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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gait analysis | Experimental | Gait analysis with the investigational and the reference devices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REEV SENSE | Device | Gait analysis with an Inertial Measurement Unit (IMU) sensor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Walking speed measure precision | Comparison of walking speed measured with REEV SENSE with reference method | Throughout study completion (an average of 2h) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Walking cadence measure precision = precision of the number of steps per minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MIT Center for Clinical and Translational Research | Cambridge | Massachusetts | 02139 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Motion capture system |
| Device |
Gait analysis with reflective markers and pressure sensors |
|
Comparison of walking cadence measured with REEV SENSE with reference method |
| Throughout study completion (an average of 2h) |
| Stride length measure precision | Comparison of stride length measured with REEV SENSE with reference method | Throughout study completion (an average of 2h) |
| Swing time measure precision | Comparison of swing time measured with REEV SENSE with reference method | Throughout study completion (an average of 2h) |
| Stance time measure precision | Comparison of stance time measured with REEV SENSE with reference method | Throughout study completion (an average of 2h) |
| 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) |
| 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) |
| 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) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |