Fear of FallingRAAPCNCT07023718
Impact of Pelvic Joint Stiffness on the Fear of Falling in Subjects Aged Over 75 Years
An observational study of Fear of Falling and Pelvic Joint/Ligament Damage, run by Groupe Hospitalier Sud Ile-de-France at 2 sites in France.
Trial summary
The pelvic girdle is the mechanical structure at the center of the balance and walking systems. The lack of amplitude of the joints that compose it could induce a fear of falling, common in the geriatric population and often underdiagnosed with poorly identified risk factors. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fear of Falling, Pelvic Joint/Ligament Damage
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2021to 31 May 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Older adult
Study population: Male and Female Subjects aged over 75 years old being hospitalized or in institution.
Who may be able to join
- Subjects aged over 75 years hospitalized or in institution in the geriatric department of GHSIF (Groupe Hospitalier Sud -Ile-de France)
Who cannot join
- Patients that have undergone a lumbar surgery
- Patients with hospital diagnosed cognitive troubles
Trial locations and contacts
2 sites in 1 country.
France2 sites
EHPAD Brie Comte Robert
Brie-Comte-Robert, Île-de-France Region, 77000
Centre Hospitalier Melun
Melun, Île-de-France Region, 77000
About this study
Official title: Study of a Cohort of 100 Patients on the Impact of Pelvic Joint Stiffness on the Fear of Falling in Subjects Aged Over 75 Years, Hospitalized or in Institution
The pelvic girdle is the mechanical structure at the center of the balance and walking systems. The lack of amplitude of the joints that compose it could induce a fear of falling, common in the geriatric population and often underdiagnosed with poorly identified risk factors. This study seeks to highlight an association between fear of falling and lack of amplitude of the different joints of the pelvic girdle in order to identify predisposed patients and to set up preventive measures and better medical care.
Read the detailed description
The pelvic girdle is the mechanical structure at the center of the balance and walking systems. The lack of amplitude of the joints that compose it could induce a fear of falling, common in the geriatric population and often underdiagnosed with poorly identified risk factors. Fear of falling is defined as the enduring preoccupation with falling, leading the person to avoid activities that they are capable of doing. It modifies its behavior and affects its quality of life, its well-being and increases the risk of developing pathologies linked to the lack of physical activities. Joint stiffness is a major disorder in the elderly linked to bone and joint aging, but also to lack of mobilization. The pelvic girdle is the mechanical structure at the center of the balance and gait systems. The lack of amplitude of the joints that compose it could induce a fear of falling.
This study seeks to highlight whether there is an association between the fear of falling and the lack of amplitude of the different joints of the pelvic girdle.
- Conditions
- Fear of Falling, Pelvic Joint/Ligament Damage
- Keywords
- pelvic joint;, fear of falling, ankylosis
- Medical subject headings
- Ankylosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between fear of falling and articular stiffness
The primary outcome is the association between joint stiffness and fear of falling:
- Fear of falling assessed by FES-I (score).
- Joint mobility assessed by Schober goniometry (degrees).
- Joint mobility assessed by Schober index (centimeters).
Measured: At inclusion
Secondary outcomes (1)
Validity of 3 FES-I categories based on anthropometric measurements
Using the Falls Efficacy Scale - International (FES-I) questionnaire. It is an improved version of the Fall Efficacy Scale (FES) proposed by Tinetti (18). The FES-I was developed by the Prevention of Falls Network Europe (ProFaNE) group. It is available on the ProFaNE website. The scale includes 16 items, each scored from 1 (not at all concerned) to 4 (very concerned), resulting in a total score range from 16 to 64.
FES-I scores are typically categorized as follows:
Low concern: 16-19
Moderate concern: 20-27
High concern: 28-64
Higher scores indicate a worse outcome, reflecting a greater fear of falling and decreased confidence in performing daily activities safely.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Dec 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of FallingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Sud Ile-de-France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sylvie Aufaure, MD, Principal investigator, Groupe Hospitalier Sud Ile-de-France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023718
- Sponsor's protocol ID
- 2021-A01885-36
- Acronym
- RAAPC
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2023
- Last updated
- 17 Jun 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 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Cohort of 100 Patients on the Impact of Pelvic Joint Stiffness on the Fear of Falling in Subjects Aged Over 75 Years, Hospitalized or in Institution
- ClinicalTrials.gov ID
- NCT07023718
- Acronym / sponsor ID
- RAAPC / 2021-A01885-36
- Conditions
- Fear of Falling, Pelvic Joint/Ligament Damage
- Keywords
- pelvic joint;, fear of falling, ankylosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Groupe Hospitalier Sud Ile-de-FranceUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 17 Jun 2025 (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.
The pelvic girdle is the mechanical structure at the center of the balance and walking systems. The lack of amplitude of the joints that compose it could induce a fear of falling, common in the geriatric population and often underdiagnosed with poorly identified risk factors. This study seeks to highlight an association between fear of falling and lack of amplitude of the different joints of the pelvic girdle in order to identify predisposed patients and to set up preventive measures and better medical care.
Detailed description
The pelvic girdle is the mechanical structure at the center of the balance and walking systems. The lack of amplitude of the joints that compose it could induce a fear of falling, common in the geriatric population and often underdiagnosed with poorly identified risk factors. Fear of falling is defined as the enduring preoccupation with falling, leading the person to avoid activities that they are capable of doing. It modifies its behavior and affects its quality of life, its well-being and increases the risk of developing pathologies linked to the lack of physical activities. Joint stiffness is a major disorder in the elderly linked to bone and joint aging, but also to lack of mobilization. The pelvic girdle is the mechanical structure at the center of the balance and gait systems. The lack of amplitude of the joints that compose it could induce a fear of falling.
This study seeks to highlight whether there is an association between the fear of falling and the lack of amplitude of the different joints of the pelvic girdle.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Male and Female Subjects aged over 75 years old being hospitalized or in institution.
Key inclusion criteria (1 listed)
- Subjects aged over 75 years hospitalized or in institution in the geriatric department of GHSIF (Groupe Hospitalier Sud -Ile-de France)
Key exclusion criteria (2 listed)
- Patients that have undergone a lumbar surgery
- Patients with hospital diagnosed cognitive troubles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between fear of falling and articular stiffness
Time frame: At inclusion
The primary outcome is the association between joint stiffness and fear of falling: * Fear of falling assessed by FES-I (score). * Joint mobility assessed by Schober goniometry (degrees). * Joint mobility assessed by Schober index (centimeters).
1 secondary outcome
Validity of 3 FES-I categories based on anthropometric measurements
Time frame: At inclusion
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 17 Jun 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.
sylvie Aufaure, MD principal investigator
Groupe Hospitalier Sud Ile-de-France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fear of Falling and Pelvic Joint/Ligament Damage, run by Groupe Hospitalier Sud Ile-de-France at 2 sites 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 1 inclusion and 2 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 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Association between fear of falling and articular stiffness (time frame: At inclusion). 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 17 Jun 2025.