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

Frailty Clinical Trial

— EPAD-C2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574309
• Other study ID #: 21CH030
• Secondary ID: ANSM
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Thomas CELARIER, PhD
• Phone: (0)477821273
• Email: thomas.celarier[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Dissociative Disorders
• Fall Patients
• Frailty

Intervention

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

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	assessment of patients' frailty status	Patients' frailty status will be assessed using the Fried score	at the inclusion
Secondary	assessment of patients' frailty status	Patients' frailty status will be assessed using the Fried score	During walking test
Secondary	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
Secondary	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