NCT07368244

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
405

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

January 7, 2026

Last Update Submit

January 18, 2026

Conditions

Spinal Cord Injuries (SCI)

Keywords

InSCINottwil Environmental Factors InventoryNEFITurkishcultural adaptationcontent validity

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 month

Secondary Outcomes (1)

  • Qualitative feedback on clarity/comprehensibility

    1 month

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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: 34139132BACKGROUND

  • 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: 25264112BACKGROUND

  • 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: 26122005BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Belgin Erhan, Prof

CONTACT

+905322678024dr.belginerhan@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 26, 2026

Study Start

January 1, 2026

Primary Completion

February 1, 2026

Study Completion

February 5, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)