Early Rehabilitation of Patients With Posttraumatic Amnesia

Amnesia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00476528
• Other study ID #: NK8633
• Status: Active, not recruiting
• Phase: N/A
• First received: May 21, 2007
• Last updated: August 9, 2010
• Start date: September 2007
• Est. completion date: September 2010

Study information

• Verified date: August 2010
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: September 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Amnesia

Intervention

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.
• Reality Orientation
A quasiexperimental study

Locations

Country	Name	City	State
Denmark	University Hospital	Aarhus	Region Midtjylland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of posttraumatic amnesia Results of score with RLAS, GOAT, GOSE and LOS		12month	No