Verticalization Robotic Exoskeleton DoC

NCT04833543 | Unknown

• 1 other identifier: HSC-MH-20-0834
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Brain Injuries; Disorder of Consciousness

Outcome Measures

Primary Outcomes (1)

• Coma Recovery Scale-Revised (CRS-R)

  scores range from 0-23; higher scores mean a better outcome

  through study completion; an average of 8 weeks

Secondary Outcomes (1)

• Modified Ashworth Scale (MAS)

  through study completion; an average of 8 weeks

Study Arms (2)

Tilt Table

ACTIVE COMPARATOR

Other: Tilt Table

Robotic Mobility Device (REX)

EXPERIMENTAL

Other: Robotic Mobility Device (REX)

Interventions

Robotic Mobility Device (REX) OTHER

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.

Robotic Mobility Device (REX)

Tilt Table OTHER

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.

Tilt Table

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Memorial Hermann Health System: lead

Study Sites (1)

TIRR Memorial Hermann

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Consciousness Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 6, 2021
• Study Start: April 21, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

US (1)