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Erigo®Pro Coma Outcome Study - Study on the Effectiveness of a Robotic Tilt Table Device for Recovery of Consciousness

NCT02639481 · Ludwig-Maximilians - University of Munich · Updated 13 Aug 2019

What is being tested
Standard physiotherapy; Erigo®Pro group without FES; Erigo®Pro group with FES
For
Brain Injuries; Disorders of Consciousness
Kind of study
Tests a treatment or device on volunteers. Phase 3.
Who can join
Ages 18 years to 80 years. About 47 people. The full rules are on the registry page.
Where
Germany (2 sites)
When
Starts or started Jan 2016, ends March 2019. Registered 24 Dec 2015.
Results
None posted yet.

In the researchers' words

Patients with acquired brain injury (ABI) often suffer from severe disorders of consciousness (DOC), such as coma, unresponsive wakefulness syndrome (UWS), or minimally conscious state (MCS). This study examines the effect, a novel robotic rehabilitation device (the Erigo®Pro system) has on the recovery of consciousness of DOC patients. The device enables patients to be verticalized very early during acute neurorehabilitation and includes robotic leg movement training as well as functional electrical stimulation (FES) of leg nerves. Patients will be randomly allocated to one of three treatment groups: (i) control group with standard physiotherapy without the device, (ii) device treatment without FES, and (iii) device treatment with FES. Time until recovery of consciousness, rehabilitation outcome, and amount of complications will be the outcome variables.
ClinicalTrials.gov, NCT02639481

Sites

  • Therapiezentrum BurgauBurgau, Bavaria, Germany
  • Department of Neurology, University of MunichMunich, Bavaria, Germany