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

January 20, 2025 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Saint-Étienne, France
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Fallers
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)
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
Device: GAITRite Device
Walking parameter measured during a 10 m walking test with GaitRite device
Other: non fallers
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)
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
Device: GAITRite Device
Walking parameter measured during a 10 m walking test with GaitRite device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
During walking test

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
assessment of patients' frailty status
Time Frame: at the inclusion
Patients' frailty status will be assessed using the Fried score
at the inclusion
assessment of patients' frailty status
Time Frame: During walking test
Patients' frailty status will be assessed using the Fried score
During walking test
Composite outcome : measurement of various walking quantitative parameters
Time Frame: at the inclusion
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
Composite outcome : measurement of various walking quantitative parameters
Time Frame: During walking test
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas CELARIER, PhD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21CH030
  • ANSM (Other Identifier: 2024-A02435-42)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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