Understanding the Measurement of Girdle Dissociation in the Fall of the Older People Subject.

Not Applicable

Completed

• Conditions: Frailty; Fall Patients
• Interventions: Device: Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer; Device: GAITRite Device

• Registration Number: NCT05574309
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Study Start: 2023-01-30
• Primary Completion: 2024-01-17
• Status Verified: 2024-04
• Study Completion: 2025-01-17
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fallers	GAITRite Device	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)
Fallers	Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer	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)
non fallers	GAITRite Device	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)
non fallers	Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer	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)

Primary Outcome Measures

Name	Time	Method
measure of position of the pelvic and scapular girdles	During walking test	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).

Secondary Outcome Measures

Name	Time	Method
Composite outcome : measurement of various walking quantitative parameters	During walking test	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).
assessment of patients' frailty status	During walking test	Patients' frailty status will be assessed using the Fried score

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France