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Recruiting NCT04219670

Inpatient Stroke Recovery Using Sensors

Observational Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Wearable sensors.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Wearable Sensor Platform to Monitor Stroke Recovery During Inpatient Rehabilitation

Overview

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.

Interventions

  • Diagnostic test Wearable sensors
    Utilizing wireless wearable sensors, to capture quantitative biometric and movement-based data.

Primary outcome measures

  • Discharge clinical scores estimation [Time frame: Discharge from inpatient stay. Average length of stay is 22 days.]
Secondary outcome measures (9)
  • Change in 6-Minute Walk Test (6MWT) [Time frame: 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) [Time frame: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke]
  • Change in Berg Balance Scale (BBS) [Time frame: 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) [Time frame: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke]
  • Change in Functional Gait Assessment (FGA) [Time frame: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke]
  • Change in Gait Analysis [Time frame: From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke]
  • Three months clinical score estimation [Time frame: 3 months after the stroke event]
  • Six months clinical score estimation [Time frame: 6 months after the stroke event]
  • Twelve months clinical score estimation [Time frame: 12 months after the stroke event]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Shirley Ryan AbilityLab — Chicago

Identifiers

NCT: NCT04219670 · STU00205532

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗