Verticalization Robotic Exoskeleton DoC

Status unconfirmed · Not applicable

Conditions studied: Brain Injuries, Disorder of Consciousness

In brief

Mobilization, specifically verticalization, has been shown to play a role in enhancing consciousness. Vestibular stimulation has the potential to influence the neural substrate of consciousness, but this modality has not been thoroughly explored. The primary aim of this study is to compare the influence of verticalization with and without vestibular input on level of consciousness in patients experiencing disorders of consciousness (DoC).

Key facts

Study ID

NCT04833543

Run by

Memorial Hermann Health System

People needed

10

Starts

2021-04-21

Expected to finish

2021-12-01

Last updated by the study team

2021-09-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• unresponsive wakefulness syndrome/vegetative state (UWS/VS) or minimally conscious state (MCS) following traumatic brain injury (TBI), intracerebral bleeding, ischemic infarction, or hypoxic brain injury
• Medical clearance by a physician
• 18-75 years old
• Mobilization into standing for at least 10 minutes without signs of orthostasis

You may not qualify if…

• Time since injury less than 4 weeks or more than 6 months
• Mobilization into standing lasts more than 30 minutes
• Severe osteoporosis
• Muscle tone that prevents joint motion (Modified Ashworth Scale (MAS) 4)
• Unstable fractures
• Decubiti on areas contacted by robotic mobility device (i.e. heels, tibia, greater trochanter, ischial tuberosity, sacrum)
• Inability to fit device requirements*
• Height 4'8"-6'4", Weight 88-222 lbs., Hip Flexion 0-90˚, Knee Flexion 0-90˚, Plantigrade

Where it is running

• TIRR Memorial Hermann — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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