Intensive Rehabilitation of Patients With Severe Traumati... | NCT00419939

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

NCT00419939

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jun 21, 2011Estimated

Enrollment

11Actual

Phase

Not provided

Conditions

Craniocerebral Trauma

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jan 8, 2007

First Submission Date that Met QC Criteria

Jan 8, 2007

First Posted Date

Jan 9, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2011

Last Update Posted Date

Jun 21, 2011Estimated

Name	Class
Regionshospitalet Hammel Neurocenter	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of the patients experience of meaningful learning and influence		4 -8 weeks

Secondary Outcomes

Measure	Description	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		4 - 8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karsten Koch-Jensen, Head of c	Regionshospitalet Hammel Neurocenter	Study Director
Marit Kirkevold, Professor	Department of nursing science, Aarhus University	Study Chair
Lena Aadal, Ph.d stud.	Regionshospitalet Hammel Neurocenter	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Regional Hospital Hammel Neurorehabilitation Centre		Voldbyvej 15	Hammel	8450	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006259	Craniocerebral Trauma
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D020196	Trauma, Nervous System
D009422	Nervous System Diseases
D014947	Wounds and Injuries
D001930	Brain Injuries

Browse Leaves

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Browse Branches

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