Clinical trial NCT00419939: Intensive Rehabilitation of Patients With Severe Traumatic Brain Injury - Development of a Didactic Model
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniocerebral Trauma
Keywords: Severe traumatic brain injury
Intensive neurorehabilitation
"Patient Participation"[Professional-Patient Relations"
Re-learning
Daily life activities
Rehabilitation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Hammel Neurocenter
First posted: 2007-01-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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 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

Primary outcomes:
measure: Improvement of the patients experience of meaningful learning and influence
timeFrame: 4 -8 weeks
Secondary outcomes:
measure: 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
timeFrame: 4 - 8 weeks
Other outcomes:
Locations:
city: Voldbyvej 15
country: Denmark
facility: Regional Hospital Hammel Neurorehabilitation Centre
state: Hammel
Study officials:
affiliation: Regionshospitalet Hammel Neurocenter
name: Karsten Koch-Jensen, Head of c
role: STUDY_DIRECTOR
affiliation: Department of nursing science, Aarhus University
name: Marit Kirkevold, Professor
role: STUDY_CHAIR
affiliation: Regionshospitalet Hammel Neurocenter
name: Lena Aadal, Ph.d stud.
role: PRINCIPAL_INVESTIGATOR
References: