Reliability and Validity of the Spinal Cord Injury Secondary Conditions Scale

Spinal Cord Injuries Clinical Trial

Official title:

Reliability and Validity of the Spinal Cord Injury Secondary Conditions Scale Among the Turkish Population With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05935943
• Other study ID #: FSMEAH-KAEK 2023/22
• Status: Completed
• Start date: May 31, 2022
• Est. completion date: June 16, 2023

Study information

• Verified date: July 2023
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 16, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Reliability
• Spinal Cord Injuries
• Validity
• Wounds and Injuries

Locations

Country	Name	City	State
Turkey	Fatih Sultan Mehmet Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Validity of the Spinal Cord Injury Secondary Conditions Scale	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).	1year