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Early Mobilisation After Severe Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT02924649
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
University Hospital Bispebjerg and Frederiksberg
Information provided by (Responsible Party):
Kirsten Moller, Rigshospitalet, Denmark

Brief Summary:
Increasing focus on the negative effects of bed rest have become more apparent in the intensive care unit within the last decade. A few studies have found an association between early rehabilitation starting at the intensive care unit and outcome after discharge from rehabilitation. The early mobilization presents with challenges regarding haemodynamic stability. The aim of this trial is to assess the feasibility before conducting a larger randomised trial that will investigate benefits and harms of an intensive physical rehabilitation intervention focusing on mobilisation to the upright position, starting as early as clinically feasible in the intensive care unit

Condition or disease Intervention/treatment Phase
Brain Injuries Procedure: Early Intensive mobilisation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Mobilisation by Head-up Tilt With Stepping Compared With Standard Care After Severe Traumatic Brain Injury - a Randomised Clinical Feasibility Trial
Study Start Date : January 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Intensive mobilisation
As early as possible the experimental group will receive mobilisation on a tilt table for up to 20 minutes 5 days a week for four weeks using an ERIGO tilt table. If orthostatic hypotension occur the patient is moved to supine until parameters are stable again. Hereafter the mobilisation will continue until the patient has completed 20 minutes of standing exercise.
Procedure: Early Intensive mobilisation
The intervention will be performed using a tilt table with integrated stepping movements of the lower extremity (ERIGO, HOCOMA, Switzerland). The goal of the intervention session is that the patient stands upright for 20 minutes. If orthostatic intolerance or increase in intracranial pressure occurs the session will be paused. When the patient is stable mobilization is continued.

No Intervention: Standard care group
The standard care group will receive daily mobilisation to the seated position.



Primary Outcome Measures :
  1. Feasibility outcome [ Time Frame: Within the first four weeks of the study (during the intervention period) ]

    Successful inclusion of 60% or more of the patients. The intervention will be considered feasible if at least 80% of the intended treatment sessions are applied to at least 70% of the patients.

    Adverse events and reactions (serious and not serious) and suspected unexpected serious adverse reactions



Secondary Outcome Measures :
  1. Coma Recovery Scale - Revised (CRS-R) [ Time Frame: Measured at inclusion, after four weeks, three months and at one year follow-up ]
  2. Early Functional Ability (EFA) [ Time Frame: Measured at inclusion, after four weeks, three months and at one year follow-up ]
    The Early Functional ability scale measures the gap between FIM and the Glasgow Coma Score.

  3. Functional Independence Measures (FIM) [ Time Frame: Measured at inclusion, after four weeks, three months and at one year follow-up ]
  4. Autoregulation of cerebral blood flow [ Time Frame: At baseline, after two weeks and at four weeks ]
    Using Transcranial Doppler and mean arterial pressure two express cerebral autoregulation during mobilisation to standing position. At these points we will measure carbon dioxide partial pressure and heart rate.

  5. Time with post-traumatic amnesia (PTA) [ Time Frame: Duration of posttraumatic amnesia ]
    The neuro psychologists at the departments are assessing this point on a regular basis

  6. Length of stay at the Neurointensive Care Unit and the Rehabilitation department [ Time Frame: Duration of length of stay ]
    Length of stay measured in days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Traumatic brain injury (TBI)
  • Disorders of consciousness (with a tentative diagnosis of the vegetative or minimally conscious state), with a Glasgow Coma Score < 10 during wake-up call.
  • Stable intracranial pressure (ICP < 20 mmHg for 24 hours).
  • Must be able to mobilise beyond 30 degrees elevation

Exclusion Criteria:

  • Unstable fractures contraindicating mobilisation.
  • Known heart disease or liver cirrhosis prior to brain injury.
  • Spinal cord injury.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924649


Contacts
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Contact: Christian G Riberholt, PT 0045 38622476 christian.riberholt@regionh.dk
Contact: Kirsten Møller, Professor 0045 35451616 kirsten.moeller.01@regionh.dk

Locations
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Denmark
Rigshospitalet, Recruiting
Copenhagen, Denmark
Contact: Christian G Riberholt, Phd. student    22648823    christian.riberholt@regionh.dk   
Contact: Kirsten Møller, Professor       kirsten.moeller.01@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
University Hospital Bispebjerg and Frederiksberg
Investigators
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Study Director: Kirsten Møller, Professor Rigshospitalet, Dept. of anaesthesiology, Rigshospitalet

Publications:
Wilson BA DS, Tunnard C, Watson P and Florschutz G. The Effect of Positioning on the Level of Arousal and Awareness in Patients in the Vegetative State or the Minimally Conscious State: A Replication and Extension of a Previous Finding. BRAIN IMPAIRMENT. 2013;14(3):475-9.
Gronwall D, Wrightson P. Duration of post-traumatic amnesia after mild head injury. Journal of Clinical Neuropsychology. 1980;2(1):51-60.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kirsten Moller, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02924649     History of Changes
Other Study ID Numbers: H-16030775
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kirsten Moller, Rigshospitalet, Denmark:
Brain injury
Early mobilisation
Consciousness
Cerebral blood flow
Blood pressure

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System