MIT Center for Clinical and Translational Research
Cambridge, Massachusetts, 02139, United States
NCT Number: NCT06234878
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cambridge, Massachusetts, 02139, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Gait analysis with an Inertial Measurement Unit (IMU) sensor
Gait analysis with reflective markers and pressure sensors
Time frame: Throughout study completion (an average of 2h)
Comparison of walking speed measured with REEV SENSE with reference method
Time frame: Throughout study completion (an average of 2h)
Comparison of KPP measured with REEV SENSE with reference method.
Time frame: Throughout study completion (an average of 2h)
Comparison of walking cadence measured with REEV SENSE with reference method
Time frame: Throughout study completion (an average of 2h)
Comparison of stride length measured with REEV SENSE with reference method
Time frame: Throughout study completion (an average of 2h)
Comparison of swing time measured with REEV SENSE with reference method
Time frame: Throughout study completion (an average of 2h)
Comparison of stance time measured with REEV SENSE with reference method
Time frame: Throughout study completion (an average of 2h)
Comparison of stance symmetry measured with REEV SENSE with reference method
Time frame: Throughout study completion (an average of 2h)
Comparison of knee flexion measured with REEV SENSE with reference method
Time frame: Throughout study completion (an average of 2h)
Comparison of ankle flexion angle measured with REEV SENSE with reference method
REEV LLC
Industry
Validation of REEV SENSE Biomarkers Precision for Gait Analysis in Subjects With Post-stroke Gait Impairment
Acronym: SENS-AG
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.
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