MC10 Inpatient Stroke Recovery

Sponsor

Shirley Ryan AbilityLab (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04219670

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Diagnostic Test: MC10 BioStampRC

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 (including MC10 BioStampRC) on individuals with subacute and chronic stroke in the inpatient 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Wearable Sensor Platform to Monitor Stroke Recovery During Inpatient Rehabilitation

Actual Study Start Date :

Oct 31, 2017

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Inpatient Group Inpatient stroke survivors who are currently undergoing rehabilitation at the Shirley Ryan AbilityLab setting	Diagnostic Test: MC10 BioStampRC Utilizing wireless wearable sensors, MC10 BiostampRC, to capture quantitative biometric and movement-based data.
Healthy Control Group Individuals without any known significant health problems	Diagnostic Test: MC10 BioStampRC Utilizing wireless wearable sensors, MC10 BiostampRC, to capture quantitative biometric and movement-based data.

Arm

Intervention/Treatment

Inpatient Group

Inpatient stroke survivors who are currently undergoing rehabilitation at the Shirley Ryan AbilityLab setting

Diagnostic Test: MC10 BioStampRC

Utilizing wireless wearable sensors, MC10 BiostampRC, to capture quantitative biometric and movement-based data.

Healthy Control Group

Individuals without any known significant health problems

Diagnostic Test: MC10 BioStampRC

Utilizing wireless wearable sensors, MC10 BiostampRC, to capture quantitative biometric and movement-based data.

Outcome Measures

Primary Outcome Measures

Change in 10-Meter Walk Test [10-Meter Walk Test speed will be assessed at study admission (Day 1) and approximately at discharge from hospital (on average, Day 17), and the change in speeds will be recorded.]
The 10-Meter Walk Test assesses subject walking speed in meters per second for 10 meters. Subjects will repeat the test three times and the average speed will be recorded.
Change in 6 Minute Walk Test [6 Minute Walk Test distance will be assessed at study admission (Day 1) and approximately at discharge from hospital (on average, Day 17), and the change in distance will be recorded.]
The 6 minute walk test is performed as an objective evaluation of functional exercise capacity. The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded.

Secondary Outcome Measures

Change in Timed Up and Go [Time Up and Go will be assessed at study admission (Day 1) and approximately at discharge from hospital (on average, Day 17), and the change in time will be recorded.]
The Timed Up and Go is a timed test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leaned up against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.
Change in Berg Balance Test [The Berg Balance Test score will be assessed at study admission (Day 1) and approximately at discharge from hospital (on average, Day 17), and the change in score will be recorded.]
The Berg Balance Test is a standardized 14-item objective measure of postural stability and static balance; it is an established fall predictor in adults. Balance is measured during various tasks on a 5 point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function, with a total possible score of 56. A score of 20 or less indicates a high fall risk.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Inpatient group
Individuals diagnosed with stroke admitted to the Shirley Ryan AbilityLab (inpatient), or individuals without any known significant health problem (healthy controls)
Age 18-100 years or older
Able and willing to give written consent and comply with study procedures
Healthy control group
Age 18 -100 years or older
Able and willing to give written consent and comply with study procedures

Exclusion Criteria:

Inpatient group
Serious cardiac conditions or 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)