Turkish Translation and Content Validity of the Nottwil Environmental Factors Inventory (NEFI) in Persons With Spinal Cord Injury

January 18, 2026 updated by: Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
This observational methodology study will produce a Turkish version of the Nottwil Environmental Factors Inventory (NEFI-TR) within one month using a standardized translation and cultural adaptation process. Content validity will be assessed using an expert panel (and, if applicable, cognitive debriefing with adults with spinal cord injury) to ensure relevance, clarity, and comprehensibility of each item in the Turkish context.

Study Overview

Status

Recruiting

Detailed Description

Translation/adaptation: (1) two independent forward translations into Turkish; (2) reconciliation and harmonization by a multidisciplinary committee; (3) back-translation by independent translators; (4) expert committee review for semantic, idiomatic, experiential, and conceptual equivalence; (5) pre-test/cognitive debriefing (if planned) and final revisions; (6) proofreading and finalization of NEFI-TR and documentation of all decisions.

Study Type

Observational

Enrollment (Estimated)

405

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital
        • Contact:
        • Sub-Investigator:
          • Bilinç Doğruöz Karatekin, Ass. Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults (≥16 years) living in Turkey with a history of spinal cord injury (traumatic or non-traumatic) who can read and understand Turkish and provide informed consent. Participants will be recruited from rehabilitation/SCI outpatient settings and/or patient networks to complete the Turkish NEFI (NEFI-TR) pretest as part of the translation and content validity process. Individuals coded as fully recovered from SCI (i.e., no ongoing SCI-related limitations) will be excluded.

Description

Inclusion Criteria:

  • Adults (>=16 years) with a diagnosis/history of spinal cord injury (traumatic or non-traumatic)
  • Living in Turkey
  • Able to read/understand Turkish and provide informed consent
  • Clinically stable to complete questionnaires

Exclusion Criteria:

  • Fully recovered from SCI / no longer living with SCI-related functional consequences (as defined by your protocol)
  • Severe cognitive/communication limitations preventing valid completion
  • Any condition judged by investigators to preclude participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Item Content Validity Index (I-CVI)
Time Frame: 1 month
Item Content Validity Index (I-CVI) for NEFI-TR, derived from expert ratings of item relevance on a 4-point scale.
1 month
Scale Content Validity Index (S-CVI/Ave)
Time Frame: 1 month
Scale Content Validity Index (S-CVI/Ave) for NEFI-TR, derived from expert ratings of item relevance on a 4-point scale.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative feedback on clarity/comprehensibility
Time Frame: 1 month
Qualitative feedback on clarity/comprehensibility; proportion of items requiring modification; (if cognitive debriefing) participant-rated clarity and acceptability.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 5, 2026

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because this study is limited to questionnaire translation and content validity assessment and will use minimal, non-interventional data. Only aggregate, de-identified results (e.g., item-level content validity indices and summary statistics) will be reported.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injuries (SCI)

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