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

Craniocerebral Trauma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419939
• Other study ID #: 2007-RHN-01
• Status: Completed
• Phase: Phase 0
• First received: January 8, 2007
• Last updated: June 20, 2011
• Start date: February 2007
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Craniocerebral Trauma

Locations

Country	Name	City	State
Denmark	Regional Hospital Hammel Neurorehabilitation Centre	Voldbyvej 15	Hammel

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Regionshospitalet Hammel Neurocenter

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of the patients experience of meaningful learning and influence		4 -8 weeks	No
Secondary	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		4 - 8 weeks	No