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Clinical Trials/ISRCTN57815281
ISRCTN57815281
Completed
未知

Improving the communication of people with severe Traumatic Brain Injury (TBI): a clinical trial

niversity of Sydney (Australia)0 sites44 target enrollmentMay 10, 2007

Overview

Phase
未知
Intervention
Not specified
Conditions
Traumatic brain injury
Sponsor
niversity of Sydney (Australia)
Enrollment
44
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

  1. 2009 protocol in: https://doi.org/10.1375/brim.10.2.188 (added 23/05/2019) 2. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23803687 (added 23/05/2019)
Registry
who.int
Start Date
May 10, 2007
End Date
December 1, 2009
Last Updated
6 years ago
Study Type
Interventional

Investigators

Sponsor
niversity of Sydney (Australia)

Eligibility Criteria

Inclusion Criteria

  • Participants must:
  • 1\. Have sustained a moderate to severe TBI for at least 9 months, previously defined as a score on the Glasgow Coma Scale (GCS) of 9 \-12 (moderate), 8 or less (severe) and/or a period of Post Traumatic Amnesia (PTA) of 1\-24 hours (moderate) or more than 24 hours (severe). GCS and PTA is routinely assessed at the participating centers and recorded in hospital files
  • 2\. Be observed by ward or community staff to have significant social skills deficits
  • 3\. Be of at least average pre\-morbid intelligence (as assessed on the WAISIII Vocabulary subtest and demographic information)
  • 4\. Have a regular communication partner with whom they interact on a daily basis
  • Family members or care\-givers will be familiar to the person with TBI, have not sustained a brain injury or have a psychiatric history, and interact with the person with TBI on a regular basis.

Exclusion Criteria

  • 1\. Drug and alcohol addiction or active psychosis as defined by their treating doctor
  • 2\. Aphasia (language impairment) as assessed by their speech pathologist
  • 3\. Non\-English speaking background
  • 4\. Severe amnesia, as assessed by Wechsler Memory Scale
  • 5\. Severe dysarthric (motor speech) impairments which make speech unintelligible

Outcomes

Primary Outcomes

Not specified

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