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Completed

NCT Number: NCT04266743

FeetMe® Monitor: Alternative for the Evaluation of Gait Speed After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fédération de Rééducation Neurolocomotrice, Laboratoire ARM - Hôpital Henri MONDOR, Assistance Publique - Hôpitaux de Paris

Créteil, 94000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FeetMe Monitor

Device

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

Primary outcomes

  1. Velocity measured through FeetMe Monitor device and GaitRite

    Time frame: 1 day

Secondary outcomes

  1. Stride length measured through FeetMe Monitor device and GaitRite

    Time frame: 1 day

  2. Cadence measured through FeetMe Monitor device and GaitRite

    Time frame: 1 day

  3. Stance phase measured through FeetMe Monitor device and GaitRite

    Time frame: 1 day

  4. Swing phase measured through FeetMe Monitor device and GaitRite

    Time frame: 1 day

  5. Stride duration measured through FeetMe Monitor device and GaitRite

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

FeetMe

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2020
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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