NCT07023718

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2023

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
Last Updated

June 17, 2025

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 12, 2023

Last Update Submit

June 12, 2025

Conditions

Keywords

pelvic joint;fear of fallingankylosis

Outcome Measures

Primary Outcomes (1)

  • 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).

    At inclusion

Secondary Outcomes (1)

  • Validity of 3 FES-I categories based on anthropometric measurements

    At inclusion

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Male and Female Subjects aged over 75 years old being hospitalized or in institution.

You may qualify if:

  • Subjects aged over 75 years hospitalized or in institution in the geriatric department of GHSIF (Groupe Hospitalier Sud -Ile-de France)

You may not qualify if:

  • Patients that have undergone a lumbar surgery
  • Patients with hospital diagnosed cognitive troubles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

EHPAD Brie Comte Robert

Brie-Comte-Robert, Île-de-France Region, 77000, France

Location

Centre Hospitalier Melun

Melun, Île-de-France Region, 77000, France

Location

MeSH Terms

Conditions

Ankylosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • sylvie Aufaure, MD

    Groupe Hospitalier Sud Ile-de-France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2023

First Posted

June 17, 2025

Study Start

December 1, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

June 17, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations