Musculoskeletal DiseasesNCT07004478
Turkish Adaptation Study of the Generic Functional Index
An observational study of Musculoskeletal Diseases, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Translating the Generic Functional Index into Turkish and Related Processes, Validity and Internal consistency and Reliability
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Jun 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with musculoskeletal conditions
Who may be able to join
- Being 18 years of age or older,
- Turkish literacy,
- Cognitive competence,
- Having a musculoskeletal disorder
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Bilgi University
Istanbul, Beyoglu, 34065
About this study
Official title: Turkish Adaptation, Validity and Reliability Study of the Generic Functional Index
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:
- The Turkish version of the Generic Functional Index will demonstrate high test-retest reliability when administered to individuals with musculoskeletal disorders.
- 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.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Translating the Generic Functional Index into Turkish and Related Processes, Validity, Internal consistency and Reliability
- Keywords
- function, musculoskeletal, reliability, validity, Generic Functional Index
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translating the Generic Functional Index into Turkish and Related ProcessesOther
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.
ValidityOther
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 ReliabilityOther
The internal consistency of the items will be tested with Cronbach alpha. Test-retest reliability will be tested with intraclass correlation coefficient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Translating the Generic Functional Index into Turkish and Related Processes; Other: Validity; Other: Internal consistency and Reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jul 2025
- Primary completion1 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan Çakır, Istanbul Bilgi University
- Investigators
- Elif Elcin Dereli, Prof., Study director, Istanbul Bilgi UniversitySelina Kara, BSc., Principal investigator, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004478
- Sponsor's protocol ID
- IstanbulBUFC9
- Status last verified
- Jun 2026
- First submitted
- 27 May 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Adaptation, Validity and Reliability Study of the Generic Functional Index
- ClinicalTrials.gov ID
- NCT07004478
- Acronym / sponsor ID
- IstanbulBUFC9
- Conditions
- Musculoskeletal Diseases
- Keywords
- function, musculoskeletal, reliability, validity, Generic Functional Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 4 Jun 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 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:
- The Turkish version of the Generic Functional Index will demonstrate high test-retest reliability when administered to individuals with musculoskeletal disorders.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with musculoskeletal conditions | – | Other: Translating the Generic Functional Index into Turkish and Related Processes, Other: Validity, Other: Internal consistency and ReliabilityThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with musculoskeletal conditions
Key inclusion criteria (4 listed)
- Being 18 years of age or older,
- Turkish literacy,
- Cognitive competence,
- Having a musculoskeletal disorder
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Translating the Generic Functional Index into Turkish and Related ProcessesThe 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. | Other | Participants with musculoskeletal conditions |
| ValidityContent 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. | Other | Participants with musculoskeletal conditions |
| Internal consistency and ReliabilityThe internal consistency of the items will be tested with Cronbach alpha. Test-retest reliability will be tested with intraclass correlation coefficient. | Other | Participants with musculoskeletal conditions |
Primary outcome
The Turkish Version of Generic Functional Index
Time frame: T0 and T1 (Baseline and after 1 week after)
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.
Functional Independence Measure
Time frame: Baseline
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.
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 26 Jun 2026.
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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.
Elif Elcin Dereli, Prof. study director
Istanbul Bilgi University
Selina Kara, BSc. principal investigator
Istanbul Bilgi University
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 Musculoskeletal Diseases, run by Istanbul Bilgi 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 4 inclusion and 3 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 26 Jun 2026. 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?
The Turkish Version of Generic Functional Index (time frame: T0 and T1 (Baseline and after 1 week after)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2026.