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

NCT ID: NCT00419939

Last Updated: 2011-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Craniocerebral Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Regionshospitalet Hammel Neurocenter

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hammel Neurocenter

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karsten Koch-Jensen, Head of c

Role: STUDY_DIRECTOR

Regionshospitalet Hammel Neurocenter

Marit Kirkevold, Professor

Role: STUDY_CHAIR

Department of nursing science, Aarhus University

Lena Aadal, Ph.d stud.

Role: PRINCIPAL_INVESTIGATOR

Regionshospitalet Hammel Neurocenter

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Regional Hospital Hammel Neurorehabilitation Centre

Voldbyvej 15, Hammel, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007-RHN-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.