CClinicalTrials.gg
CompletedNCT07004478Updated Jun 26, 2026

Turkish Adaptation Study of the Generic Functional Index

An observational study in Musculoskeletal Diseases, sponsored by Istanbul Bilgi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by Istanbul Bilgi University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The Generic Functional Index is a scale developed to assess the general functional status of individuals. This study aims to evaluate the validity and reliability of the Turkish version of the Generic Functional Index. The adaptation process was designed to follow a standardized translation protocol, including forward translation, expert committee review, back-translation, pilot testing, and psychometric analyses. Data will be collected from individuals with musculoskeletal problems. Psychometric testing will include test-retest reliability, internal consistency, and construct validity analyses.

The main hypotheses of this study are as follows:

  1. The Turkish version of the Generic Functional Index will demonstrate high test-retest reliability when administered to individuals with musculoskeletal disorders.
  2. The scores of the Turkish version of the Generic Functional Index will show a significant positive correlation with the scores of the Functional Independence Measure in individuals with musculoskeletal disorders.
Read the detailed description

Functional assessment is a fundamental component in evaluating the impact of health conditions on individuals' daily lives and in guiding rehabilitation strategies. The Generic Functional Index is a multidimensional instrument developed to assess overall functional status by capturing the effects of a person's problem on their daily activities, mobility, pain, and self-care performance. There is currently no validated Turkish version of the Generic Functional Index available for use in musculoskeletal populations.

This study aims to translate and culturally adapt the Generic Functional Index into Turkish and to investigate its psychometric properties in individuals with musculoskeletal disorders. The adaptation will follow an internationally recognized translation methodology, including forward translation, synthesis, back-translation, expert committee review, and pre-testing. Psychometric evaluation will involve data collection from individuals with musculoskeletal conditions, with analyses focusing on internal consistency, test-retest reliability, and construct validity.

Construct validity will be examined by analyzing the relationship between the Turkish Generic Functional Index and the Functional Independence Measure, which is a widely used tool for assessing independence in daily living activities. A strong correlation between these tools will support the convergent validity of the Turkish Generic Functional Index.

This study is significant because a valid and reliable Turkish version of the Generic Functional Index will provide clinicians and researchers with a standardized tool for evaluating functional limitations in Turkish-speaking populations with musculoskeletal disorders. It will also contribute to the international applicability of the Generic Functional Indexby expanding its use to different cultural and linguistic contexts.

02

Conditions studied

  • Musculoskeletal Diseases

Keywords

  • function
  • musculoskeletal
  • reliability
  • validity
  • Generic Functional Index
03

In context

Musculoskeletal Diseases

657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.

This study's enrollment of 200 is above the median of 126 across 201 observational studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

Istanbul Bilgi University is the lead sponsor of 50 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Participants with musculoskeletal conditions

Inclusion criteria

  • Being 18 years of age or older,
  • Turkish literacy,
  • Cognitive competence,
  • Having a musculoskeletal disorder

Exclusion criteria

Exclusion Criteria:

  • Those with acute functional impairment
  • Those with cognitive impairment, or
  • Those with a mental or physical condition that would prevent them from understanding the scale.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • Participants with musculoskeletal conditions

    The sample will include adult individuals presenting with various musculoskeletal disorders, including but not limited to low back pain, osteoarthritis, tendinopathies, or other soft tissue conditions, which may influence their functional status.

    Other: Translating the Generic Functional Index into Turkish and Related Processes · Other: Validity · Other: Internal consistency and Reliability

Interventions

  • OtherTranslating the Generic Functional Index into Turkish and Related Processes

    The translation process will follow a specific protocol in accordance with the guidelines. It will include two independent forward translations and one back-translation, conducted after obtaining written permission from the original authors. Discrepancies between translations will be reviewed by an expert committee to resolve terminological and cultural differences. The process will ensure conceptual and cultural equivalence between the original English version and the Turkish version. The final version of the questionnaire will be adapted to the target population and finalized in consultation with the original authors.

  • OtherValidity

    Content validity will be calculated with the Content Validity Index, which is a result of expert opinions in terms of clarity, difficulty, and suitability of the Turkish version of the Generic Functional Index.

  • OtherInternal consistency and Reliability

    The internal consistency of the items will be tested with Cronbach alpha. Test-retest reliability will be tested with intraclass correlation coefficient.

06

What researchers measure

Primary outcomes

  1. The Turkish Version of Generic Functional Index

    This index is designed for use across a wide range of musculoskeletal and functional conditions and comprises four parts: Part 1 - Global Status: Patients rate their overall post-injury status on a 0-10 scale, multiplied by 10 to yield a percentage (range: 0-100). Part 2 - Duties and Pain: Assesses functional duties and pain level, each on a 0-10 scale converted to percentages (range: 0-100 each). Part 3 - Functional Limitations: A 10-item checklist (mobility, dressing, sleep, etc.), with full or half points; total score (0-10) is multiplied by 10 for a 100-point scale. Part 4 - Patient-Specific Index: Patients rate up to 5 activities on a 0-10 scale (0 = worst, 10 = best); total is doubled to yield a percentage (range: 0-100). Lower scores indicate greater disability; higher scores reflect better function.

    Time frame: T0 and T1 (Baseline and after 1 week after)

  2. Functional Independence Measure

    Functional Independence Measure will be used to examine the construct validity of the Turkish version of the Generic Functional Index. The Functional Independence Measure is a widely accepted and validated tool that assesses functional independence in daily activities through 18 items across motor and cognitive domains, scored on a 7-point scale. Since both instruments aim to evaluate functional status, a significant correlation between Functional Independence Measure and Generic Functional Index scores would support the convergent validity of the Generic Functional Index. Functional Independence Measure's established use in rehabilitation and its robust psychometric properties make it an appropriate reference measure for this validation study. Total Functional Independence Measure scores range from 18 to 126, where lower scores indicate complete dependence and higher scores reflect complete functional independence.

    Time frame: Baseline

07

Study locations

1 site
  • Istanbul Bilgi University
    Istanbul, Beyoglu 34065, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07004478
Lead sponsor
Istanbul Bilgi University
Responsible party
Furkan Çakır (Principal Investigator, Istanbul Bilgi University) — Principal investigator
First posted
Jun 4, 2025
Start date
Jul 1, 2025
Primary completion
May 1, 2026
Completion
Jun 1, 2026
Last update
Jun 26, 2026

Study contacts

Elif Elcin Dereli, Prof.
study director · Istanbul Bilgi University
Selina Kara, BSc.
principal investigator · Istanbul Bilgi University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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