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NCT Number: NCT07368244

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

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.

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Key information

Conditions

Spinal Cord Injuries (SCI) Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Belgin Erhan, Prof

CONTACT

[email protected]

+905322678024

Bilinç Doğruöz Karatekin, Ass. Prof.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Belgin Erhan, Prof

CONTACT

[email protected]

+905322678024

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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