NCT04266743

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

January 28, 2020

Last Update Submit

February 11, 2020

Conditions

StrokeGait Disorders, Neurologic

Keywords

Gait analysisStrokeFeetMeGaitRite

Outcome Measures

Primary Outcomes (1)

  • Velocity measured through FeetMe Monitor device and GaitRite

    1 day

Secondary Outcomes (5)

  • 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

Study Arms (1)

Hemiparetic patient

EXPERIMENTAL

patients who had a stroke at least 6 months before inclusion

Device: FeetMe Monitor

Interventions

FeetMe MonitorDEVICE

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

Hemiparetic patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Be part of another study
  • Not be able to give consent
  • Not have access to social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Créteil, 94000, France

Location

MeSH Terms

Conditions

StrokeGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2020

First Posted

February 12, 2020

Study Start

October 29, 2018

Primary Completion

March 18, 2019

Study Completion

March 18, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)