Gait Disorders, Neurologic, Stroke
Conditions
Keywords
Stroke, Gait analysis, Accelerometer, Gait impairment
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.
Interventions
DEVICEREEV SENSE
Gait analysis with an Inertial Measurement Unit (IMU) sensor
DEVICEMotion capture system
Gait analysis with reflective markers and pressure sensors
Sponsors
REEV LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking speed measure precision | Throughout study completion (an average of 2h) | Comparison of walking speed measured with REEV SENSE with reference method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Walking cadence measure precision = precision of the number of steps per minute | Throughout study completion (an average of 2h) | Comparison of walking cadence measured with REEV SENSE with reference method |
| Stride length measure precision | Throughout study completion (an average of 2h) | Comparison of stride length measured with REEV SENSE with reference method |
| Swing time measure precision | Throughout study completion (an average of 2h) | Comparison of swing time measured with REEV SENSE with reference method |
| KPP (Knee Position Predictor) measure precision = precision of the predicted angle of knee sagittal flexion in the next 200ms | Throughout study completion (an average of 2h) | Comparison of KPP measured with REEV SENSE with reference method. |
| Stance symmetry measure precision = precision of the % of unilateral stance time predominance (right or left) compared to total bilateral stance time (right and left) | Throughout study completion (an average of 2h) | Comparison of stance symmetry measured with REEV SENSE with reference method |
| Knee flexion angle measure precision in sagittal plan | Throughout study completion (an average of 2h) | Comparison of knee flexion measured with REEV SENSE with reference method |
| Ankle flexion angle measure precision in sagittal plan | Throughout study completion (an average of 2h) | Comparison of ankle flexion angle measured with REEV SENSE with reference method |
| Stance time measure precision | Throughout study completion (an average of 2h) | Comparison of stance time measured with REEV SENSE with reference method |
Countries
United States
Outcome results
None listed