Skip to main content
OpenTrials
Completed

NCT Number: NCT06234878

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MIT Center for Clinical and Translational Research

Cambridge, Massachusetts, 02139, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REEV SENSE

Device

Gait analysis with an Inertial Measurement Unit (IMU) sensor

Motion capture system

Device

Gait analysis with reflective markers and pressure sensors

Primary outcomes

  1. Walking speed measure precision

    Time frame: Throughout study completion (an average of 2h)

    Comparison of walking speed measured with REEV SENSE with reference method

Secondary outcomes

  1. 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.

  2. 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

  3. Stride length measure precision

    Time frame: Throughout study completion (an average of 2h)

    Comparison of stride length measured with REEV SENSE with reference method

  4. Swing time measure precision

    Time frame: Throughout study completion (an average of 2h)

    Comparison of swing time measured with REEV SENSE with reference method

  5. Stance time measure precision

    Time frame: Throughout study completion (an average of 2h)

    Comparison of stance time measured with REEV SENSE with reference method

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

REEV LLC

Industry

Registry information

Official study title

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

Acronym: SENS-AG

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2024
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.