- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00419939
Intensive Rehabilitation of Patients With Severe Traumatic Brain Injury - Development of a Didactic Model
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.
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Hammel
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Voldbyvej 15, Hammel, Denmark, 8450
- Regional Hospital Hammel Neurorehabilitation Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Severe traumatic brain injury (GCS 3-9)
- Older than 18 years
- Post Traumatic Amnesiphase (PTA) at the end, 4 Ranchos Los Amigos (RLAS) score at minimum 4
- Informed consent
Exclusion Criteria:
- Younger than 18 years
- In PTA phase
- RLAS score lower than 4
- No informed consent
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of the patients experience of meaningful learning and influence
Time Frame: 4 -8 weeks
|
4 -8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
4 - 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-RHN-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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