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The Austrian Spinal Cord Injury Study (ASCIS)

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ClinicalTrials.gov Identifier: NCT03109782
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Freude, Prof. M.D., Paracelsus Medical University

March 31, 2017
April 12, 2017
April 17, 2017
December 2012
December 2023   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT03109782 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Austrian Spinal Cord Injury Study
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).
Not Provided
Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
3 Years
Not Provided
Probability Sample
Primary Care Centers
Traumatic Spinal Cord Injury
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Same as current
December 2023
December 2023   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
14 Years and older   (Child, Adult, Older Adult)
No
Contact: Herbert Resch, Prof. M.D. +43 662 2420-80101 herbert.resch@pmu.ac.at
Contact: Wolfgang Schaden, M.D. +43 5 93 93-20170 wolfgang.schaden@auva.at
Austria
 
 
NCT03109782
ascis1411
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Thomas Freude, Prof. M.D., Paracelsus Medical University
Paracelsus Medical University
Not Provided
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)
Paracelsus Medical University
April 2017