Assessing fall risk in elderly patients using a new device
Fall Risk Assessment With an Innovative Device for Quantifying Gait and Static Balance in Geriatric Consultation
This study is testing a new device to see if it can help identify fall risks in older adults by measuring their balance and walking patterns over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 65 Years to 95 Years |
| Sex | All |
| Sponsor | Gérond'if Academic / other |
| Locations | 1 site (Ivry-sur-Seine, IIe-de-France) |
| Trial ID | NCT06535477 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a novel device designed to quantify gait and static balance in elderly patients at risk of falling. It involves a monocentric, non-randomized, prospective approach where participants will undergo a series of assessments over a 12-month period, including demographic data collection and balance tests. The study will focus on measuring spatio-temporal parameters of postural balance to develop a predictive balance score. Participants will have three visits: an initial consultation, a follow-up telephone visit at six months, and a final consultation at twelve months.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals with a GIR score of 4 or higher and an MMSE score of 18 or above.
Not a fit: Patients with major systemic pathologies or advanced neurodegenerative diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved fall risk assessments and preventive strategies for elderly patients.
How similar studies have performed: While similar studies have explored fall risk assessments, this specific approach using a novel device is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject with a "Autonomie, Gérontologie, Groupes IsoRessources" (GIR) score ≥ 4 at the time of consultation * Subject presenting an The mini mental status exam (MMSE) score ≥ 18 at the time of consultation * Subject agreeing in writing (consent), after having been informed and given a reasonable period of reflection, to participate in the study * Subject affiliated to a social security scheme. Exclusion Criteria: * Subjects with a major or systemic pathology likely to significantly impair motor skills (inability to perform a 10m walking test without assistance, inability to perform a balance test on a scale without assistance (30 seconds eyes open / 30 seconds eyes closed), * Subject with an advanced neurodegenerative pathology (Alzheimer, Parkinson, etc.) deemed incompatible with the objectives of the study by the investigator, * Subjects with a history of disabling cerebrovascular accident, * Subject with an active disabling cancer, * Subjects with severe psychiatric disorders affecting their ability to perform walking and balance tests and/or answer study questionnaires, * Subjects benefiting from a technical aid for walking and balance such as a cane, walker, etc. (only orthopedic insoles and shoes are accepted); subjects with a total hip or knee prosthesis are included, * Subject having been hospitalized for a fall in the last 3 months prior to inclusion, * Subject unable to understand the purpose of the research, answer questions and give his/her decision to participate in the study, * Subject already included in another research study involving the human body, * Subject not affiliated to a social security scheme or not benefiting from such a scheme. * Person deprived of liberty by judicial or administrative decision * Person of full age subject to a legal protection measure (guardianship, curatorship, safeguard of justice) or unable to express consent.
Where this trial is running
Ivry-sur-Seine, IIe-de-France
- Ambulatory Care Department, Charles Foix Hospital — Ivry-sur-Seine, IIe-de-France, France (Recruiting)
Study contacts
- Study coordinator: Isabelle DUFOUR
- Email: isabelle.dufour@gerondif.org
- Phone: + 33 (0) 185781011
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.