Clinical trial NCT05574309: Understanding the Measurement of Girdle Dissociation in the Fall of the Older People Subject.
Official title: Understanding the Measurement of Girdle Dissociation in the Fall of the Older People Subject. Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Patients
Frailty
Keywords: fall prevention
older
inertial sensors
dissociation of girdles
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 112
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: measure of position of the pelvic and scapular girdles
timeFrame: During walking test
Secondary outcomes:
measure: assessment of patients' frailty status
timeFrame: at the inclusion
measure: assessment of patients' frailty status
timeFrame: During walking test
measure: Composite outcome : measurement of various walking quantitative parameters
timeFrame: at the inclusion
measure: Composite outcome : measurement of various walking quantitative parameters
timeFrame: During walking test
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Thomas CELARIER, PhD
role: PRINCIPAL_INVESTIGATOR
References: