NCT06858085

Brief Summary

The aim of this study is to investigate the Turkish validity and reliability of the Late Life Function and Disability Instrument (LLFDI) and to provide a measurement tool for researchers who wish to work in this field within the Turkish literature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

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

February 22, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

February 22, 2025

Last Update Submit

April 19, 2025

Conditions

Keywords

disabilityvalidityreliability

Outcome Measures

Primary Outcomes (6)

  • Patient Assessment Form

    The form, prepared by the researcher, consists of 18 questions aimed at obtaining information on the sociodemographic characteristics of patients. Sociodemographic characteristics include address, age, gender, height, body weight, occupation, education level, social security status, marital status, and dominant hand. Additionally, fall history, medical history, family history, and use of assistive devices will be recorded to obtain general health information.

    Baseline

  • Mini-Mental Test (MMT)

    The Mini-Mental Test (MMT) is widely used in clinical practice for detecting cognitive impairments, monitoring the progression of dementia syndromes, and assessing responses to treatment. It is also used in epidemiological studies involving elderly individuals living in the community or in institutions. The test consists of 11 items grouped under five main sections: Orientation Registration memory Attention and calculation Recall Language The total score is 30 points, and it is one of the most commonly used tests for detecting dementia. It was first described by Folstein (1975) and later refined by Molloy et al. (1991). The test has been validated and found to be reliable in the Turkish population. However, since it was initially applicable only to educated elderly individuals, it was revised in 2008 by Keskinoglu et al. to ensure its validity and reliability for both educated and uneducated elderly populations.

    Baseline

  • Late Life Function and Disability Instrument

    The Late Life Function and Disability Instrument (LLFDI) was developed to assess significant changes in functional and disability categories. The function component consists of 32 questions and is evaluated in three domains: Upper extremity function (7 questions: F1, F3, F5, F6, F13, F16, F17) Basic lower extremity function (14 questions: F2, F10, F11, F12, F14, F15, F18, F21, F22, F23, F25, F26, F28, F31) Advanced lower extremity function (11 questions: F4, F7, F8, F9, F19, F20, F24, F27, F29, F30, F32) Each question is scored using a 5-point rating scale. The disability component consists of 16 questions, evaluated in two dimensions: Frequency Limitation Both dimensions use a 5-point rating scale. The total score of the scale is 100, with higher scores indicating better functional status. The scale was originally developed in the United States by Jette et al. in 2002

    Baseline

  • Barthel Activities of Daily Living Index

    The Barthel Index assesses an individual's ability to perform daily activities independently, such as: Eating Using the toilet Bathing Moving indoors and outdoors The total score is 100, and the dependency levels are classified as follows: 0-20 points → Completely dependent 21-61 points → Severely dependent 62-90 points → Moderately dependent 91-99 points → Mildly dependent 100 points → Fully independent The Barthel Index (BI) was developed by Mahoney and Barthel in 1965. The validity and reliability of its Turkish version were studied by Küçükdeveci et al. in 2000

    Baseline

  • Functional Independence Measure

    The Functional Independence Measure (FIM) evaluates an individual's ability to perform daily activities independently in two domains: Motor Cognitive The total score is 126, and each item is rated as follows: 7 points → Fully independent 6 points → Modified independence 5 points → No physical assistance needed, only verbal cues 4 points → Minimal assistance (the patient performs at least 75% of the effort) 3 points → Moderate assistance (50-75% effort by the patient) 2 points → Maximum assistance (25-50% effort by the patient) 1 point → Total assistance The scale was first developed by Karyl et al. in 1993

    Baseline

  • Lequesne Algofunctional Knee Index

    The Lequesne Algofunctional Knee Index is designed to evaluate patients with gonarthrosis and consists of three main components: Pain or discomfort Maximum walking distance Activities of daily living The total score is 24: For the first and second sections, scores range from 0 (no pain or functional limitation) to 8 (severe pain or functional limitation). The maximum walking distance section is scored from 0 (no limitation) to 6 (walking less than 100 m). If the patient uses one cane or crutch, 1 point is added; if they use two canes or crutches, 2 points are added. Higher scores indicate worse health status. This index was developed by Lequesne et al. in 1987

    Baseline

Interventions

The Late Life Function and Disability Instrument (LLFDI) was developed to assess significant changes in functional and disability categories

Eligibility Criteria

Age65 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of individuals aged 65 and older who have been diagnosed with gonarthrosis. Participants must be able to read and write in Turkish, have no neurological problems, and score above 20 points on the Mini-Mental Test. Only volunteers who meet the inclusion criteria will be included in the study

You may qualify if:

  • over 65 years old,
  • being willing and volunteer to participate in the study,
  • having reading and writing skills,
  • being able to read and write in Turkish,
  • having a diagnosis of gonarthrosis, and
  • scoring above 20 points on the Mini-Mental Test.

You may not qualify if:

  • Having a neurological problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Okan University

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (1)

  • Hazar Y, Atici E, Cagliyan Erdogan H, Kardes K. Cultural adaptation and Turkish version of the Late-Life Function and Disability Instrument for individuals with gonarthrosis: a validity and reliability study. Disabil Rehabil. 2025 Nov 14:1-11. doi: 10.1080/09638288.2025.2587063. Online ahead of print.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2025

First Posted

March 5, 2025

Study Start

March 10, 2025

Primary Completion

April 15, 2025

Study Completion

April 19, 2025

Last Updated

April 24, 2025

Record last verified: 2025-04

Locations