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MC10 Inpatient Stroke Recovery

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ClinicalTrials.gov Identifier: NCT04219670
Recruitment Status : Active, not recruiting
First Posted : January 7, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

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
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.

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Study Type : Observational
Estimated 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 : October 31, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Group/Cohort 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.




Primary Outcome Measures :
  1. Change in 10-Meter Walk Test [ Time Frame: 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.

  2. Change in 6 Minute Walk Test [ Time Frame: 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 :
  1. Change in Timed Up and Go [ Time Frame: 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.

  2. Change in Berg Balance Test [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The inpatient cohort will consist of stroke survivors admitted as inpatients to the Shirley Ryan AbilityLab. The healthy control cohort will be recruited from the community sample.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219670


Locations
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United States, Illinois
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Shirley Ryan AbilityLab
Investigators
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Principal Investigator: Arun Jayaraman, PT, PhD Study Principal Investigator
  Study Documents (Full-Text)

Documents provided by Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab:
Study Protocol  [PDF] February 28, 2018
Informed Consent Form  [PDF] July 28, 2018

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Responsible Party: Arun Jayaraman, PT, PhD, Director, Max Nader Center for Rehabilitation Technologies & Outcomes Research, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT04219670    
Other Study ID Numbers: STU00205532
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab:
Stroke
Device Studies
Noninvasive Procedures
Device Feasibility
Inpatient Rehabilitation
Sensors
MC10
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases