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Early Rehabilitation of Patients With Posttraumatic Amnesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Aarhus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00476528
First received: May 21, 2007
Last updated: August 9, 2010
Last verified: August 2010
History of Changes
  Purpose

The purpose of this study is to investigate if a systematic intervention with early identifying of patients with posttraumatic amnesia using a reality orientation therapy can reduce the period with posttraumatic amnesia in order to get a better outcome for patients with traumatic brain injury


Condition Intervention
Amnesia
 Behavioral: Reality Orientation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Early Rehabilitation of Patients With Posttraumatic Amnesia. A Clinical Controlled Investigation of the Effect of a Nursing Programme in Patients With Traumatic Brain Injury in the Acute Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Duration of posttraumatic amnesia Results of score with RLAS, GOAT, GOSE and LOS [ Time Frame: 12month ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: September 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Reality Orientation
    Two matched groups of patients diagnosed with TBI are selected from two university hospitals. In addition to conventional treatment, patients in one group are introduced to a reality- orientation programme consisting of systematic orientation, information, and systematic cooperation with the patient´s relatives.Patients in the other group receive conventional treatment only. All patients are tested on a daily basis in accordance with the RLAS and the GOAT test.
    Behavioral: Reality Orientation
    A quasiexperimental study
Detailed Description:
  1. A systematic review with the latest investigation and treatment of patients with posttraumatic amnesia
  2. Investigate the effect of a systematic nursing programme on the length of posttraumatic amnesia
  3. Investigate the effect of a systematic nursing programme after 12 month
  4. Describe perspectives for the future within the early rehabilitation of patients with posttraumatic amnesia
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients should be able to speak and understand danish
  • Patients with traumatic brain injury
  • A verified brain injury at the CT scanning

Exclusion Criteria:

  • Patients with medical illness
  • Patients with other neurological illness
  • Patients with neuroinfections meningitic, encephalitic
  • Patients who does not understand and speaks danish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476528

Locations
Denmark
University Hospital
Aarhus, Region Midtjylland, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Jens Christian Soerensen Department of Neurosurgery NK
  More Information

No publications provided

Responsible Party: Jens Christian Sorensen, Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00476528     History of Changes
Other Study ID Numbers: NK8633
Study First Received: May 21, 2007
Last Updated: August 9, 2010
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Posttraumatic amnesia
Early intervention
A systematic nursing programme in the ICU
Early identification of patients with posttraumatic amnesia

Additional relevant MeSH terms:
Amnesia
Brain Injuries
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013