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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tilt Table | Active Comparator |
| |
| Robotic Mobility Device (REX) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Ashworth Scale (MAS) | scores range from 0-4; lower scores mean a better outcome | through study completion; an average of 8 weeks |
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Inclusion Criteria:
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*
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TIRR Memorial Hermann | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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|
| 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. |
|
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |