Finished
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.
Sites
- Therapiezentrum BurgauBurgau, Bavaria, Germany
- Department of Neurology, University of MunichMunich, Bavaria, Germany
