The Foot Posture and Falling Risk in Older People

Sponsor
Bahar Anaforoglu Külünkoglu (Other)
Overall Status
Recruiting
CT.gov ID
NCT06153732
Collaborator
(none)
126
1
23
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of this study is to examine the relationship between the foot postures of elderly people living in nursing homes and the risk of falling, to determine the factors that affect the risk of falling the most and to inform healthcare professionals working on this issue.

    Individuals aged 65 and over who scored 24 and above from the Mini Mental State Test and completed the 8-step up and go test in the Senior Fitness Test Protocol were classified in three different ways according to their gender, disease and drug use. The disease status will be handled in two ways, namely the direct and indirect disease group associated with falls.

    The cognitive status of the individuals will be evaluated with the Standardized Mini Mental State Test, the balance and fall risks with the Stand Up One Leg Test and the 8 Step Up and Walk Test included in the Senior Fitness Test, the foot postures with the Foot Posture Index.

    Power analysis was conducted to determine the number of participants required for the study. According to the power analysis result; It was found that the minimum number of participants required to be included in the study for one-way analysis of variance with an effect size of 0.3, α= 0.05, and 85% power was 126.

    Ethics committee approval for the study was received on 05.01.2020 with research number 2020-600. Later, the necessary applications were made to carry out this study at Karadeniz Ereğli İzmirlioğlu Nursing Home, which is affiliated with the Zonguldak Provincial Directorate of Family and Social Services.

    However, due to the Covid-19 pandemic that affected the whole world, the permission approval for the study could be obtained on January 21, 2022 for Karadeniz Ereğli İzmirlioğlu Nursing Home. Upon examination, it was understood that the number of people required to be included in the study could not be reached from just one nursing home.

    For this reason, an application was made again to Ankara Yıldırım Beyazıt University Health Sciences Ethics Committee with the request to add new nursing homes to the study.

    In order to conduct the study in Zonguldak Center and Çaycuma Nursing Homes, a new ethics committee permission was obtained by Ankara Yıldırım Beyazıt University Health Sciences Ethics Committee dated 09.06.22 and Decision No. 10/960.

    Later, the necessary applications were made to the Zonguldak Provincial Directorate of Family and Social Services to carry out this study in Zonguldak Center and Çaycuma Nursing Homes.

    Elderly individuals aged 65 and over living in Zonguldak Center, Karadeniz Ereğli İzmirlioğlu and Çaycuma Nursing Home will be included in the study. Permission approval to carry out the study in these centers could be obtained on August 11, 2022.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    126 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Foot Posture and Falling Risk in Older People
    Actual Study Start Date :
    Jan 2, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Mini Mental State Test [Baseline]

      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.

    Secondary Outcome Measures

    1. Eight Step Up and Go Test included in the Senior Fitness Test: [Baseline]

      It is performed at a distance of 2.44 cm, using a chair with a straight back and no armrest with a seat height of 43.18 cm, a meter, a cone, a stopwatch with an accuracy of 1/10 second. When the individual gets up from the chair with the start command while sitting position, the stopwatch is started with the command. The individual is asked to turn around the cue point at a distance of 2.44 cm as quickly as possible, but without running, and reach the chair again.

    Other Outcome Measures

    1. Stand on One Foot Test: [Baseline]

      For balance evaluation, a one-leg standing test will be performed on the right and left sides. The participant is asked to alternately stand on the right and left foot, with the other foot bent at knee level for 30 seconds. After the participant takes the desired position, measurements will be made 3 times, both with eyes open and with eyes closed, for a maximum of 30 seconds, and the average value will be calculated in seconds. The test will be terminated if the participant's upper foot touches the ground, jumps with his foot on the ground, or opens his eyes.

    2. Foot Posture Index [Baseline]

      The test score is calculated by assigning values between -2 and +2 to the 6 criteria on the foot and summing the scores from all criteria. A test score of 0 indicates that the foot is in a neutral position. A positive test score indicates standing pronation. A negative test score indicates standing supination.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 65 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zonguldak Center, Kdz. Ereğli İzmirlioğlu and Çaycuma Nursing Homes Zonguldak Center Turkey

    Sponsors and Collaborators

    • Bahar Anaforoglu Külünkoglu

    Investigators

    • Principal Investigator: Bahar ANAFOROGLU KULUNKOGLU, Assoc. Prof., Ankara Yildirim Beyazıt University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bahar Anaforoglu Külünkoglu, Associate Professor, Ankara Yildirim Beyazıt University
    ClinicalTrials.gov Identifier:
    NCT06153732
    Other Study ID Numbers:
    • AnkaraYBU
    First Posted:
    Dec 1, 2023
    Last Update Posted:
    Dec 1, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bahar Anaforoglu Külünkoglu, Associate Professor, Ankara Yildirim Beyazıt University

    Study Results

    No Results Posted as of Dec 1, 2023