Spinal Cord InjuriesFinSCINCT04649814
Finnish Spinal Cord Injury Study (FinSCI)
An observational study of Spinal Cord Injuries and Health, Subjective, run by The Finnish Association of People with Physical Disabilities at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injuries, Health, Subjective
- What is being tested?
- Questionnaire
- How many people
- 1,773 participants
- Where
- 1 siteFinland
- Study dates
- 1 Feb 2019to 15 Dec 2019
- How long will I take part?
- 1 Day
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Innate SCI
- Progressive new non-traumatic SCI
- Neurodegenerative disease
- Multiple sclerosis amyotrophic lateral sclerosisGuillain-Barre syndrome Institutional care
Trial locations and contacts
1 site in 1 country.
Finland1 site
The Finnish Association of People with Physical Disabilities
Helsinki, Uusimaa, 00280
About this study
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.
Read the detailed description
The detailed description of the protocol has been published. Please, see the reference Tallqvist et al.
- Conditions
- Spinal Cord Injuries, Health, Subjective
- Being tested
- Questionnaire
- Keywords
- patient reported outcomes, ICF, Survey, Interview
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called interview
Questionnaire for all, interview for part of the respondents.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1.2.-31.7.2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Feb 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,773 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- The Finnish Association of People with Physical Disabilities
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Tampere University Hospital, Oulu University Hospital, The Finnish Association of Spinal Cord Injured Akson, Finnish Institute for Health and Welfare
- Responsible party
- Sponsor
- Investigators
- Hiekkala, PhD, Study director, Research Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649814
- Sponsor's protocol ID
- 42106
- Acronym
- FinSCI
- Status last verified
- Feb 2024
- First submitted
- 30 Aug 2018
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We share study protocol.
Publications
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.
PubMed 30805657Tallqvist 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.
PubMed 34511604Majamaki 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.
PubMed 34526631Eskola 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.
PubMed 34888701Poutanen 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.
PubMed 34726579
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finnish Spinal Cord Injury Study (FinSCI)
- ClinicalTrials.gov ID
- NCT04649814
- Acronym / sponsor ID
- FinSCI / 42106
- Conditions
- Spinal Cord Injuries, Health, Subjective
- Keywords
- patient reported outcomes, ICF, Survey, Interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,773 participants (actual)
- Lead sponsor
- The Finnish Association of People with Physical DisabilitiesUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Tampere University Hospital, Oulu University Hospital, The Finnish Association of Spinal Cord Injured Akson, Finnish Institute for Health and Welfare
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 2 Dec 2020 (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.
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.
Detailed description
The detailed description of the protocol has been published. Please, see the reference Tallqvist et al.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Innate SCI
- Progressive new non-traumatic SCI
- Neurodegenerative disease
- Multiple sclerosis amyotrophic lateral sclerosisGuillain-Barre syndrome Institutional care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: interviewQuestionnaire for all, interview for part of the respondents. | Other | – |
Primary outcome
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
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 28 Feb 2024.
- Background: PubMed 30805657Tallqvist 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.
- Background: PubMed 34511604Tallqvist 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.
- Background: PubMed 34526631Majamaki 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.
- Background: PubMed 34888701Eskola 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.
- Background: PubMed 34726579Poutanen 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.
- Project webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We share study protocol.
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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.
Hiekkala, PhD study director
Research Director
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 Health, Subjective, run by The Finnish Association of People with Physical Disabilities at 1 site in Finland.
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 5 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 28 Feb 2024. 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 Finland. 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?
Cohort Survey of Health, Functioning, and accessibility of spinal cord injury population in Finland (time frame: 1.2.-31.7.2019). 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 NCT04649814, which also lists 5 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 28 Feb 2024.