Turkish Adaptation Study of the Generic Functional Index

NCT ID: NCT07004478

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-06-01

Brief Summary

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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

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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.

Conditions

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Musculoskeletal Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Translating the Generic Functional Index into Turkish and Related Processes

Intervention Type OTHER

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.

Validity

Intervention Type OTHER

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.

Internal consistency and Reliability

Intervention Type OTHER

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

Interventions

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Translating 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.

Intervention Type OTHER

Validity

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.

Intervention Type OTHER

Internal 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Bilgi University

OTHER

Sponsor Role lead

Responsible Party

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Furkan Çakır

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elif Elcin Dereli, Prof.

Role: STUDY_DIRECTOR

Istanbul Bilgi University

Selina Kara, BSc.

Role: PRINCIPAL_INVESTIGATOR

Istanbul Bilgi University

Locations

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Istanbul Bilgi University

Istanbul, Beyoglu, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Furkan Cakir, MSc.

Role: CONTACT

2123115432 ext. +90

Facility Contacts

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Elif Elcin Dereli, Prof

Role: primary

2123115445 ext. +90

Other Identifiers

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IstanbulBUFC9

Identifier Type: -

Identifier Source: org_study_id

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