Back to resultsFeetMe® Monitor: Alternative for the Evaluation of Gait Speed After Stroke
Primary Purpose
Stroke, Gait Disorders, Neurologic
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FeetMe Monitor
Sponsored by
About this trial
This is an interventional basic science trial for Stroke focused on measuring Gait analysis, Stroke, FeetMe, GaitRite
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
Sites / Locations
- Fédération de Rééducation Neurolocomotrice, Laboratoire ARM - Hôpital Henri MONDOR, Assistance Publique - Hôpitaux de Paris
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hemiparetic patient
Arm Description
patients who had a stroke at least 6 months before inclusion
Outcomes
Primary Outcome Measures
Velocity measured through FeetMe Monitor device and GaitRite
Secondary Outcome Measures
Stride length measured through FeetMe Monitor device and GaitRite
Cadence measured through FeetMe Monitor device and GaitRite
Stance phase measured through FeetMe Monitor device and GaitRite
Swing phase measured through FeetMe Monitor device and GaitRite
Stride duration measured through FeetMe Monitor device and GaitRite
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04266743
Brief Title
FeetMe® Monitor: Alternative for the Evaluation of Gait Speed After Stroke
Official Title
FeetMe® Monitor Connected Insoles Are a Valid and Reliable Alternative for the Evaluation of Gait Speed After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
March 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FeetMe
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Gait Disorders, Neurologic
Keywords
Gait analysis, Stroke, FeetMe, GaitRite
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hemiparetic patient
Arm Type
Experimental
Arm Description
patients who had a stroke at least 6 months before inclusion
Intervention Type
Device
Intervention Name(s)
FeetMe Monitor
Intervention Description
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 Outcome Measure Information:
Title
Velocity measured through FeetMe Monitor device and GaitRite
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Stride length measured through FeetMe Monitor device and GaitRite
Time Frame
1 day
Title
Cadence measured through FeetMe Monitor device and GaitRite
Time Frame
1 day
Title
Stance phase measured through FeetMe Monitor device and GaitRite
Time Frame
1 day
Title
Swing phase measured through FeetMe Monitor device and GaitRite
Time Frame
1 day
Title
Stride duration measured through FeetMe Monitor device and GaitRite
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fédération de Rééducation Neurolocomotrice, Laboratoire ARM - Hôpital Henri MONDOR, Assistance Publique - Hôpitaux de Paris
City
Créteil
ZIP/Postal Code
94000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
FeetMe® Monitor: Alternative for the Evaluation of Gait Speed After Stroke
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