Early Mobilisation After Severe Traumatic Brain Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02924649|
Recruitment Status : Active, not recruiting
First Posted : October 5, 2016
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries||Procedure: Early Intensive mobilisation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Early Mobilisation by Head-up Tilt With Stepping Compared With Standard Care After Severe Traumatic Brain Injury - a Randomised Clinical Feasibility Trial|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2020|
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.
- 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
- Coma Recovery Scale - Revised (CRS-R) [ Time Frame: Measured at inclusion, after four weeks, three months and at one year follow-up ]
- 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.
- Functional Independence Measures (FIM) [ Time Frame: Measured at inclusion, after four weeks, three months and at one year follow-up ]
- 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.
- 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
- 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
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
|Study Director:||Kirsten Møller, Professor||Rigshospitalet, Dept. of anaesthesiology, Rigshospitalet|