Verticalization Robotic Exoskeleton DoC

Overview

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).

Full Title of Study: “Verticalization With Vestibular Stimulation for Patients With Severe Disorders of Consciousness: A Novel Application of a Robotic Exoskeleton”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2021

Interventions

  • Other: Robotic Mobility Device (REX)
    • A self supporting robotic mobility device (REX) will be utilized. It is a Class I device, and it is classified as powered exercise equipment meant for anyone that requires use of a wheelchair for mobility who has difficulty with standing and walking. The participant will be supported securely within the device using a pelvic harness, and thigh and calf cuffs. The device will be operated under the supervision of a device trained physical therapist and therapy technician. The participant will be transferred into the device in a seated position. Once aligned properly and strapped in, the participant will be passively moved by the device into standing and walking positions. To provide constant vestibular input, a variety of mobility functions will be performed including standing, sitting, walking, turning, shuffling (side-stepping), and backwards stepping.
  • Other: Tilt Table
    • A tilt table is a table with a footplate that can be tilted at different angles. The participant will lie flat on the table and straps will be placed to stabilize the trunk and lower extremities. The inclination of the tilt table will be adjusted from a horizontal to a vertical position to allow the participant to attain and maintain a standing or partial-standing position. Sessions will be supervised by a physical therapist and therapy technician.

Arms, Groups and Cohorts

  • Active Comparator: Tilt Table
  • Experimental: Robotic Mobility Device (REX)

Clinical Trial Outcome Measures

Primary Measures

  • Coma Recovery Scale-Revised (CRS-R)
    • Time Frame: through study completion; an average of 8 weeks
    • scores range from 0-23; higher scores mean a better outcome

Secondary Measures

  • Modified Ashworth Scale (MAS)
    • Time Frame: through study completion; an average of 8 weeks
    • scores range from 0-4; lower scores mean a better outcome

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Hermann Health System
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.