Disability PhysicalNCT06858085
The Turkish Version of the Late Life Function and Disability Instrument
An observational study of Disability Physical, run by Okan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 105 years
- Conditions the study is for
- Disability Physical
- What is being tested?
- Turkish Version of the Late Life Function and Disability Instrument
- How many people
- 216 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 19 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 105 years
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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.
Who cannot join
- Having a neurological problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Turkish Version of the Late Life Function and Disability Instrument in Geriatric Individuals With Gonarthrosis: A Validity and Reliability Study
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.
Read the detailed description
Short Physical Performance Battery (SPPB), Timed Up and Go Test (TUG), Functional Independence Measure (FIM), and Barthel Index of Activities of Daily Living (MBI), among others. However, these tests were designed without a clear theoretical or conceptual framework, and their utility and applicability are limited by the physical and cognitive condition of the individuals being assessed. There is a need for practical, adequate, tolerable, and reliable tests that provide consistent results and allow for a comprehensive evaluation of functional status and the effects of treatment.
Considering the existing tests, the Late Life Function and Disability Instrument (LLFDI) was developed by professors in the Department of Physical Therapy at Boston University to assess meaningful changes in both function and disability categories. The LLFDI has been translated into Hebrew, Swedish, French, Korean, Spanish, Canadian Portuguese, and Brazilian Portuguese, with its reliability and validity confirmed. This instrument is widely used in many countries worldwide.
However, there is currently no study on the Turkish version, validity, and reliability of the Late Life Function and Disability Instrument (LLFDI).
The aim of this study is to investigate the validity and reliability of the Turkish version of the Late Life Function and Disability Instrument (LLFDI) and to provide a measurement tool for researchers in this field to be used in the Turkish literature.
- Conditions
- Disability Physical
- Being tested
- Turkish Version of the Late Life Function and Disability Instrument
- Keywords
- disability, validity, reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Version of the Late Life Function and Disability InstrumentOther
The Late Life Function and Disability Instrument (LLFDI) was developed to assess significant changes in functional and disability categories
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start10 Mar 2025
- Primary completion15 Apr 2025
- Study completion19 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Atıcı, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858085
- Sponsor's protocol ID
- 014
- Status last verified
- Apr 2025
- First submitted
- 22 Feb 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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. 2026 May;48(10):3237-3247. doi: 10.1080/09638288.2025.2587063. Epub 2025 Nov 14.
PubMed 41236801
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Turkish Version of the Late Life Function and Disability Instrument in Geriatric Individuals With Gonarthrosis: A Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT06858085
- Acronym / sponsor ID
- 014
- Conditions
- Disability Physical
- Keywords
- disability, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 19 Apr 2025 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Short Physical Performance Battery (SPPB), Timed Up and Go Test (TUG), Functional Independence Measure (FIM), and Barthel Index of Activities of Daily Living (MBI), among others. However, these tests were designed without a clear theoretical or conceptual framework, and their utility and applicability are limited by the physical and cognitive condition of the individuals being assessed. There is a need for practical, adequate, tolerable, and reliable tests that provide consistent results and allow for a comprehensive evaluation of functional status and the effects of treatment.
Considering the existing tests, the Late Life Function and Disability Instrument (LLFDI) was developed by professors in the Department of Physical Therapy at Boston University to assess meaningful changes in both function and disability categories. The LLFDI has been translated into Hebrew, Swedish, French, Korean, Spanish, Canadian Portuguese, and Brazilian Portuguese, with its reliability and validity confirmed. This instrument is widely used in many countries worldwide.
However, there is currently no study on the Turkish version, validity, and reliability of the Late Life Function and Disability Instrument (LLFDI).
The aim of this study is to investigate the validity and reliability of the Turkish version of the Late Life Function and Disability Instrument (LLFDI) and to provide a measurement tool for researchers in this field to be used in the Turkish literature.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Having a neurological problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish Version of the Late Life Function and Disability InstrumentThe Late Life Function and Disability Instrument (LLFDI) was developed to assess significant changes in functional and disability categories | Other | – |
Primary outcome
Patient Assessment Form
Time frame: Baseline
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.
Mini-Mental Test (MMT)
Time frame: Baseline
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.
Late Life Function and Disability Instrument
Time frame: Baseline
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
Barthel Activities of Daily Living Index
Time frame: Baseline
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
Functional Independence Measure
Time frame: Baseline
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
Lequesne Algofunctional Knee Index
Time frame: Baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Derived from this study: PubMed 41236801Hazar 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. 2026 May;48(10):3237-3247. doi: 10.1080/09638288.2025.2587063. Epub 2025 Nov 14.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disability Physical, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Assessment Form (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06858085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.