NCT05935943

Brief Summary

People living with spinal cord injury (SCI) experience a range of secondary health conditions that impact their quality of lives. The Spinal Cord Injury Secondary Conditions Scale (SCI-SCS) is a 16-item questionnaire that assess secondary health conditions in persons with SCI. The total score of SCI-SCS range from 0 to 48 and is derived by adding the scores for each item. Higher scores indicate greater problems with secondary conditions. The investigators aimed to determine the reliability and cross-cultural validation of the Turkish translation of the SCI-SCS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

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

May 31, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

June 20, 2023

Last Update Submit

July 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reliability of the Spinal Cord Injury Secondary Conditions Scale

    Participants rated the Spinal Cord Injury Secondary Conditions Scale (SCI-SCS) 2-3 day apart, and test-retest agreement was investigated for the reliability.

    1 year

Secondary Outcomes (1)

  • Validity of the Spinal Cord Injury Secondary Conditions Scale

    1year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients between the ages of 18 and 80 years with SCI, American Spinal Injury Association impairment scale grades from A to D and at least 6 months after injury who volunteered to participate in the study were recruited from the inpatient and outpatient rehabilitation unit of an education and research hospital.

You may qualify if:

  • Patients between the ages of 18 and 80 years with SCI, American Spinal Injury Association impairment scale grades from A to D and at least 6 months after injury. Those who volunteered to participate in the study.

You may not qualify if:

  • Patients with SCI for less than 6 months
  • Patients with impaired cognitive functions,
  • Patients with other neurological diseases,
  • Patients with malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Kalpakjian CZ, Scelza WM, Forchheimer MB, Toussaint LL. Preliminary reliability and validity of a Spinal Cord Injury Secondary Conditions Scale. J Spinal Cord Med. 2007;30(2):131-9. doi: 10.1080/10790268.2007.11753924.

    PMID: 17591225BACKGROUND
  • Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

    PMID: 11124735BACKGROUND
  • Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.

    PMID: 15804318BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

  • FEYZA UNLU OZKAN, Prof

    Fatih Sultan Mehmet Training and Research Hospital

    STUDY CHAIR
  • ILKNUR AKTAS, Prof

    Fatih Sultan Mehmet Training and Research Hospital

    STUDY CHAIR
  • ZEYNEP DEMİR, MD

    Fatih Sultan Mehmet Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof MD

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 7, 2023

Study Start

May 31, 2022

Primary Completion

May 30, 2023

Study Completion

June 16, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations