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Intensive Rehabilitation of Patients With Severe Traumatic Brain Injury - Development of a Didactic Model

This study has been completed.
Sponsor:
Collaborator:
Regionshospitalet Hammel Neurocenter
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00419939
First received: January 8, 2007
Last updated: June 20, 2011
Last verified: June 2011
History of Changes
  Purpose

The aim of the study is to develop a research-based pedagogic model to improve the interaction between the patient`s motivation, influence and learning.The hypothesis is:

A neuro-rehabilitation effort in patients with severe traumatic brain injury based on a didactic model for improvement of motivation, involvement and re-learning of daily life competences will

  • improve the patients experience of meaningful learning and influence
  • provide staff with a tool which contributes to the experience to work in a targeted way concerning motivation, patient influence and re-learning daily life competencies

The aim of the study is to develop a research-based didactic model to improve the interaction between the patient`s motivation, influence and learning.


Condition Phase
Craniocerebral Trauma
 Phase 0

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Improvement of the Interaction Between Motivation, Involvement and Re-learning of Daily Life Competences During the Intensive Neurorehabilitation of Patients With Severe TBI. Development of a Research-based Didactic Model.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Improvement of the patients experience of meaningful learning and influence [ Time Frame: 4 -8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Provide staff with a tool which contributes to the experience to work in a targeted way concerning motivation, patient influence and re-learning daily life competencies [ Time Frame: 4 - 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: February 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
ab 10 patientsr with acquired severe brain injury (GCS 3 - 9), >18 år, PTA phase at the end (GOAT scoring), RLAS score at minimum 4 and informed consent in writing

Detailed Description:

Annually, about 7500 people get a traumatic brain injury (TBI) in Denmark. According to Danish and international experiences 250 of these get severe injuries. About 120 younger people often males need highly specialised neuro-rehabilitation at one of the two regional centres in Denmark. Due to the limited amount of research in this field it cannot be documented but assumed, that the patient's motivation and involvement in planning and implementation of rehabilitation improve subjective and objective outcome. Motivation, involvement and learning in patients with severe traumatic brain injury constitute a major challenge. The cases are individual, but often involve disturbances in language and perception, lack of realization, reduced initiative, tiredness and depression. The focus of this project is the intensive physical and psychosocial rehabilitation viewed as a process of relearning targeted daily life competences using the ICF levels of function, activity and participation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ab 10 patientsr with acquired severe brain injury (GCS 3 - 9), >18 år, PTA phase at the end (GOAT scoring), RLAS score at minimum 4 and informed consent in writing

Criteria

Inclusion Criteria:

  1. Severe traumatic brain injury (GCS 3-9)
  2. Older than 18 years
  3. Post Traumatic Amnesiphase (PTA) at the end, 4 Ranchos Los Amigos (RLAS) score at minimum 4
  4. Informed consent

Exclusion Criteria:

  1. Younger than 18 years
  2. In PTA phase
  3. RLAS score lower than 4
  4. No informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419939

Locations
Denmark
Regional Hospital Hammel Neurorehabilitation Centre
Voldbyvej 15, Hammel, Denmark, 8450
Sponsors and Collaborators
University of Aarhus
Regionshospitalet Hammel Neurocenter
Investigators
Study Director: Karsten Koch-Jensen, Head of c Regionshospitalet Hammel Neurocenter
Study Chair: Marit Kirkevold, Professor Department of nursing science, Aarhus University
Principal Investigator: Lena Aadal, Ph.d stud. Regionshospitalet Hammel Neurocenter
  More Information

No publications provided

Responsible Party: Jørgen Feldbæk Nielsen, Hammel Neurocenter
ClinicalTrials.gov Identifier: NCT00419939     History of Changes
Other Study ID Numbers: 2007-RHN-01
Study First Received: January 8, 2007
Last Updated: June 20, 2011
Health Authority: Denmark: National Board of Health

Keywords provided by University of Aarhus:
Severe traumatic brain injury
Intensive neurorehabilitation
"Patient Participation"[Professional-Patient Relations"
 Re-learning
Daily life activities
Rehabilitation

Additional relevant MeSH terms:
Craniocerebral Trauma
Brain Injuries
Trauma, Nervous System
Nervous System Diseases
 Wounds and Injuries
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013