Validation Study : FeetMe® Monitor Insoles for the Evaluation of Gait Speed

Healthy Clinical Trial

Official title:

Reliability and Competing Validity of the FeetMe Monitordevice® Measurement of the Spatial-temporal Parameters of the gaitRite System® in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268017
• Other study ID #: FTM_HEALTHY_01
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: October 2, 2018

Study information

• Verified date: February 2020
• Source: FeetMe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2, 2018
• Est. primary completion date: October 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• FeetMe 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

Locations

Country	Name	City	State
France	Fédération de Rééducation Neurolocomotrice, Laboratoire ARM - Hôpital Henri MONDOR, Assistance Publique - Hôpitaux de Paris	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
FeetMe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Velocity measured through FeetMe Monitor device and GaitRit		1 day
Secondary	Stride length measured through FeetMe Monitor device and GaitRite		1 day
Secondary	Cadence measured through FeetMe Monitor device and GaitRite		1 day
Secondary	Stance phase measured through FeetMe Monitor device and GaitRite		1 day
Secondary	Swing phase measured through FeetMe Monitor device and GaitRite		1 day
Secondary	Stride duration measured through FeetMe Monitor device and GaitRite		1 day