Fall Risk Assessment With an Innovative Device for Quantifying Gait and Static Balance in Geriatric Consultation

NCT ID: NCT06535477

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-28
• Study Completion Date: 2027-01-23

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.

Conditions

Risk of Falling in the Elderly

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Fall risk assessment

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gérond'if

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Pariel, MD

Role: STUDY_CHAIR

Ambulatory Care Department, Charles Foix Hospital

Lina MICHELET, MD

Role: STUDY_DIRECTOR

Abilycare

Locations

Ambulatory Care Department, Charles Foix Hospital

Ivry-sur-Seine, IIe-de-France, France

Site Status: RECRUITING

Countries

France

Central Contacts

Isabelle DUFOUR

Role: CONTACT

isabelle.dufour@gerondif.org

+ 33 (0) 185781011

Albatoul ZAKARIA, Ph.D

Role: CONTACT

albatoul.zakaria@gerondif.org

+33 (0) 185781010

Facility Contacts

Sylvie Pariel, MD

Role: primary

sylvie.pariel@aphp.fr

+33 (0) 149594385

Other Identifiers

2024-A00055-42

Identifier Type: -

Identifier Source: org_study_id