CClinicalTrials.gg
CompletedNCT05574309EPAD-C2Updated Jan 22, 2025

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

An interventional study of Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer and GAITRite Device in Fall Patients and Frailty, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Non-randomized
Ages
75 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fall Patients
  • Frailty

Keywords

  • fall prevention
  • older
  • inertial sensors
  • dissociation of girdles
03

Who can participate

Ages eligible
75 Years and older
Sexes eligible
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

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).
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (actual)

Study arms

  • 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 · Device: 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 · Device: GAITRite Device

Interventions

  • DeviceDissociation 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

  • DeviceGAITRite Device

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

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: During walking test

Secondary outcomes

  1. assessment of patients' frailty status

    Patients' frailty status will be assessed using the Fried score

    Time frame: at the inclusion

  2. assessment of patients' frailty status

    Patients' frailty status will be assessed using the Fried score

    Time frame: During walking test

  3. 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).

    Time frame: at the inclusion

  4. 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).

    Time frame: During walking test

06

Study locations

1 site
  • CHU de Saint-Etienne
    Saint-Étienne, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05574309
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Oct 10, 2022
Start date
Jan 30, 2023
Primary completion
Jan 17, 2024
Completion
Jan 17, 2025
Last update
Jan 22, 2025

Study contacts

Thomas CELARIER, PhD
principal investigator · Centre Hospitalier Universitaire de Saint Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion