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

Status Completed

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.

Clinical Trial 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 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

• NCT number: NCT02700399
• Study type: Interventional
• Source: University of Aarhus
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Completion date: June 2016