Status:
UNKNOWN
Verticalization Robotic Exoskeleton DoC
Lead Sponsor:
Memorial Hermann Health System
Conditions:
Brain Injuries
Disorder of Consciousness
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04833543
Start Date
April 21 2021
End Date
December 1 2021
Last Update
September 1 2021
Active Locations (1)
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1
TIRR Memorial Hermann
Houston, Texas, United States, 77030