Healthy
Conditions
Keywords
Gait analysis, FeetMe®, GaitRite®, Healthy, Validation
Brief summary
The aim of this study is to validate a smart insoles system in comparison to the gold-standard GaitRite in a healthy population. The device evaluate gait parameters in real time thanks to an embedded algorithm based on the processing of inertial measurement unit and 19 sensors signals. At D0 and D7, the volunteer is evaluated by both the GaitRite® system and the FeetMe Monitor® system simultaneously. Healthy volunteers have two measurements 7 days apart. The volunteer repeats 5 trials at a comfortable speed on the GaitRite® mat while wearing the FeetMe® insoles. Each measurement is repeated by 4 different operators. A total of 20 trials are made by the volunteer.
Interventions
DEVICEFeetMe Monitor
For gait parameters' evaluation, the investigator asks the participant to move in a straight line over a 10-meter mat. The participant had to start the feet in line and then start walking at a comfortable speed. During this time, the investigator records the gait parameters from the FeetMe Monitor® and Gaitrite® system. An operator asked the patient to repeat 3 trials. The same sequence was repeated by three other operators. The same measurement is done 7 days later. A questionnaire is given to assess the ergonomics of the device
Sponsors
FeetMe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Have more than 18 years old * Don't be pregnant or breast feeding
Exclusion criteria
* Be part of another study * Not be able to give consent * Not have access to social security
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Velocity measured through FeetMe Monitor device and GaitRit | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Stride length measured through FeetMe Monitor device and GaitRite | 1 day |
| Cadence measured through FeetMe Monitor device and GaitRite | 1 day |
| Stance phase measured through FeetMe Monitor device and GaitRite | 1 day |
| Swing phase measured through FeetMe Monitor device and GaitRite | 1 day |
| Stride duration measured through FeetMe Monitor device and GaitRite | 1 day |
Countries
France
Outcome results
None listed