Verticalization Robotic Exoskeleton DoC

Not Applicable

• Conditions: Brain Injuries; Disorder of Consciousness
• Interventions: Other: Robotic Mobility Device (REX); Other: Tilt Table

• Registration Number: NCT04833543
• Lead Sponsor: Memorial Hermann Health System

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-04-04
• Study First Posted: 2021-04-06
• Study Start: 2021-04-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic Mobility Device (REX)	Robotic Mobility Device (REX)	-
Tilt Table	Tilt Table	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

TIRR Memorial Hermann; 🇺🇸 Houston, Texas, United States