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

Stroke Clinical Trial

— SENS-AG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234878
• Other study ID #: REEV-RS-01
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: REEV LLC
• Contact: Amaury Ciurana, MS
• Phone: 8572109698
• Email: amaury.ciurana[@]reev.care
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Stroke

Intervention

Device:
• REEV SENSE
Gait analysis with an Inertial Measurement Unit (IMU) sensor
• Motion capture system
Gait analysis with reflective markers and pressure sensors

Locations

Country	Name	City	State
United States	MIT Center for Clinical and Translational Research	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
REEV LLC

Country where clinical trial is conducted

United States, 

Outcome

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