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

University of Aarhus

Status: Completed

Conditions: Brain Injuries; Syncope; Hypotension, Orthostatic

Treatments: Device: Traditional tilt table from Rehab-Care; Device: Erigo® Hocoma

Study type: Interventional

Funder types: Other

Identifiers

NCT02700399

SSK01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Erigo® First

Other group

Description:

Erigo® 0 - 60 degrees - Wash out period (min 30 minutes, max 120 minutes) - Traditional Tilt table 0 - 60 degrees Step frequency on Erigo® = 48

Treatment:

Device: Traditional tilt table from Rehab-Care

Device: Erigo® Hocoma

Traditional first

Other group

Description:

Traditional Tilt table 0 - 60 degrees - Wash out period (min 30 minutes, max 120 minutes) - Erigo® 0 - 60 degrees Step frequency on Erigo® = 48

Treatment:

Device: Traditional tilt table from Rehab-Care

Device: Erigo® Hocoma