Clinical trial NCT06234878: REEV SENSE for Gait Analysis in Post-stroke Gait Impairment (SENS-AG)
Official title: Validation of REEV SENSE Biomarkers Precision for Gait Analysis in Subjects With Post-stroke Gait Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait Disorders, Neurologic
Keywords: Stroke
Gait analysis
Accelerometer
Gait impairment
Lead sponsor: REEV LLC
Sponsor class: INDUSTRY
First posted: 2024-01-31
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Walking speed measure precision
timeFrame: Throughout study completion (an average of 2h)
Secondary outcomes:
measure: KPP (Knee Position Predictor) measure precision = precision of the predicted angle of knee sagittal flexion in the next 200ms
timeFrame: Throughout study completion (an average of 2h)
measure: Walking cadence measure precision = precision of the number of steps per minute
timeFrame: Throughout study completion (an average of 2h)
measure: Stride length measure precision
timeFrame: Throughout study completion (an average of 2h)
measure: Swing time measure precision
timeFrame: Throughout study completion (an average of 2h)
measure: Stance time measure precision
timeFrame: Throughout study completion (an average of 2h)
measure: Stance symmetry measure precision = precision of the % of unilateral stance time predominance (right or left) compared to total bilateral stance time (right and left)
timeFrame: Throughout study completion (an average of 2h)
measure: Knee flexion angle measure precision in sagittal plan
timeFrame: Throughout study completion (an average of 2h)
measure: Ankle flexion angle measure precision in sagittal plan
timeFrame: Throughout study completion (an average of 2h)
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: MIT Center for Clinical and Translational Research
state: Massachusetts
Study officials:
References: