Turkish Adaptation Study of the Generic Functional Index

NCT07004478 | Recruiting

• 1 other identifier: IstanbulBUFC9
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.The Turkish version of the Generic Functional Index will demonstrate high test-retest reliability when administered to individuals with musculoskeletal disorders.
2. 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.

Conditions

Musculoskeletal Diseases

Keywords

function; musculoskeletal; reliability; validity; Generic Functional Index

Outcome Measures

Primary Outcomes (2)

• 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.

  T0 and T1 (Baseline and after 1 week after)

• 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.

  Baseline

Study Arms (1)

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

Translating the Generic Functional Index into Turkish and Related Processes 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.

Participants with musculoskeletal conditions

Validity 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.

Participants with musculoskeletal conditions

Internal consistency and Reliability OTHER

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

Participants with musculoskeletal conditions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with musculoskeletal conditions

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

Istanbul Bilgi University

Istanbul, Beyoglu, 34065, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Reproducibility of Results

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Evaluation Studies as Topic; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Elif Elcin Dereli, Prof.

  Istanbul Bilgi University

  STUDY DIRECTOR

• Selina Kara, BSc.

  Istanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Furkan Cakir, MSc.

CONTACT

2123115432; fztfurkancakir@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 4, 2025
• Study Start: July 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

TU (1)