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Clinical Trials/NCT04268017
NCT04268017
Completed
Not Applicable

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

FeetMe1 site in 1 country30 target enrollmentSeptember 17, 2018
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ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
FeetMe
Enrollment
30
Locations
1
Primary Endpoint
Velocity measured through FeetMe Monitor device and GaitRit
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 17, 2018
End Date
October 2, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group

Investigators

Sponsor
FeetMe
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Velocity measured through FeetMe Monitor device and GaitRit

Time Frame: 1 day

Secondary Outcomes

  • Cadence measured through FeetMe Monitor device and GaitRite(1 day)
  • Stride length 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)

Study Sites (1)

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