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

NCT06535477 | Terminated DMC

• 1 other identifier: 2024-A00055-42
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Risk of Falling in the Elderly

Keywords

Falls; static balance; Spatio temporal parameters

Outcome Measures

Primary Outcomes (1)

• Balance score

  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.

  12 months

Secondary Outcomes (1)

• Evaluation of the association between each static balance indicator and fall occurrence

  12 months

Other Outcomes (4)

• Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score

  12 months

• Assessment of physical frailty according Fried scale

  12 months

• Assessment of Failty status using the Short Emergency Geriatric Assessment (SEGA)

  12 months

Interventions

Fall risk assessment DEVICE

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

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Gérond'if: lead

Study Sites (1)

Ambulatory Care Department, Charles Foix Hospital

Ivry-sur-Seine, IIe-de-France, 94200, France

Location

Study Officials

• Sylvie Pariel, MD

  Ambulatory Care Department, Charles Foix Hospital

  STUDY CHAIR

• Lina MICHELET, MD

  Abilycare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: August 2, 2024
• Study Start: July 26, 2024
• Primary Completion: February 26, 2026
• Study Completion: February 26, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)