Finnish Spinal Cord Injury Study (FinSCI) (FinSCI)

February 23, 2024 updated by: The Finnish Association of People with Physical Disabilities

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1773

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00280
        • The Finnish Association of People with Physical Disabilities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Acute care, immediate rehabilitation and life-long multi-professional follow-up, care and rehabilitation of SCI have been centralised at 3 university hospitals: Oulu (OYS), Tampere (Tays) and Helsinki (HUS) university hospitals. They serve the whole SCI-population, both previously and newly injured, in their hospital district areas. The study participants were selected by exploring the patient registries in OYS, Tays and HUS. A more systematic data collection of the SCI population started in different outpatient clinics at different times (Tays 5/2011, OYS 1/2012 and in HUS 8/2013). The selection of patients for the study performed from the start of the systematic data collection and lasted in Tays and OYS till the end of 2017, and in HUS - till the end of June 2018.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Finnish Association of People with Physical Disabilities

Collaborators

Helsinki University Central Hospital
Oulu University Hospital
Tampere University Hospital
Finnish Institute for Health and Welfare
The Finnish Association of Spinal Cord Injured Akson

Investigators

  • Study Director: Hiekkala, PhD, Research Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

December 15, 2019

Study Completion (Actual)

December 15, 2019

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We share study protocol.

IPD Sharing Time Frame

The protocol has been published.

IPD Sharing Access Criteria

To be able to log in Internet.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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