NCT05134038

Brief Summary

  1. 1./ evaluation of the fear of falling using an FES-I questionnaire, distribution of subjects according to the score into 3 groups (16-19: little concerned by the fear of falling, 20-27 moderately concerned, 28-64 very concerned by fear of falling)
  2. 2./ evaluation of lumbar articular mobility by the schober index, coxofemoral by hip goniometry in flexion and extension (no evaluation of other amplitudes because lack of abduction / abduction / external and internal rotation of the hip remain functional in walking and the balance)

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

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

October 23, 2021

Last Update Submit

September 10, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Association FES and goniometry

    Highlight a significant positive association between hips' goniometry (angle degree) and FES-I score (continuous scale without unit)

    15 minutes

  • Association FES-I (continuous scale without unit) and Schober index (centimeter)

    Highlight a significant positive association between Shober index and FES-I score

    15 minutes

Interventions

anthropomorphic measurements + FES questionnaire + demographic data and medications

Also known as: FES questionnaire

Eligibility Criteria

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

\> 75 ans, in any geriatric department of the hospital

You may qualify if:

  • over 75 years old,
  • Ability to understand and answer a questionnaire in French
  • Ability to stand up
  • Patient from the Melun hospital (santé pole center + nursing home of the GHSIF)
  • Affiliated with a social security scheme

You may not qualify if:

  • mental disorders,
  • lumbar surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GH Sud Ile-de-France, CH Melun-Sénart

Melun, France, 77000, France

Location

Related Publications (3)

  • Tinetti ME, Powell L. Fear of falling and low self-efficacy: a case of dependence in elderly persons. J Gerontol. 1993 Sep;48 Spec No:35-8. doi: 10.1093/geronj/48.special_issue.35. No abstract available.

    PMID: 8409238BACKGROUND
  • Kendrick D, Kumar A, Carpenter H, Zijlstra GA, Skelton DA, Cook JR, Stevens Z, Belcher CM, Haworth D, Gawler SJ, Gage H, Masud T, Bowling A, Pearl M, Morris RW, Iliffe S, Delbaere K. Exercise for reducing fear of falling in older people living in the community. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD009848. doi: 10.1002/14651858.CD009848.pub2.

    PMID: 25432016BACKGROUND
  • Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.

    PMID: 20061508BACKGROUND

MeSH Terms

Conditions

Joint DiseasesAtrophy

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • SEBASTIEN JOCHMANS, M.D.

    GHSIF MELUN

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Clinical Research Unit

Study Record Dates

First Submitted

October 23, 2021

First Posted

November 24, 2021

Study Start

December 1, 2021

Primary Completion

May 1, 2022

Study Completion

January 1, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations