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

FeetMe

Status

Enrolling

Conditions

Osteoporosis

Fall Patients

Fall

Treatments

Device: FeetMe® Monitor

Study type

Interventional

Funder types

Industry

Identifiers

NCT05155761

FTM_FAIR

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.