Clinical trial NCT07004478: Turkish Adaptation Study of the Generic Functional Index
Official title: Turkish Adaptation, Validity and Reliability Study of the Generic Functional Index
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Musculoskeletal Diseases
Keywords: function
musculoskeletal
reliability
validity
Generic Functional Index
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with musculoskeletal conditions

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

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.

Primary outcomes:
measure: The Turkish Version of Generic Functional Index
timeFrame: T0 and T1 (Baseline and after 1 week after)
measure: Functional Independence Measure
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul Bilgi University
name: Elif Elcin Dereli, Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul Bilgi University
name: Selina Kara, BSc.
role: PRINCIPAL_INVESTIGATOR
References: