Understanding the Measurement of Girdle Dissociation in the Fall of the Older People Subject. (EPAD-C2)

Understanding the Measurement of Girdle Dissociation in the Fall of the Older People Subject. Case-control Study

Falls, especially in the older people, are frequent with potential serious consequences. The strategy for preventing falls involves detecting the fall risk. Current tests to determine the risk of falling are too late indicators of gait disorder. Loss of gait dissociation is an element associated with the mechanism of the fall and appears earlier. Its diagnosis is particularly important as it is a reversible impairment if rehabilitation interventions can be proposed to correct this anomaly.

Study Overview

• Status: Completed
• Conditions: Frailty; Fall Patients
• Intervention / Treatment: Device: Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer; Device: GAITRite Device

Detailed Description

The purpose of this study is to validate the device's measurement of belt dissociation in a discriminating manner between fallers and nonfallers.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed and signed a written consent form.
• Affiliated or eligible to a health insurance system.
• Being able to give their consent to participate.
• For fallers: had at least one fall in the previous year.
• For non fallers: not had a fall in the previous year.

Exclusion Criteria:

• Patients suffering from a neurological or articular pathology responsible for gait disorders (Parkinson's disease, hemiplegia, narrow lumbar canal, peripheral neuropathy, vestibular pathology, chronic inflammatory rheumatism…).
• Patients who have undergone joint surgery of the lower limbs during the year.
• Patients walking with a walker.
• Patients with an internal electronic device (pacemaker, neurostimulator, insulin pump…).
• Patients taking long-term neuroleptics.
• Patients with advanced major cognitive impairment (according to the Clinical Dementia Rating Protocol >1).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Fallers; population of patients who have fallen from the clinical gerontology department of the CHU of Saint-Etienne and from the PROOF cohort and subjects of the Office Stéphanois pour les Ainés (OSAP)	Device: Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer; Dissociation measure of pelvic and scapular girdles by 2 inertial sensors of accelerometer type (IMU BNO055) during a 10 m walking test; Device: GAITRite Device; Walking parameter measured during a 10 m walking test with GaitRite device
Other: non fallers; population of patients who did not fall from the clinical gerontology department of the CHU of Saint-Etienne and from the PROOF cohort and subjects of the Office Stéphanois pour les Ainés (OSAP)	Device: Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer; Dissociation measure of pelvic and scapular girdles by 2 inertial sensors of accelerometer type (IMU BNO055) during a 10 m walking test; Device: GAITRite Device; Walking parameter measured during a 10 m walking test with GaitRite device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure of position of the pelvic and scapular girdles	The position of the pelvic and scapular girdles will be measured by the angle (in degrees) between the two girdles C7 and L5 in the sagittal plane during a 10 meters walking test. The angle will be measured by two inertial sensors of accelerometer type (IMU BNO055).	During walking test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of patients' frailty status	Patients' frailty status will be assessed using the Fried score	at the inclusion
assessment of patients' frailty status	Patients' frailty status will be assessed using the Fried score	During walking test
Composite outcome : measurement of various walking quantitative parameters	Composite outcome will be measured with the following quantitative parameters using the GAITRite device: the parameters of walking speed (m/s), variability (%), length (m), width (cm), symmetry (m), cadence (steps/min) and step cycle time (s).	at the inclusion
Composite outcome : measurement of various walking quantitative parameters	Composite outcome will be measured with the following quantitative parameters using the GAITRite device: the parameters of walking speed (m/s), variability (%), length (m), width (cm), symmetry (m), cadence (steps/min) and step cycle time (s).	During walking test

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Thomas CELARIER, PhD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): January 17, 2024
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: fall prevention; older; inertial sensors; dissociation of girdles
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Frailty; Dissociative Disorders
• Other Study ID Numbers: 21CH030; ANSM (Other Identifier: 2026-A00172-49)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No