable sensors, to capture quantitative biometric and movement-based data.
Interventions
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Wearable sensors
Utilizing wireless wearable sensors, to capture quantitative biometric and movement-based data.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
Yes
Sponsors
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Shirley Ryan AbilityLab
OTHER
Responsible Party
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Arun Jayaraman, PT, PhD
Director, Max Nader Center for Rehabilitation Technologies & Outcomes Research
Principal Investigators
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Arun Jayaraman, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Sara Prokup, DPT
Role: primary
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form: ICF for Chronic stroke and healthy control participants
Document Type: Informed Consent Form: ICF for Inpatient participants
Other Identifiers
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STU00205532
Identifier Type: -
Identifier Source: org_study_id