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

Osteoporosis Clinical Trial

— FAIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155761
• Other study ID #: FTM_FAIR
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: November 25, 2024

Study information

• Verified date: June 2023
• Source: FeetMe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 25, 2024
• Est. primary completion date: November 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

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.

Related Conditions & MeSH terms

• Fall
• Fall Patients
• Osteoporosis

Intervention

Device:
• FeetMe® Monitor
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.

Locations

Country	Name	City	State
France	Service de Rhumatologie, Hôpital Cochin, Assistance Publique - Hôpitaux de	Paris

Sponsors (1)

Lead Sponsor	Collaborator
FeetMe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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