Verticalization Robotic Exoskeleton DoC

Brain Injuries Clinical Trial

Official title:

Verticalization With Vestibular Stimulation for Patients With Severe Disorders of Consciousness: A Novel Application of a Robotic Exoskeleton

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833543
• Other study ID #: HSC-MH-20-0834
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: December 2021

Study information

• Verified date: August 2021
• Source: Memorial Hermann Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Consciousness Disorders
• Disorder of Consciousness

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	TIRR Memorial Hermann	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Hermann Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Modified Ashworth Scale (MAS)	scores range from 0-4; lower scores mean a better outcome	through study completion; an average of 8 weeks