Identifying fall risk factors in patients with osteoporosis using connected insoles
Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
This study is trying to find out how walking patterns can help predict fall risks in older adults with osteoporosis by having them wear special insoles at home for a few days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | FeetMe Industry-sponsored |
| Locations | 1 site (Paris) |
| Trial ID | NCT05155761 on ClinicalTrials.gov |
What this trial studies
This study aims to identify gait parameters that are associated with fall risk in patients aged 60 and older who have osteoporosis and a high risk of fractures. Participants will wear FeetMe® Monitor Insoles at home for 3 to 10 days after attending three clinical visits at Cochin hospital, where various tests will be conducted to assess their fall risk. The data collected from the insoles will reflect the patients' walking patterns in their daily lives, providing insights into their risk of falling.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 60 and above with a history of falls and osteoporosis.
Not a fit: Patients with cognitive deficits or those unable to participate due to legal or administrative reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved fall prevention strategies for patients with osteoporosis.
How similar studies have performed: While the use of connected devices for monitoring gait is gaining traction, this specific approach using FeetMe® Insoles is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Paris
- Service de Rhumatologie, Hôpital Cochin, Assistance Publique - Hôpitaux de — Paris, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.