Status:
UNKNOWN
Gait Training for Individuals With Paraplegia Using the H-MEX Exoskeleton
Lead Sponsor:
Hanyang University Seoul Hospital
Collaborating Sponsors:
Hyundai Motor Company
Conditions:
Spinal Cord Injuries
Paraplegia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study evaluates the feasibility and effects of H-MEX powered exoskeleton in individuals with paraplegia as a result of spinal cord injury.
Detailed Description
Participants with paraplegia will attend gait training using H-MEX powered exoskeleton 3 times a week for 10 weeks. The aim of this study is to assess the impact of gait training using H-MEX powered ...
Eligibility Criteria
Inclusion
- Neurologically stable paraplegia due to traumatic or non-traumatic spinal cord injury at least 2 months since injury
- Age more than 18 years
- Body weight less than 110kg, height between 160-180cm
- Sufficient postural stability to perform level transfer
- Sufficient upper extremity strength to use a walker or crutch
Exclusion
- Spinal instability
- Severe joint contracture in lower extremity
- Unhealed fracture in the major weight bearing bone in the lower extremity
- Skin compromise in areas of contact with the device
- Unresolved deep vein thrombosis
- Uncontrolled hypertension or hypotension
- Severe osteoporosis or osteoporotic fracture unable to gait training
- Lower extremity spasticity exceeding 3 out of 4 (Modified Ashworth Scale) in any joint
- Upper extremity functional limitation due to weakness or contracture
- Psychological or cognitive problem that may limit the participants to understand instructions by investigator
- Any other issue that may interfere with the trial
Key Trial Info
Start Date :
August 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04055610
Start Date
August 8 2019
End Date
December 31 2020
Last Update
August 14 2019
Active Locations (1)
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1
Hanyang University Hospital
Seoul, South Korea, 04763