Spinal Cord InjuriesNCT05935943
Reliability and Validity of the Spinal Cord Injury Secondary Conditions Scale
An observational study of Spinal Cord Injuries and Reliability, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries, Reliability, Validity
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 May 2022to 16 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with SCI for less than 6 months
- Patients with impaired cognitive functions,
- Patients with other neurological diseases,
- Patients with malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul
About this study
Official title: Reliability and Validity of the Spinal Cord Injury Secondary Conditions Scale Among the Turkish Population With Spinal Cord Injury
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.
Read the 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
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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).
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start31 May 2022
- Primary completion30 May 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Akpınar, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- FEYZA UNLU OZKAN, Prof, Study chair, Fatih Sultan Mehmet Training and Research HospitalILKNUR AKTAS, Prof, Study chair, Fatih Sultan Mehmet Training and Research HospitalZEYNEP DEMİR, MD, Study chair, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935943
- Sponsor's protocol ID
- FSMEAH-KAEK 2023/22
- Status last verified
- Jul 2023
- First submitted
- 20 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17591225Beaton 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.
PubMed 11124735Wild 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.
PubMed 15804318
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Spinal Cord Injury Secondary Conditions Scale Among the Turkish Population With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05935943
- Acronym / sponsor ID
- FSMEAH-KAEK 2023/22
- Conditions
- Spinal Cord Injuries, Reliability, Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients with SCI for less than 6 months
- Patients with impaired cognitive functions,
- Patients with other neurological diseases,
- Patients with malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability of the Spinal Cord Injury Secondary Conditions Scale
Time frame: 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.
1 secondary outcome
Validity of the Spinal Cord Injury Secondary Conditions Scale
Time frame: 1year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Background: PubMed 17591225Kalpakjian 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.
- Background: PubMed 11124735Beaton 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.
- Background: PubMed 15804318Wild 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FEYZA UNLU OZKAN, Prof study chair
Fatih Sultan Mehmet Training and Research Hospital
ILKNUR AKTAS, Prof study chair
Fatih Sultan Mehmet Training and Research Hospital
ZEYNEP DEMİR, MD study chair
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Reliability, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of the Spinal Cord Injury Secondary Conditions Scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05935943, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.