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

NCT ID: NCT05155761

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-25
• Study Completion Date: 2024-11-25

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.

Conditions

Fall; Fall Patients; Osteoporosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Osteoporotic patients

Group Type: EXPERIMENTAL

FeetMe® Monitor

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FeetMe

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de Rhumatologie, Hôpital Cochin, Assistance Publique - Hôpitaux de

Paris, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Karine Briot, Dr.

Role: primary

karine.briot@aphp.fr

01 58 41 26 06

Other Identifiers

FTM_FAIR

Identifier Type: -

Identifier Source: org_study_id