NCT02700399

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Brain Injuries
• Hypotension, Orthostatic
• Syncope

Interventions

Type	Name	Description
DEVICE	Erigo® Hocoma	Robotics assisted tilt table, without functional electrical stimulation
DEVICE	Traditional tilt table from Rehab-Care	Traditional tilt table

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-04-01
• Completion: 2016-06-01
• First posted: 2016-03-07
• Last updated: 2016-06-28

Locations

1 site across 1 country: Denmark