REEV SENSE for Gait Analysis in Post-stroke Gait Impairment (SENS-AG) (SENS-AG)

April 10, 2025 updated by: REEV LLC

Validation of REEV SENSE Biomarkers Precision for Gait Analysis in Subjects With Post-stroke Gait Impairment

The purpose of this study is to evaluate the clinical performance of the investigational REEV SENSE gait tracker to measure gait features in subjects with post-stroke gait impairment.

REEV SENSE is intended to be used by trained healthcare professionals as a simple procedure adapted to clinical routine.

The reference method for performance comparison will be motion capture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

REEV SENSE is a medical device, with pending FDA and CE certifications in class 1. It is a connected gait tracker set primarily on the leg or foot, and eventually on lower limb locations. It contains an accelerometer, a certified standard battery and motion analysis algorithms that will rapidly compute easy-to-use walking analyses accessible to healthcare professionals on a mobile app.

Standard gait biomarkers such as velocity, stride length, or stance and swing times will be computed. However, REEV has also developed a new biomarker, the knee position predictor (KPP), which will provide a more accurate quantification of each individual gait profile.

The present REEV SENSE study is the first to test subjects with a pathological context, i.e. with post-stroke ambulation deficit. Performance of REEV SENSE has already been established in healthy volunteers in comparison to the reference motion capture system, indicating good technical and metrological performance.

The study will take place at the MIT Center for Clinical and Translational Research (CCTR), a reference center with a fully equipped gait lab.

Each participating volunteer will be equipped with REEV SENSE and the reference motion capture system. The participant will be asked to walk at a comfortable self selected pace for about 15 minutes back and forth along a 10m walkway. He or she may rest at any time during the walking session. REEV SENSE and motion capture data will be recorded automatically and simultaneously during the same walking session.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • MIT Center for Clinical and Translational Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Post-stroke gait disorder.
  • Must be able to walk independently with or without the support of a cane or rollator.
  • History of stroke more than six months ago.
  • Be 18 years of age or older.

Exclusion Criteria:

  • Subject unable to give consent.
  • Subject unable to understand the tests.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gait analysis
Gait analysis with the investigational and the reference devices
Device: REEV SENSE
Gait analysis with an Inertial Measurement Unit (IMU) sensor
Device: Motion capture system
Gait analysis with reflective markers and pressure sensors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking speed measure precision
Time Frame: Throughout study completion (an average of 2h)
Comparison of walking speed measured with REEV SENSE with reference method
Throughout study completion (an average of 2h)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KPP (Knee Position Predictor) measure precision = precision of the predicted angle of knee sagittal flexion in the next 200ms
Time Frame: Throughout study completion (an average of 2h)
Comparison of KPP measured with REEV SENSE with reference method.
Throughout study completion (an average of 2h)
Walking cadence measure precision = precision of the number of steps per minute
Time Frame: Throughout study completion (an average of 2h)
Comparison of walking cadence measured with REEV SENSE with reference method
Throughout study completion (an average of 2h)
Stride length measure precision
Time Frame: Throughout study completion (an average of 2h)
Comparison of stride length measured with REEV SENSE with reference method
Throughout study completion (an average of 2h)
Swing time measure precision
Time Frame: Throughout study completion (an average of 2h)
Comparison of swing time measured with REEV SENSE with reference method
Throughout study completion (an average of 2h)
Stance time measure precision
Time Frame: Throughout study completion (an average of 2h)
Comparison of stance time measured with REEV SENSE with reference method
Throughout study completion (an average of 2h)
Stance symmetry measure precision = precision of the % of unilateral stance time predominance (right or left) compared to total bilateral stance time (right and left)
Time Frame: Throughout study completion (an average of 2h)
Comparison of stance symmetry measured with REEV SENSE with reference method
Throughout study completion (an average of 2h)
Knee flexion angle measure precision in sagittal plan
Time Frame: Throughout study completion (an average of 2h)
Comparison of knee flexion measured with REEV SENSE with reference method
Throughout study completion (an average of 2h)
Ankle flexion angle measure precision in sagittal plan
Time Frame: Throughout study completion (an average of 2h)
Comparison of ankle flexion angle measured with REEV SENSE with reference method
Throughout study completion (an average of 2h)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

REEV LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REEV-RS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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