Spinal Cord Injuries (SCI)NCT07368244
Turkish Translation and Content Validity of the Nottwil Environmental Factors Inventory (NEFI) in Persons With Spinal Cord Injury
An observational study of Spinal Cord Injuries (SCI), run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- How many people
- 405 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 5 Feb 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital
Istanbul
Belgin Erhan, Prof, +905322678024, dr.belginerhan@gmail.com
Bilinç Doğruöz Karatekin, Ass. Prof.
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- InSCI, Nottwil Environmental Factors Inventory, NEFI, Turkish, cultural adaptation, content validity
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Item Content Validity Index (I-CVI)
Item Content Validity Index (I-CVI) for NEFI-TR, derived from expert ratings of item relevance on a 4-point scale.
Measured: 1 month
Scale Content Validity Index (S-CVI/Ave)
Scale Content Validity Index (S-CVI/Ave) for NEFI-TR, derived from expert ratings of item relevance on a 4-point scale.
Measured: 1 month
Secondary outcomes (1)
Qualitative feedback on clarity/comprehensibility
Qualitative feedback on clarity/comprehensibility; proportion of items requiring modification; (if cognitive debriefing) participant-rated clarity and acceptability.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jan 2026
- Primary completion1 Feb 2026 (estimated)
- Study completion5 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injuries (SCI)Studies 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
- Cross-sectional
- Enrolment
- 405 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368244
- Sponsor's protocol ID
- SCI NEFI-SF
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 34139132Ballert 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.
PubMed 25264112Juvalta 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.
PubMed 26122005
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Translation and Content Validity of the Nottwil Environmental Factors Inventory (NEFI) in Persons With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07368244
- Acronym / sponsor ID
- SCI NEFI-SF
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- InSCI, Nottwil Environmental Factors Inventory, NEFI, Turkish, cultural adaptation, content validity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 5 Feb 2026 (estimated)
- First posted
- 26 Jan 2026 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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 secondary outcome
Qualitative feedback on clarity/comprehensibility
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 34139132Yang 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.
- Background: PubMed 25264112Ballert 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.
- Background: PubMed 26122005Juvalta 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.
- Individual participant dataSharing planned: No. 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.
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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.
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 Spinal Cord Injuries (SCI), run by Istanbul Medeniyet 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: looking for participants now, as of the sponsor's last update on 26 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Belgin Erhan, Prof (+905322678024, dr.belginerhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Item Content Validity Index (I-CVI) (time frame: 1 month). 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?
On the ClinicalTrials.gov record for NCT07368244, which also lists 3 linked publications.
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 Jan 2026.