Verticalization Robotic Exoskeleton DoC

Memorial Hermann Health System

Status: Unknown

Conditions: Brain Injuries; Disorder of Consciousness

Treatments: Other: Tilt Table; Other: Robotic Mobility Device (REX)

Study type: Interventional

Funder types: Other

Identifiers

NCT04833543

HSC-MH-20-0834

Details and patient eligibility

About

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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Medical clearance by a physician
3. 18-75 years old
4. Mobilization into standing for at least 10 minutes without signs of orthostasis

Exclusion criteria

1. Time since injury less than 4 weeks or more than 6 months

2. Mobilization into standing lasts more than 30 minutes

3. Severe osteoporosis

4. Muscle tone that prevents joint motion (Modified Ashworth Scale (MAS) 4)

5. Unstable fractures

6. Decubiti on areas contacted by robotic mobility device (i.e. heels, tibia, greater trochanter, ischial tuberosity, sacrum)

7. Inability to fit device requirements*

   • Height 4'8"-6'4", Weight 88-222 lbs., Hip Flexion 0-90˚, Knee Flexion 0-90˚, Plantigrade

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Tilt Table

Active Comparator group

Treatment:

Other: Tilt Table

Robotic Mobility Device (REX)

Experimental group

Treatment:

Other: Robotic Mobility Device (REX)