Inpatient Stroke Recovery Using Sensors

NCT04219670 | Recruiting

• 1 other identifier: STU00205532
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Keywords

Stroke; Device Studies; Noninvasive Procedures; Device Feasibility; Inpatient Rehabilitation; Sensors; Machine Learning

Outcome Measures

Primary Outcomes (1)

• Discharge clinical scores estimation

  Error between clinical scores estimated from machine learning algorithms trained on sensor data from the Admission time-point, and true scores assessed at the discharge from the hospital.

  Discharge from inpatient stay. Average length of stay is 22 days.

Secondary Outcomes (9)

• Change in 6-Minute Walk Test (6MWT)

  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)

  From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke

• Change in Berg Balance Scale (BBS)

  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)

  From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke

• Change in Functional Gait Assessment (FGA)

  From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke

Study Arms (2)

Patient Group

Individuals diagnosed with stroke admitted to the Shirley Ryan AbilityLab (inpatient), or individuals in the community who had a stroke (chronic)

Diagnostic Test: Wearable sensors

Healthy Control Group

Individuals without any known significant health problems

Diagnostic Test: Wearable sensors

Interventions

Wearable sensors DIAGNOSTIC_TEST

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

Healthy Control Group; Patient Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arun Jayaraman, PT, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arun Jayaraman, PT, PhD

CONTACT

3122386875; a-jayaraman@northwestern.edu

Sara Prokup, PT, DPT

CONTACT

3122381355; sprokup@ricres.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Max Nader Center for Rehabilitation Technologies & Outcomes Research

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: January 7, 2020
• Study Start: October 31, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

US (1)