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

University of Aarhus13 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain Injuries Hypotension, Orthostatic Syncope

Interventions

Erigo® HocomaDEVICE

Robotics assisted tilt table, without functional electrical stimulation

Traditional tilt table from Rehab-CareDEVICE

Traditional tilt table

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Regionshospitalet Hammel Neurocenter

Hammel, Denmark

Outcomes

Primary Outcomes

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..

Secondary Outcomes

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.

Time frame: Question is asked within 5 minutes after 60 degrees NIBP measurement

Data from ClinicalTrials.gov

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