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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05134038
Other study ID # 294
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date January 1, 2023

Study information

Verified date March 2023
Source Hopital of Melun
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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. / 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)


Description:

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. / 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)


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 1, 2023
Est. primary completion date May 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - mental disorders, - lumbar surgery

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
anthropomorphic measurements
anthropomorphic measurements + FES questionnaire + demographic data and medications

Locations

Country Name City State
France GH Sud Ile-de-France, CH Melun-Sénart Melun

Sponsors (1)

Lead Sponsor Collaborator
Hopital of Melun

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Association FES and goniometry Highlight a significant positive association between hips' goniometry (angle degree) and FES-I score (continuous scale without unit) 15 minutes
Primary 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
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