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Understanding the Measurement of Girdle Dissociation in the Fall of the Older People Subject. (EPAD-C2)

Primary Purpose

Fall Patients, Frailty

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer
GAITRite Device
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fall Patients focused on measuring fall prevention, older, inertial sensors, dissociation of girdles

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CHU de Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Other

Arm Label

Fallers

non fallers

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

assessment of patients' frailty status
Patients' frailty status will be assessed using the Fried score
assessment of patients' frailty status
Patients' frailty status will be assessed using the Fried score
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).
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).

Full Information

First Posted
October 3, 2022
Last Updated
April 12, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT05574309
Brief Title
Understanding the Measurement of Girdle Dissociation in the Fall of the Older People Subject.
Acronym
EPAD-C2
Official Title
Understanding the Measurement of Girdle Dissociation in the Fall of the Older People Subject. Case-control Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fall Patients, Frailty
Keywords
fall prevention, older, inertial sensors, dissociation of girdles

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fallers
Arm Type
Sham Comparator
Arm Description
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)
Arm Title
non fallers
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer
Intervention Description
Dissociation measure of pelvic and scapular girdles by 2 inertial sensors of accelerometer type (IMU BNO055) during a 10 m walking test
Intervention Type
Device
Intervention Name(s)
GAITRite Device
Intervention Description
Walking parameter measured during a 10 m walking test with GaitRite device
Primary Outcome Measure Information:
Title
measure of position of the pelvic and scapular girdles
Description
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).
Time Frame
During walking test
Secondary Outcome Measure Information:
Title
assessment of patients' frailty status
Description
Patients' frailty status will be assessed using the Fried score
Time Frame
at the inclusion
Title
assessment of patients' frailty status
Description
Patients' frailty status will be assessed using the Fried score
Time Frame
During walking test
Title
Composite outcome : measurement of various walking quantitative parameters
Description
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).
Time Frame
at the inclusion
Title
Composite outcome : measurement of various walking quantitative parameters
Description
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).
Time Frame
During walking test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas CELARIER, PhD
Phone
(0)477821273
Ext
+33
Email
thomas.celarier@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Florence RANCON, CRA
Phone
(0)477829458
Ext
+33
Email
florence.rancon@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas CELARIER, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric CHOL, MD
First Name & Middle Initial & Last Name & Degree
Ludovic LAFAIE, MD
First Name & Middle Initial & Last Name & Degree
Thomas CELARIER, MD PhD
First Name & Middle Initial & Last Name & Degree
Anne-Françoise CHANELIERE, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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