The Austrian Spinal Cord Injury Study
- Conditions
- Traumatic Spinal Cord Injury
- Registration Number
- NCT03109782
- Lead Sponsor
- Paracelsus Medical University
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in American Spinal Injury Association Impairment Scale (AIS) 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
Name Time Method Change in 6 Minute Walking Test (6MWT) 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 Motor Score (ASIAMS) 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) 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) 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) 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) 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) 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 Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Trial Locations
- Locations (18)
Academic Hospital Feldkirch, Department for Trauma Surgery and Sports Traumatology
🇦🇹Feldkirch, Austria
Trauma Center Salzburg, Teaching Hospital of the Paracelsus Medical University Salzburg
🇦🇹Salzburg, Austria
University Clinic Salzburg, Department of Orthopaedics and Traumatology, Paracelsus Medical University
🇦🇹Salzburg, Austria
University Clinic Graz, Department of Orthopaedics and Traumatology, Medical University Graz
🇦🇹Graz, Austria
SMZ Ost Donauspital, Department of Traumatology
🇦🇹Vienna, Austria
Hospital Wiener Neustadt, Department of Traumaotlogy
🇦🇹Wiener Neustadt, Austria
Hospital Klagenfurt, Department of Trauma Surgery and Sports Traumatology
🇦🇹Klagenfurt, Austria
Hospital Horn, Department of Traumatology
🇦🇹Horn, Austria
Trauma Center Klagenfurt
🇦🇹Klagenfurt, Austria
University Clinic Linz, Department of Orthopaedics and Traumatology, Kepler University Linz
🇦🇹Linz, Austria
Trauma Center Linz, Teaching Hospital of the Paracelsus Medical University Linz
🇦🇹Linz, Austria
University Clinic Linz, Department of Neurosurgery, Kepler University Linz
🇦🇹Linz, Austria
University Clinic St. Pölten, Department of Orthopaedics and Traumatology
🇦🇹St. Pölten, Austria
University Clinic Vienna, Department of Trauma Surgery, Medical University of Vienna
🇦🇹Vienna, Austria
Ordensklinikum Barmherzige Brüder Eisenstadt, Department of Orthopaedic Surgery
🇦🇹Eisenstadt, Austria
Trauma Center Graz
🇦🇹Graz, Austria
Hospital Amstetten, Department of Traumatology
🇦🇹Amstetten, Austria
Lorenz Böhler Trauma Center Vienna
🇦🇹Vienna, Austria