Clinical trial NCT04219670: Inpatient Stroke Recovery Using Sensors
Official title: Wearable Sensor Platform to Monitor Stroke Recovery During Inpatient Rehabilitation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: Stroke
Device Studies
Noninvasive Procedures
Device Feasibility
Inpatient Rehabilitation
Sensors
Machine Learning
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient cohort will consist of stroke survivors both admitted as inpatients to the Shirley Ryan AbilityLab and individuals in the community who had a stroke. The healthy control cohort will be recruited from the community sample.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Discharge clinical scores estimation
timeFrame: Discharge from inpatient stay. Average length of stay is 22 days.
Secondary outcomes:
measure: Change in 6-Minute Walk Test (6MWT)
timeFrame: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke
measure: Change in 10-Meter Walk Test (10MWT)
timeFrame: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke
measure: Change in Berg Balance Scale (BBS)
timeFrame: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke
measure: Change in Timed Up and Go (TUG)
timeFrame: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke
measure: Change in Functional Gait Assessment (FGA)
timeFrame: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke
measure: Change in Gait Analysis
timeFrame: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke
measure: Three months clinical score estimation
timeFrame: 3 months after the stroke event
measure: Six months clinical score estimation
timeFrame: 6 months after the stroke event
measure: Twelve months clinical score estimation
timeFrame: 12 months after the stroke event
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Study Principal Investigator
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: