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

NCT05155761 | Unknown

• 1 other identifier: FTM_FAIR
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

FeetMe; Insoles; Fall; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Osteoporotic patients

EXPERIMENTAL

Device: FeetMe® Monitor

Interventions

FeetMe® Monitor 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.

Osteoporotic patients

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FeetMe: lead

Study Sites (1)

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

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: December 14, 2021
• Study Start: March 25, 2021
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

FR (1)