- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07368244
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
Conditions
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
- Name: Belgin Erhan, Prof
- Phone Number: +905322678024
- Email: dr.belginerhan@gmail.com
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Recruiting
- Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital
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Contact:
- Belgin Erhan, Prof
- Phone Number: +905322678024
- Email: dr.belginerhan@gmail.com
-
Sub-Investigator:
- Bilinç Doğruöz Karatekin, Ass. Prof.
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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.
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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.
Sponsor
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.
General Publications
- Yang Y, Gong Z, Reinhardt JD, Xu G, Xu Z, Li J. Environmental barriers and participation restrictions in community-dwelling individuals with spinal cord injury in Jiangsu and Sichuan Provinces of China: Results from a cross-sectional survey. J Spinal Cord Med. 2023 Mar;46(2):277-290. doi: 10.1080/10790268.2021.1935094. Epub 2021 Jun 17.
- Ballert CS, Post MW, Brinkhof MW, Reinhardt JD; SwiSCI Study Group. Psychometric properties of the Nottwil Environmental Factors Inventory Short Form. Arch Phys Med Rehabil. 2015 Feb;96(2):233-40. doi: 10.1016/j.apmr.2014.09.004. Epub 2014 Sep 28.
- Juvalta S, Post MW, Charlifue S, Noreau L, Whiteneck G, Dumont FS, Reinhardt JD. Development and cognitive testing of the Nottwil Environmental Factors Inventory in Canada, Switzerland and the USA. J Rehabil Med. 2015 Aug 18;47(7):618-25. doi: 10.2340/16501977-1982.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCI NEFI-SF
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.
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