The Austrian Spinal Cord Injury Study

Study Overview
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Brief Summary
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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).

Official Title
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The Austrian Spinal Cord Injury Study (ASCIS)

Conditions
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Traumatic Spinal Cord Injury

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury, Spine Surgery, Patient Registry, Trauma