FeetMe Evaluation®
Introduction
FeetMe Evaluation® is a mobile application to visualize gait spatio-temporal parameters combined with a FeetMe device. The device is used in real world non invasively and collect and analyse gait spatio temporal parameters and their variability thanks to embedded algorithms and wireless connectivity.
Applications
FeetMe® Evaluation Mobility in the solution that brings together the connected insoles FeetMe® Insole, and the data visualization software FeetMe® Evaluation. The solution is dedicated to gait and posture analysis in real world setting.
How does it work?
Worn by the patient, FeetMe® Insole insoles allow the data collection of more than 20 metrics based and pressure and motion sensors embedded in the insoles.
The data collected is transmitted to FeetMe® Evaluation visualization software that allows:
- Gait spatio-temporal parameters visualisation;
- Gait parameters variability analysis during a gait test;
- Multiple records data comparison;
- Data historic conservation.
Targeted Pathologies
FeetMe® Evaluation Mobility provides key evaluations to assess mobility in different settings:
| Examples (non-comprehensive list) | |
|---|---|
| Multiple Sclerosis | Regular home monitoring of gait disorders and disease evolution. |
| Parkinson | Regular home monitoring of gait disorders and disease evolution. Freezing of gait home detection. |
| Cerebral Palsy | Pre and post rehabilitation training evaluations in walking CP patients. |
| Obesity | Objective feedback on behavioral therapy and motivationnal support for physical activity among obese patients. |
| Sarcopenia | Real word gait fragility and fall risk. Efficacy measurement of rehabilitation treatments. |
| Alzheimer | Early detection of cognitive decline through gait instability in dual task. |
| Artherioathy | Gait disorders detection and walking perimeter abnormal decrease. |
| COPD | Quantifed 6 min gait analysis test. |
| Diabetic Foot | Abnormal plantar pressure detection in real real world setting among patient suffering from diabetic neuropathy. |
For other pathologies that impact mobility and non listed here, you can contact us to submit a research project: Contact Us
Benefits
FeetMe® Evaluation Mobility solution brings clearly identified added value for its customers:
| Patient | Hospitals | Pharma | Research | |
|---|---|---|---|---|
| Open data | ||||
| Real time objective data | ||||
| Collect real world data | ||||
| Help switching treatments if needed | ||||
| Helps to identify different potential contraindications | ||||
| Evaluate the impact of drug treatments | ||||
| Evaluate the efficacy of care | ||||
| Collect safety related information | ||||
| Collect information on your relative health status | ||||
| Collect information on patient mobility | ||||
| Save medical time | ||||
| High quality real world data on treatments efficacy |
Clinical Tests
Our gait tests with one FeetMe® Evaluation Mobility:
- Home assesment
- 6 min walking test
- 400 meters test
- 10 meters walk test
- TUG
- Posturography
Metrics and technical specifications
More than 20 metrics are calculated for every step with FeetMe® Insole:
- Stride length
- Walking speed
- Width motion
- Cadence
- Stride time
- Single support time
- Swing time
- Double support time
- Pressure distribution
- Stride length difference
- Strides time difference
- Distance traveled
- Support asymetry
- Trajectory center of pressure
Scientific validation / Data export
Our measurements have been scientifically validated in clinical setting. Our customers can easily access our data and the data can be customized based on customers needs.
Technical validation (in french)
For further information or studies: contact us
Regulatory requirements
FeetMe Quality Management System has certified NF EN ISO 13485:2016 & ISO 9001:2015
FeetMe Evaluation is a medical device in class Im:
- Compliant with Directive 93/42/CEE (in transition with the medical device regulation 2017/745)
- Compliant with CEI 60601-1 :2006 (Basic safety & essential performance of Medical electrical equipment) & CEI 60601-1-11 :2010 (used in the home healthcare environment)
- IP54
- Compliant with ISO 62304:2006 (Software life-cycle processes)
- Compliant with ISO 62366:2008 (Usability engineering)
-
Compliant with European Regulation n° 2016/679 GDPR, and the French law n°78-17 January, 6 1978 concerning IT, files and freedom
Support and questions
You can download user manuals and support documents on the page Support & Downloads.
You can also consult Frequently asked questions.
You can also contact us.