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Verticalization Robotic Exoskeleton DoC

Primary Purpose

Brain Injuries, Disorder of Consciousness

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic Mobility Device (REX)
Tilt Table
Sponsored by
Memorial Hermann Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • TIRR Memorial HermannRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tilt Table

Robotic Mobility Device (REX)

Arm Description

Outcomes

Primary Outcome Measures

Coma Recovery Scale-Revised (CRS-R)
scores range from 0-23; higher scores mean a better outcome

Secondary Outcome Measures

Modified Ashworth Scale (MAS)
scores range from 0-4; lower scores mean a better outcome

Full Information

First Posted
March 23, 2021
Last Updated
August 31, 2021
Sponsor
Memorial Hermann Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04833543
Brief Title
Verticalization Robotic Exoskeleton DoC
Official Title
Verticalization With Vestibular Stimulation for Patients With Severe Disorders of Consciousness: A Novel Application of a Robotic Exoskeleton
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Hermann Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Disorder of Consciousness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tilt Table
Arm Type
Active Comparator
Arm Title
Robotic Mobility Device (REX)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Robotic Mobility Device (REX)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tilt Table
Intervention Description
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.
Primary Outcome Measure Information:
Title
Coma Recovery Scale-Revised (CRS-R)
Description
scores range from 0-23; higher scores mean a better outcome
Time Frame
through study completion; an average of 8 weeks
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale (MAS)
Description
scores range from 0-4; lower scores mean a better outcome
Time Frame
through study completion; an average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Facility Information:
Facility Name
TIRR Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Anderl
Phone
713-797-7370
Email
elizabeth.anderl@memorialhermann.org

12. IPD Sharing Statement

Learn more about this trial

Verticalization Robotic Exoskeleton DoC

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