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Clinical Trials/NCT05574309
NCT05574309CompletedNot Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country112 target enrollmentStarted: January 30, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
112
Locations
1
Primary Endpoint
measure of position of the pelvic and scapular girdles

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
75 Years to — (Older Adult)
Sex
All
Accepts 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).

Arms & Interventions

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)

Intervention: Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer (Device)

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)

Intervention: GAITRite Device (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)

Intervention: Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer (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)

Intervention: GAITRite Device (Device)

Outcomes

Primary Outcomes

measure of position of the pelvic and scapular girdles

Time Frame: 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 Outcomes

  • assessment of patients' frailty status(During walking test)
  • Composite outcome : measurement of various walking quantitative parameters(During walking test)
  • assessment of patients' frailty status(at the inclusion)
  • Composite outcome : measurement of various walking quantitative parameters(at the inclusion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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