Early Rehabilitation of Patients With Posttraumatic Amnesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00476528
Recruitment Status : Unknown
Verified August 2010 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : May 22, 2007
Last Update Posted : August 10, 2010
Information provided by:
University of Aarhus

Brief Summary:
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 or disease Intervention/treatment
Amnesia Behavioral: Reality Orientation

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2007
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Duration of posttraumatic amnesia Results of score with RLAS, GOAT, GOSE and LOS [ Time Frame: 12month ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00476528

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

Responsible Party: Jens Christian Sorensen, Professor, Aarhus University Hospital Identifier: NCT00476528     History of Changes
Other Study ID Numbers: NK8633
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: August 10, 2010
Last Verified: August 2010

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:
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders