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

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700399
• Other study ID #: SSK01
• Status: Completed
• Phase: N/A
• First received: February 5, 2016
• Last updated: June 27, 2016
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Hypotension
• Hypotension, Orthostatic
• Syncope

Intervention

Device:
• Erigo® Hocoma
Robotics assisted tilt table, without functional electrical stimulation
• Traditional tilt table from Rehab-Care
Traditional tilt table

Locations

Country	Name	City	State
Denmark	Regionshospitalet Hammel Neurocenter	Hammel

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Regionshospitalet Hammel Neurocenter

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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..	No
Secondary	Patient reported comfort: The difference in prevalence of both acceptable- and not acceptable patient comfort between the Erigo and the conventional tilt-table.	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	No