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

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

Non Recruiting
60 years and older
All
Phase N/A

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Overview

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.

Eligibility

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.

Study details
    Fall
    Fall Patients
    Osteoporosis

NCT05155761

FeetMe

20 August 2025

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