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

Primary Purpose

Fall, Fall Patients, Osteoporosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FeetMe® Monitor
Sponsored by
FeetMe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fall focused on measuring FeetMe, Insoles, Fall, Osteoporosis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Osteoporotic patients

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 15, 2021
Last Updated
June 6, 2023
Sponsor
FeetMe
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1. Study Identification

Unique Protocol Identification Number
NCT05155761
Brief Title
Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
Acronym
FAIR
Official Title
Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
November 25, 2024 (Anticipated)
Study Completion Date
November 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FeetMe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fall, Fall Patients, Osteoporosis
Keywords
FeetMe, Insoles, Fall, Osteoporosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osteoporotic patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
FeetMe® Monitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Assess walking speed decrease during 6MWT at baseline
Time Frame
at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Service de Rhumatologie, Hôpital Cochin, Assistance Publique - Hôpitaux de
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine Briot, Dr.
Phone
01 58 41 26 06
Email
karine.briot@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

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

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