Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device) (FAIR)
Primary Purpose
Fall, Fall Patients, Osteoporosis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FeetMe® Monitor
Sponsored by
About this trial
This is an interventional basic science trial for Fall focused on measuring FeetMe, Insoles, Fall, Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- male and female subjects aged 60 years and above
- with a high fracture and fall risk defined by osteoporosis (low-trauma fracture within the last 5 years and/or osteoporotic bone density)
- a fall within the last year, who own a smartphone.
Exclusion Criteria:
- cognitive deficit or concomitant disorder limiting communication or participation in the study
- simultaneous participation in another study
- deprivation of liberty due to a legal or administrative decision
- patients receiving psychiatric care
- adults beyond the age of majority under legal protection measures or unable to express their consent
- patients admitted to a health or social establishment for reasons other than research.
Sites / Locations
- Service de Rhumatologie, Hôpital Cochin, Assistance Publique - Hôpitaux deRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Osteoporotic patients
Arm Description
Outcomes
Primary Outcome Measures
To assess how a walking speed decrease at baseline during a 6MWT as measured by the connected Insoles, connected insoles devices, has an effect on risk of fall in subjects with osteoporosis.
Assess walking speed decrease during 6MWT at baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05155761
Brief Title
Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
Acronym
FAIR
Official Title
Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
November 25, 2024 (Anticipated)
Study Completion Date
November 25, 2024 (Anticipated)
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 objective of this study is to determine which gait parameters measured at home using e FeetMe® Insoles are associated with a risk for falls in a patient population suffering from osteoporosis and a higher with high risk of fractures and falls.
Each patient will be asked to go to 3 visits at the Cochin hospital, and to wear the soles after each of these visits during 3 days, at home, to record the data, so that it reflects walking patterns of the patient in his/her daily life and activities.
At the eachvisit, clinical tests to assess fall risk will be performed (Timed Up and Go test, one foot stance, Short Physical Performance Battery and 6 minutes walking test ).
The patients will be supplied with a pair of FeetMe® Monitor Insoles, return home and walking parameters will be recorded for 3 to 10 consecutive days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fall, Fall Patients, Osteoporosis
Keywords
FeetMe, Insoles, Fall, Osteoporosis
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
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Osteoporotic patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
FeetMe® Monitor
Intervention Description
Each patient will be asked to go to 3 visits at the Cochin hospital, and to wear the soles after each of these visits during 3 days, at home, to record the data, so that it reflects walking patterns of the patient in his/her daily life and activities.
At each visit, clinical tests to assess fall risk will be performed (Timed Up and Go test, one foot stance, Short Physical Performance Battery and 6 minutes walking test ).
The patients will be supplied with a pair of FeetMe® Monitor insoles, return home and walking parameters will be recorded for 3 to 10 consecutive days.
Primary Outcome Measure Information:
Title
To assess how a walking speed decrease at baseline during a 6MWT as measured by the connected Insoles, connected insoles devices, has an effect on risk of fall in subjects with osteoporosis.
Description
Assess walking speed decrease during 6MWT at baseline
Time Frame
at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male and female subjects aged 60 years and above
with a high fracture and fall risk defined by osteoporosis (low-trauma fracture within the last 5 years and/or osteoporotic bone density)
a fall within the last year, who own a smartphone.
Exclusion Criteria:
cognitive deficit or concomitant disorder limiting communication or participation in the study
simultaneous participation in another study
deprivation of liberty due to a legal or administrative decision
patients receiving psychiatric care
adults beyond the age of majority under legal protection measures or unable to express their consent
patients admitted to a health or social establishment for reasons other than research.
Facility Information:
Facility Name
Service de Rhumatologie, Hôpital Cochin, Assistance Publique - Hôpitaux de
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine Briot, Dr.
Phone
01 58 41 26 06
Email
karine.briot@aphp.fr
12. IPD Sharing Statement
Learn more about this trial
Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
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