Randomized Crossover Study of Pulse Pressure on Respectively Tilt Table With Integrated Stepping Function (Erigo®) and Traditional Tilt Table in Adult Patients With Acquired Brain Injury
Sponsor study identifier
interventional
13
1 country
1
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Actual (reported)Study Completion
June 2016
Actual (reported)The purpose of this study is to determine if the pulse pressure changes are different whether patients are training in a traditional tilt table as compared to a robotic assisted tilt table, which induces leg movement.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
February 5, 2016
Actual (reported)March 7, 2016
Actual (reported)April 2016
Actual (reported)June 2016
Actual (reported)Change in Non Invasive Blood Pressure(NIBP)
Measured at: Baseline in supine on tilttable, 60 seconds after 30 degrees rise of tilttable, 60 seconds after 60 degrees tilt is reached. Again 60 seconds after return to 0 degrees tilt with patient still in supine position on tilttable..
Patient reported comfort: The difference in prevalence of both acceptable- and not acceptable patient comfort between the Erigo and the conventional tilt-table.
Question is asked within 5 minutes after 60 degrees NIBP measurement
Erigo® 0 - 60 degrees - Wash out period (min 30 minutes, max 120 minutes) - Traditional Tilt table 0 - 60 degrees Step frequency on Erigo® = 48
Traditional Tilt table 0 - 60 degrees - Wash out period (min 30 minutes, max 120 minutes) - Erigo® 0 - 60 degrees Step frequency on Erigo® = 48
Robotics assisted tilt table, without functional electrical stimulation
Traditional tilt table
Regionshospitalet Hammel Neurocenter
Hammel, 8450, Denmark
Jørgen F Nielsen, Prof.MD DMSc
Regionshospitalet Hammel Neurocenter
13 participants (actual enrollment reported by the registry).
First Submitted
February 5, 2016
First Posted
March 7, 2016
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Autonomous Syncope Onset Prediction and Prevention
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Primary Completion
April 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
June 28, 2016
Record last verified: 2016-06
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Source: ClinicalTrials.gov.
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