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Recruiting NCT07368244

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

Observational Spinal Cord Injuries (SCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries (SCI). Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Item Content Validity Index (I-CVI) [Time frame: 1 month]
  • Scale Content Validity Index (S-CVI/Ave) [Time frame: 1 month]
Secondary outcome measures (1)
  • Qualitative feedback on clarity/comprehensibility [Time frame: 1 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital — Istanbul

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. PMID 34139132
  • 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. PMID 25264112
  • 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. PMID 26122005

Identifiers

NCT: NCT07368244 · SCI NEFI-SF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗