Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- FeetMe
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Time Frame: at baseline
Assess walking speed decrease during 6MWT at baseline
Secondary Outcomes
No secondary outcomes reported