The Austrian Spinal Cord Injury Study (ASCIS)

August 27, 2018 updated by: Thomas Freude, Prof. M.D., Paracelsus Medical University

The Austrian Spinal Cord Injury Study (ASCIS)

Traumatic spinal cord injury (tSCI) is a debilitating disease that leads to neurological deficits and often has long-term effects including severe lifelong disability. Given the devastating personal and economic consequences of SCI, it is critical to collect high-quality, prospective data. SCI has not been systemically assessed in Austria, and data regarding the etiology, incidence and prevalence are missing or significantly limited. More importantly to the individuals suffering from SCI, health care for SCI patients in Austria is not concentrated in specialized SCI centers but fragmented, which might result in a less effective recovery and rehabilitation of patients. Accordingly, the Paracelsus Medical University Salzburg (PMU) and the Austrian Social Insurance for Occupational Risks (AUVA) initiated the Austrian Spinal Cord Injury Study (ASCIS) at the beginning of 2012. ASCIS is defined as an organized network that uses observational methods to collect uniform longitudinal clinical data that can provide insight into current patient care parameters and evaluates the outcome of SCI patients. ASCIS was initiated with the aim to develop a registry for patients with tSCI in Austria as a base for addressing research questions, improving patient outcomes and establishing a platform for future clinical trials. Furthermore, a major goal of ASCIS is to get knowledge about the natural recovery after spinal cord lesion in a larger population of patients in the sense of a historical control group and bring new standardized assessment tools to the clinical setting. Due to the involvement of acute trauma hospitals and rehabilitation centers, ASCIS is uniquely positioned to capture detailed hospital-related information on the (very)-acute, rehabilitation and chronic phases of tSCI patients. Additionally, ASCIS is cooperation partner of the European Multi-Center Study about Spinal Cord Injury (EMSCI).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Amstetten, Austria
      • Eisenstadt, Austria
      • Feldkirch, Austria
        • Recruiting
        • Academic Hospital Feldkirch, Department for Trauma Surgery and Sports Traumatology
        • Contact:
        • Contact:
      • Graz, Austria
      • Graz, Austria
      • Horn, Austria
      • Klagenfurt, Austria
      • Klagenfurt, Austria
      • Linz, Austria
      • Linz, Austria
        • Recruiting
        • University Clinic Linz, Department of Neurosurgery, Kepler University Linz
        • Contact:
      • Linz, Austria
        • Recruiting
        • University Clinic Linz, Department of Orthopaedics and Traumatology, Kepler University Linz
        • Contact:
      • Salzburg, Austria
        • Recruiting
        • Trauma Center Salzburg, Teaching Hospital of the Paracelsus Medical University Salzburg
        • Contact:
      • Salzburg, Austria
        • Recruiting
        • University Clinic Salzburg, Department of Orthopaedics and Traumatology, Paracelsus Medical University
        • Contact:
          • Thomas Freude, Prof. M.D.
          • Phone Number: 00435 7255-50001
          • Email: t.freude@salk.at
      • St. Pölten, Austria
      • Vienna, Austria
        • Recruiting
        • Lorenz Böhler Trauma Center Vienna
        • Contact:
      • Vienna, Austria
      • Vienna, Austria
        • Recruiting
        • University Clinic Vienna, Department of Trauma Surgery, Medical University of Vienna
        • Contact:
      • Wiener Neustadt, Austria

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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary Care Centers

Description

Inclusion Criteria:

  • Patients suffering from paresis or plegia after trauma
  • First ASCIS assessment possible within the first 3 days after incidence
  • Patient capable and willing of giving written informed consent
  • No cognitive impairment which would preclude an informed consent (including severe traumatic brain injury)

Exclusion Criteria:

  • Nontraumatic paresis or plegia (e.g. disc-herniation, tumor, AV-malformation, myelitis)
  • Previously known dementia or severe reduction of intelligence, leading to reduced capabilities of cooperation or giving consent
  • Peripheral nerve lesion above the level of lesion (e.g. Plexus brachialis impairment)
  • Previously known polyneuropathy
  • Severe craniocerebral injury

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in American Spinal Injury Association Impairment Scale (AIS)
Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in American Spinal Injury Association Motor Score (ASIAMS)
Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Change in American Spinal Injury Association Sensory Score (ASIASS)
Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Change in Spinal Cord Independency Measure (SCIM)
Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Change in Walking Index for Spinal Cord Injury (WISCI II)
Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Change in Timed Up and Go Test (TuG)
Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Change in 6 Minute Walking Test (6MWT)
Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Change in 10 Meter Timed Walk (10MTW)
Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Change in quality of life using the Short Form 36 (SF-36) questionnaire
Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury

Collaborators and Investigators

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

Sponsor

Paracelsus Medical University

Investigators

  • Study Chair: Herbert Resch, Prof. M.D., Paracelsus Medical University
  • Principal Investigator: Thomas Freude, Prof. M.D., University Clinic Salzburg, Department of Traumatology and Orthopaedics
  • Study Director: Wolfgang Schaden, M.D. Dir., Austrian Social Insurance for Occupational Risks (AUVA)

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.

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)

December 1, 2012

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 31, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ascis1411

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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