Clinical trial NCT06535477: Fall Risk Assessment With an Innovative Device for Quantifying Gait and Static Balance in Geriatric Consultation
Official title: Fall Risk Assessment With an Innovative Device for Quantifying Gait and Static Balance in Geriatric Consultation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Risk of Falling in the Elderly
Keywords: Falls
static balance
Spatio temporal parameters
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Assessing frailty in elderly patients using Fried Frailty and "Short Emergency Geriatric Assessment" scales combined with measurement - via the AbilyCare device - of the two markers of balance and gait
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Balance score
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of the association between each static balance indicator and fall occurrence
timeFrame: 12 months
Other outcomes:
measure: Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score
timeFrame: 12 months
measure: Assessment of physical frailty according Fried scale
timeFrame: 12 months
measure: Assessment of Failty status using the Short Emergency Geriatric Assessment (SEGA)
timeFrame: 12 months
measure: Assessment of the degree of autonomy according AGGIR score
timeFrame: 12 months
Locations:
city: Ivry-sur-Seine
country: France
facility: Ambulatory Care Department, Charles Foix Hospital
state: IIe-de-France
Study officials:
affiliation: Ambulaoty Care Department, Charles Foix Hospital
name: Sylvie Pariel, MD
role: STUDY_CHAIR
References: