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Completed

NCT Number: NCT05574309

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

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.

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Key information

Conditions

Fall Patients Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, France

About this study

The purpose of this study is to validate the device's measurement of belt dissociation in a discriminating manner between fallers and nonfallers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer

Device

Dissociation measure of pelvic and scapular girdles by 2 inertial sensors of accelerometer type (IMU BNO055) during a 10 m walking test

GAITRite Device

Device

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

Primary outcomes

  1. 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

  1. assessment of patients' frailty status

    Time frame: at the inclusion

    Patients' frailty status will be assessed using the Fried score

  2. assessment of patients' frailty status

    Time frame: During walking test

    Patients' frailty status will be assessed using the Fried score

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: EPAD-C2

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 10, 2022
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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