Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2021-04-21
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tilt Table
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.
Robotic Mobility Device (REX)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Memorial Hermann Health System
OTHER
Responsible Party
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Locations
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TIRR Memorial Hermann
Houston, Texas, United States
Countries
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Facility Contacts
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Other Identifiers
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HSC-MH-20-0834
Identifier Type: -
Identifier Source: org_study_id
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