Finnish Spinal Cord Injury Study (FinSCI)

Sponsor
The Finnish Association of People with Physical Disabilities (Other)
Overall Status
Completed
CT.gov ID
NCT04649814
Collaborator
Helsinki University Central Hospital (Other), Tampere University Hospital (Other), Oulu University Hospital (Other), The Finnish Association of Spinal Cord Injured Akson (Other), Finnish Institute for Health and Welfare (Other)
1,773
1
10.4
170.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Detailed Description

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

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
1773 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Finnish Spinal Cord Injury Study (FinSCI)
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Dec 15, 2019
Actual Study Completion Date :
Dec 15, 2019

Outcome Measures

Primary Outcome Measures

  1. Cohort Survey of Health, Functioning, and accessibility of spinal cord injury population in Finland [1.2.-31.7.2019]

    Survey includes parameters of secondary conditions of spinal cord injury, independency, environmental factors, health, well-being and services

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Finnish Association of People with Physical Disabilities Helsinki Uusimaa Finland 00280

Sponsors and Collaborators

  • The Finnish Association of People with Physical Disabilities
  • Helsinki University Central Hospital
  • Tampere University Hospital
  • Oulu University Hospital
  • The Finnish Association of Spinal Cord Injured Akson
  • Finnish Institute for Health and Welfare

Investigators

  • Study Director: Hiekkala, PhD, Research Director

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
The Finnish Association of People with Physical Disabilities
ClinicalTrials.gov Identifier:
NCT04649814
Other Study ID Numbers:
  • 42106
First Posted:
Dec 2, 2020
Last Update Posted:
Dec 2, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Finnish Association of People with Physical Disabilities
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 2, 2020