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Clinical Trials/NCT04266743
NCT04266743
Completed
Not Applicable

FeetMe® Monitor Connected Insoles Are a Valid and Reliable Alternative for the Evaluation of Gait Speed After Stroke

FeetMe1 site in 1 country30 target enrollmentOctober 29, 2018
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ConditionsStrokeGait Disorders, Neurologic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
FeetMe
Enrollment
30
Locations
1
Primary Endpoint
Velocity measured through FeetMe Monitor device and GaitRite
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 for a pathologic gait. 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 patient is evaluated by both the GaitRite® system and the FeetMe Monitor® system simultaneously. Hemiparetic patients have two measurements 7 days apart. The patient 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 patient.

Registry
clinicaltrials.gov
Start Date
October 29, 2018
End Date
March 18, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
FeetMe
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Have more than 18 years old
  • •Don't be pregnant or breast feeding
  • •Have a stroke for more than 6 months

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 GaitRite

Time Frame: 1 day

Secondary Outcomes

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

Study Sites (1)

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