Reliability and Validity of the Spinal Cord Injury Secondary Conditions Scale

Sponsor
Fatih Sultan Mehmet Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05935943
Collaborator
(none)
93
1
12.5
7.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    After translation and back translation of the SCI-SCS, 93 patients between the ages of 18 and 78 years with SCI, American Spinal Injury Association impairment scale grades from A to D and at least 6 months after injury were assessed. Participants rated the SCI-SCS 2-3 day apart, and test-retest agreement was investigated. Factor analysis was done and convergent validity was investigated by correlating the SCI-SCS with the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET), Functional Ambulation Categories (FAC), 36-Item Short Form Health Survey (SF-36), and Spinal Cord Independence Measure III (SCIM-III).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    93 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Reliability and Validity of the Spinal Cord Injury Secondary Conditions Scale Among the Turkish Population With Spinal Cord Injury
    Actual Study Start Date :
    May 31, 2022
    Actual Primary Completion Date :
    May 30, 2023
    Actual Study Completion Date :
    Jun 16, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Reliability of the Spinal Cord Injury Secondary Conditions Scale [1 year]

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

    Secondary Outcome Measures

    1. Validity of the Spinal Cord Injury Secondary Conditions Scale [1year]

      Factor analysis was done and convergent validity was investigated by correlating the SCI-SCS with the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET), Functional Ambulation Categories (FAC), 36-Item Short Form Health Survey (SF-36), and Spinal Cord Independence Measure III (SCIM-III).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    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.

    Exclusion Criteria:
    • Patients with SCI for less than 6 months

    • Patients with impaired cognitive functions,

    • Patients with other neurological diseases,

    • Patients with malignancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fatih Sultan Mehmet Training and Research Hospital Istanbul Turkey

    Sponsors and Collaborators

    • Fatih Sultan Mehmet Training and Research Hospital

    Investigators

    • Study Chair: 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Pınar Akpınar, Assoc Prof MD, Fatih Sultan Mehmet Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05935943
    Other Study ID Numbers:
    • FSMEAH-KAEK 2023/22
    First Posted:
    Jul 7, 2023
    Last Update Posted:
    Jul 7, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 7, 2023