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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05574309
Acronym
EPAD-C2
Enrollment
112
Registered
2022-10-10
Start date
2023-01-30
Completion date
2025-01-17
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall Patients, Frailty

Keywords

fall prevention, older, inertial sensors, dissociation of girdles

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.

Interventions

DEVICEDissociation 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

DEVICEGAITRite Device

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
measure of position of the pelvic and scapular girdlesDuring walking testThe 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

MeasureTime frameDescription
assessment of patients' frailty statusat the inclusionPatients' frailty status will be assessed using the Fried score
Composite outcome : measurement of various walking quantitative parametersat the inclusionComposite 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026