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

NCT ID: NCT02700399

Last Updated: 2016-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erigo® First

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

Step frequency on Erigo® = 48

Group Type: OTHER

Erigo® Hocoma

Intervention Type: DEVICE

Robotics assisted tilt table, without functional electrical stimulation

Traditional tilt table from Rehab-Care

Intervention Type: DEVICE

Traditional tilt table

Traditional first

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

Step frequency on Erigo® = 48

Group Type: OTHER

Erigo® Hocoma

Intervention Type: DEVICE

Robotics assisted tilt table, without functional electrical stimulation

Traditional tilt table from Rehab-Care

Intervention Type: DEVICE

Traditional tilt table

Interventions

Erigo® Hocoma

Robotics assisted tilt table, without functional electrical stimulation

Intervention Type: DEVICE

Traditional tilt table from Rehab-Care

Traditional tilt table

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regionshospitalet Hammel Neurocenter

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jørgen F Nielsen, Prof.MD DMSc

Role: STUDY_DIRECTOR

Regionshospitalet Hammel Neurocenter

Locations

Regionshospitalet Hammel Neurocenter

Hammel, , Denmark

Countries

Denmark

Other Identifiers

SSK01

Identifier Type: -

Identifier Source: org_study_id