Reliability and Validity of the Spinal Cord Injury Secondary Conditions Scale

NCT ID: NCT05935943

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 93 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2023-06-16

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.

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).

Conditions

Spinal Cord Injuries; Reliability; Validity

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pınar Akpınar

Assoc Prof MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

FEYZA UNLU OZKAN, Prof

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

ILKNUR AKTAS, Prof

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

ZEYNEP DEMİR, MD

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Locations

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 17591225 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11124735 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15804318 (View on PubMed)

Other Identifiers

FSMEAH-KAEK 2023/22

Identifier Type: -

Identifier Source: org_study_id