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Completed

NCT Number: NCT02700399

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regionshospitalet Hammel Neurocenter

Hammel, 8450, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erigo® Hocoma

Device

Robotics assisted tilt table, without functional electrical stimulation

Traditional tilt table from Rehab-Care

Device

Traditional tilt table

Primary outcomes

  1. 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

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

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

    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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Regionshospitalet Hammel Neurocenter

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 7, 2016
Registry last updated
Jun 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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