Fall PatientsEPAD-C2NCT05574309
Understanding the Measurement of Girdle Dissociation in the Fall of the Older People Subject.
A study testing Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer and GAITRite Device in people with Fall Patients and Frailty, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Fall Patients, Frailty
- What is being tested?
- Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer and GAITRite Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2023to 17 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Fall Patients, Frailty
- Being tested
- Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer, GAITRite Device
- Keywords
- fall prevention, older, inertial sensors, dissociation of girdles
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometerDevice
Dissociation measure of pelvic and scapular girdles by 2 inertial sensors of accelerometer type (IMU BNO055) during a 10 m walking test
GAITRite DeviceDevice
Walking parameter measured during a 10 m walking test with GaitRite device
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer; Device: GAITRite 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) Receives: Device: Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer; Device: GAITRite Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During walking test
Secondary outcomes (4)
assessment of patients' frailty status
Patients' frailty status will be assessed using the Fried score
Measured: at the inclusion
assessment of patients' frailty status
Patients' frailty status will be assessed using the Fried score
Measured: During walking test
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).
Measured: at the inclusion
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).
Measured: During walking test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start30 Jan 2023
- Primary completion17 Jan 2024
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PatientsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas CELARIER, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574309
- Sponsor's protocol ID
- 21CH030
- Other IDs
- ANSM
- Acronym
- EPAD-C2
- Status last verified
- Apr 2024
- First submitted
- 3 Oct 2022
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Measurement of Girdle Dissociation in the Fall of the Older People Subject. Case-control Study
- ClinicalTrials.gov ID
- NCT05574309
- Acronym / sponsor ID
- EPAD-C2 / 21CH030
- Conditions
- Fall Patients, Frailty
- Keywords
- fall prevention, older, inertial sensors, dissociation of girdles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fallers | Sham comparator | Device: Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer, Device: GAITRite Devicepopulation 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) |
| non fallers | Other | Device: Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer, Device: GAITRite Devicepopulation 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) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometerDissociation measure of pelvic and scapular girdles by 2 inertial sensors of accelerometer type (IMU BNO055) during a 10 m walking test | Device | Fallers, non fallers |
| GAITRite DeviceWalking parameter measured during a 10 m walking test with GaitRite device | Device | Fallers, non fallers |
Primary outcome
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).
4 secondary outcomes
assessment of patients' frailty status
Time frame: at the inclusion
assessment of patients' frailty status
Time frame: During walking test
Composite outcome : measurement of various walking quantitative parameters
Time frame: at the inclusion
Composite outcome : measurement of various walking quantitative parameters
Time frame: During walking test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas CELARIER, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dissociation measure of pelvic and scapular girdles by inertial sensors of accelerometer and GAITRite Device in people with Fall Patients and Frailty, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure of position of the pelvic and scapular girdles (time frame: During walking test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.