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

NCT02700399 | Completed DMC

• 1 other identifier: SSK01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries; Hypotension, Orthostatic; Syncope

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Non Invasive Blood Pressure(NIBP)

  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 (1)

• Patient reported comfort: The difference in prevalence of both acceptable- and not acceptable patient comfort between the Erigo and the conventional tilt-table.

  Question is asked within 5 minutes after 60 degrees NIBP measurement

Study Arms (2)

Erigo® First

OTHER

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

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

Traditional first

OTHER

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

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

Interventions

Erigo® Hocoma DEVICE

Robotics assisted tilt table, without functional electrical stimulation

Erigo® First; Traditional first

Traditional tilt table from Rehab-Care DEVICE

Traditional tilt table

Erigo® First; Traditional first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Regionshospitalet Hammel Neurocenter: collaborator

Study Sites (1)

Regionshospitalet Hammel Neurocenter

Hammel, 8450, Denmark

Location

MeSH Terms

Conditions

Brain Injuries; Hypotension, Orthostatic; Syncope

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jørgen F Nielsen, Prof.MD DMSc

  Regionshospitalet Hammel Neurocenter

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: March 7, 2016
• Study Start: July 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 28, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)