Study of Pulse Pressure During Tilttable and Erigo® in Adult Patients With Acquired Brain Injury

June 27, 2016 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The trial takes place in a non private hospital in Denmark. Patients are recruited from two wards treating patients with severe brain injury, and all patients admitted in the study period are considered in regards to inclusion or exclusion. Patients are included via closest relatives accept, and the patients GP(General Practitioner). Any adverse effect or event will be reported to the local ethics committee. All data will be collected simultaneously with the interventions. Some data will be directly recorded via monitor output, and some data will be directly inputted in Epidata, while trial takes place.

Sample size has been calculated to be between 10 and 60 individuals depending on the actual difference. Beyond 60 included individuals the clinical relevance of a statistical significant result is no longer apparent. If any individual variables are noncomplete, an analysis of the subjects with missing data, will be undertaken.

The statistical analyses planned follows the general crossover design using an approach considering 2 treatment and 2 periods. Patients are cluster randomized in clusters of 4, to be treated with one or the other intervention first.

Intervention A:

Traditional tilt table. measurements at 0 degrees 30 deg. 60. deg. and at return to 0 deg.

Intervention B:

Erigo® tilttable, with measurements as in intervention A. During the intervention the step frequency of the Erigo® i set at 48 steps/min.

Between the two periods a wash out period of at least ½ hour and maximum 2 hours are planned.

Primary outcome is derived from noninvasive BP measurements.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hammel, Denmark, 8450
        • Regionshospitalet Hammel Neurocenter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Already being treated with traditional tilttable and must be able to benefit from Erigo® treatment from a clinicians view
  • Acquired brain injury as primary diagnose
  • Must have Rancho Los Amigo Scale score of minimum 1 to maximum 6 on the day of inclusion

Exclusion Criteria:

  • Not on mechanical ventilation
  • New cerebral, cardiological or other medical problems/emergencies between the 2 interventions
  • Change in cardiac medications between interventions
  • Patient must not have independent gait function immediately before trial
  • must not have EFA(Early Functional abilities) part score > 4 in the section "Standing", assessed by the treating physiotherapist.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Erigo® First

Erigo® 0 - 60 degrees - Wash out period (min 30 minutes, max 120 minutes) - Traditional Tilt table 0 - 60 degrees

Step frequency on Erigo® = 48
Device: Erigo® Hocoma
Robotics assisted tilt table, without functional electrical stimulation
Device: Traditional tilt table from Rehab-Care
Traditional tilt table
Other: Traditional first

Traditional Tilt table 0 - 60 degrees - Wash out period (min 30 minutes, max 120 minutes) - Erigo® 0 - 60 degrees

Step frequency on Erigo® = 48
Device: Erigo® Hocoma
Robotics assisted tilt table, without functional electrical stimulation
Device: Traditional tilt table from Rehab-Care
Traditional tilt table

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Non Invasive Blood Pressure(NIBP)
Time Frame: 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..
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..

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported comfort: The difference in prevalence of both acceptable- and not acceptable patient comfort between the Erigo and the conventional tilt-table.
Time Frame: Question is asked within 5 minutes after 60 degrees NIBP measurement
Due to the included patients level of consciousness, comfort is reported as the treating therapists subjective evaluation of patients answers to standardized visual and audial question.
Question is asked within 5 minutes after 60 degrees NIBP measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Regionshospitalet Hammel Neurocenter

Investigators

  • Study Director: Jørgen F Nielsen, Prof.MD DMSc, Regionshospitalet Hammel Neurocenter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 7, 2016

Study Record Updates

Last Update Posted (Estimate)

June 28, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSK01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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