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

NCT05574309 | Completed

• 2 other identifiers: 21CH030ANSM
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall Patients; Frailty

Keywords

fall prevention; older; inertial sensors; dissociation of girdles

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• assessment of patients' frailty status

  at the inclusion

• assessment of patients' frailty status

  During walking test

• Composite outcome : measurement of various walking quantitative parameters

  at the inclusion

• Composite outcome : measurement of various walking quantitative parameters

  During walking test

Study Arms (2)

Fallers

SHAM COMPARATOR

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; Device: GAITRite Device

non fallers

OTHER

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; Device: GAITRite Device

Interventions

Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer DEVICE

Dissociation measure of pelvic and scapular girdles by 2 inertial sensors of accelerometer type (IMU BNO055) during a 10 m walking test

Fallers; non fallers

GAITRite Device DEVICE

Walking parameter measured during a 10 m walking test with GaitRite device

Fallers; non fallers

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas CELARIER, PhD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Case-control study from the clinical gerontology service and the PROOF cohort. Cases: patients who fell (= at least one fall in the last 12 months) mainly from the clinical from the clinical gerontology department. Controls: patients/subjects who have not fallen, mainly from the PROOF cohort.

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 10, 2022
• Study Start: January 30, 2023
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)