Fall Risk Assessment With an Innovative Device for Quantifying Gait and Static Balance in Geriatric Consultation
- Conditions
- Risk of Falling in the Elderly
- Registration Number
- NCT06535477
- Lead Sponsor
- Gérond'if
- Brief Summary
The main objective of this monocentric, non-randomized, prospective study was to evaluate the predictive capacity of a balance score based on spatio-temporal parameters of postural balance.
- Detailed Description
Patient recruitment will take place at one center. The inclusion period is 6 months and the participation period for each subject will be 12 months with 3 visits: initial visit, telephone visit at 6 months, M12 consultation visit, and the end-of-study visit.
Consent will be obtained prior to participation, and the following data will be collected during the visits: Demographic data (age, gender), weight, height, geriatric assessment. Current treatment (molecules, date of introduction, dosage). Biological data: Albumin, Pre-Albumin, Creatinine, Hemoglobin, Vitamin D.
Static balance parameters via AbilyCare (static balance test, inspired by the Romberg test, on a balance platform, 30 seconds eyes open then 30 seconds eyes closed).
The total duration of the research is 18 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Balance score 12 months The balance score, based on a learning model incorporating spatio-temporal parameters of pressure center displacement. These parameters include amplitude along the anterior-posterior and medio-lateral axes, surface area covered, and displacement speed. The overall score is calculated on the basis of model-building data from profiles of people with and without previous falls. This score, evaluated from 0 to 100, indicates the level of balance, with a score of 99 representing optimal balance. The lower the score, the more precarious the balance, thus approximating a potential faller profile.
- Secondary Outcome Measures
Name Time Method Evaluation of the association between each static balance indicator and fall occurrence 12 months The following indicators will be analyzed:
* Oscillation area in mm² : Area covered by the displacement of the center of pressure, calculated by tracing the trajectory of the center of pressure and determining the minimum area that encompasses all these trajectories (contained within an ellipse of 90% confidence).
* Sway density in seconds : Duration (travel time) during the entire sequence (30s) when the center of pressure remains in the vicinity (radius less than 5 mm) of each calculated point of the center of pressure's position.
* Lateral variance in mm² : Extent of variability in the position of the center of pressure around an average position on the medial-lateral axis.
* Average oscillation speed in mm/s : Average speed of displacement of the center of pressure in all directions.
Trial Locations
- Locations (1)
Ambulatory Care Department, Charles Foix Hospital
🇫🇷Ivry-sur-Seine, IIe-de-France, France