NCT06153732

Brief Summary

This research will be conducted to examine the relationship between the foot postures and fall risks of elderly individuals living in nursing homes, to identify the factors that most affect the risk of falling, and to inform healthcare professionals working on this subject. Factors that may increase the risk of falling will be determined from the biomechanical changes that occur in the foot with age. In addition, the results we obtain will contribute to the database to be created in the future to identify factors affecting the risk of falling.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

January 2, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

November 23, 2023

Last Update Submit

December 4, 2023

Conditions

Keywords

FallsAgedFoot

Outcome Measures

Primary Outcomes (1)

  • Mini Mental State Test

    For Individuals; A questionnaire consisting of 2 questions about recording memory, 1 about attention and calculation, 1 about remembering, 6 questions about language, 10 questions about orientation and a maximum total score of 30 will be applied. From the MMDT scores; 28-30 range; high normal, 24-27 range indicates low cognitive function, and 0-23 range indicates impaired cognitive status.

    Baseline

Secondary Outcomes (1)

  • Eight Step Up and Go Test included in the Senior Fitness Test:

    Baseline

Other Outcomes (2)

  • Stand on One Foot Test:

    Baseline

  • Foot Posture Index

    Baseline

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Zonguldak Center, Çaycuma and Kdz, affiliated to the Zonguldak Provincial Directorate of Family and Social Services, participated in the study. Volunteer elderly individuals living in Ereğli İzmirlioğlu Nursing Homes who meet the inclusion criteria will participate in the study.An application will be made to Zonguldak Provincial Directorate of Family and Social Services to conduct this study and the necessary permissions will be obtained. The work will begin after receiving permission approval from the relevant units.

You may qualify if:

  • years and older
  • Scoring 24 and above from the Mini Mental State Test
  • Completing the 8 step up and go test in the Senior Fitness Test Protocol

You may not qualify if:

  • Those who need the use of auxiliary tools in performing daily life activities,
  • Those who are in the recovery period of an acute disease,
  • Cancer patients known to be life-threatening,
  • Cardiovascular problem (previous congestive heart failure, transient ischemic attacks),
  • Parkinson's disease,
  • Stroke history in the last 6 months
  • Progressive neuromuscular disease,
  • Acute inner ear inflammation and severe hearing loss,
  • Those who have lost their eyesight enough to be unable to read the test protocol and see the movements in the test,
  • Those who have a fall story in the last year,
  • Those who are in a structured exercise program more than three times a week (not physically active),
  • Those with chronic orthopedic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Center, Kdz. Ereğli İzmirlioğlu and Çaycuma Nursing Homes

Zonguldak, Center, Turkey (Türkiye)

RECRUITING

Study Officials

  • Bahar ANAFOROGLU KULUNKOGLU, Assoc. Prof.

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bahar ANAFOROGLU KULUNKOGLU, Assoc. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 1, 2023

Study Start

January 2, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations