Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)

Study Overview
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Brief Summary
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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.

Official Title
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Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)

Conditions
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Fall, Fall Patients, Osteoporosis

Intervention / Treatment
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* Device: FeetMe® Monitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteoporotic patients<br> | Device: FeetMe® Monitor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FeetMe, Insoles, Fall, Osteoporosis