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NCT04649814 Clinical Trial

Finnish Spinal Cord Injury Study (FinSCI)

Spinal Cord Injuries Clinical Trial

— FinSCI  

Official title:
Finnish Spinal Cord Injury Study (FinSCI)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04649814
Other study ID # 42106
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date December 15, 2019

Study information
Verified date February 2024
Source The Finnish Association of People with Physical Disabilities
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of the Finnish Spinal Cord Injury Study (FinSCI) is to identify factors related to the health and functioning of people with spinal cord injury (SCI), their challenges with accessibility and how such factors are interconnected. The International Classification of Functioning, Disability and Health (ICF) is used in the study as a structured framework. The study participants will be recruited from three SCI outpatient clinics, which together are responsible for the life-time care of the SCI population in Finland. Mixed methods are used including a questionnaire and interviews. The survey will be formed from patient-reported instruments; SCI-specified Spinal Cord Injury Secondary Condition Scale, Spinal Cord Independence Measure, Nottwil Environmental Factors Inventory Short Form and selected items of the generic instruments of Patient-Reported Outcomes Measurement Information System and National study of health, well-being and service. The survey covers 51 ICF categories. The study results can help develop care and rehabilitation policies with SCI, the planning of training models and information provided to various parties involved.

Description:

The detailed description of the protocol has been published. Please, see the reference Tallqvist et al.

Recruitment information / eligibility
Status Completed
Enrollment 1773
Est. completion date December 15, 2019
Est. primary completion date December 15, 2019
Accepts healthy volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - 16 years or over - Traumatic or non-traumatic SCI - ASIA-classification A,B,C tai D - Time since onset of SCI over 6 months - Client of HUS, Tays or Oys SCI outpatient clinic Exclusion Criteria: - Innate SCI - Progressive new non-traumatic SCI - Neurodegenerative disease - Multiple sclerosis amyotrophic lateral sclerosisGuillain-Barre syndrome Institutional care

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire
Questionnaire for all, interview for part of the respondents.

Locations
Country Name City State
Finland The Finnish Association of People with Physical Disabilities Helsinki Uusimaa

Sponsors (6)
Lead Sponsor Collaborator
The Finnish Association of People with Physical Disabilities Finnish Institute for Health and Welfare, Helsinki University Central Hospital, Oulu University Hospital, Tampere University Hospital, The Finnish Association of Spinal Cord Injured Akson

Country where clinical trial is conducted

Finland, 

References & Publications (5)

Eskola K, Koskinen E, Anttila H, Tallqvist S, Bergman P, Kallinen M, Hamalainen H, Kauppila AM, Tackman A, Vainionpaa A, Arokoski J, Rajavaara M, Hiekkala S. Health-related factors for work participation in persons with spinal cord injury in Finland. J Rehabil Med. 2022 Feb 3;54:jrm00255. doi: 10.2340/jrm.v53.59. — View Citation

Majamaki K, Tallqvist S, Vainionpaa A, Koskinen E, Kauppila AM, Bergman P, Anttila H, Hamalainen H, Tackman A, Kallinen M, Arokoski J, Hiekkala S. Functional independence in the Finnish spinal cord injury population. Spinal Cord. 2022 Jul;60(7):628-634. doi: 10.1038/s41393-021-00700-x. Epub 2021 Sep 15. — View Citation

Poutanen J, Anttila H, Tallqvist S, Kallinen M, Koskinen E, Hamalainen H, Kauppila AM, Tackman A, Vainionpaa A, Arokoski J, Hiekkala S. Physical health among the Finnish spinal cord injury population according to the Patient Reported Outcome Measurement Information System (PROMIS(R)). J Spinal Cord Med. 2022 Nov;45(6):865-873. doi: 10.1080/10790268.2021.1989184. Epub 2021 Nov 2. — View Citation

Tallqvist S, Anttila H, Kallinen M, Koskinen E, Hamalainen H, Kauppila AM, Tackman A, Vainionpaa A, Arokoski J, Hiekkala S. Health, functioning and accessibility among spinal cord injury population in Finland: Protocol for the FinSCI study. J Rehabil Med. 2019 Apr 1;51(4):273-280. doi: 10.2340/16501977-2539. — View Citation

Tallqvist S, Kauppila AM, Vainionpaa A, Koskinen E, Bergman P, Anttila H, Hamalainen H, Tackman A, Kallinen M, Arokoski J, Hiekkala S. Prevalence of comorbidities and secondary health conditions among the Finnish population with spinal cord injury. Spinal Cord. 2022 Jul;60(7):618-627. doi: 10.1038/s41393-021-00704-7. Epub 2021 Sep 11. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cohort Survey of Health, Functioning, and accessibility of spinal cord injury population in Finland Survey includes parameters of secondary conditions of spinal cord injury, independency, environmental factors, health, well-being and services 1.2.-31.7.2019
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