Gait Training for Individuals With Paraplegia Using the H-MEX Exoskeleton
NCT ID: NCT04055610
Last Updated: 2019-08-14
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
2019-08-08
2020-12-31
Brief Summary
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Detailed Description
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The aim of this study is to assess the impact of gait training using H-MEX powered exoskeleton on walking ability, gait analysis, medical examination, body composition, functional evaluation, laboratory findings, quality of life, and subjective experience in individuals with paraplegia.
Participants will be evaluated before, during, and after training.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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H-MEX
10 participants with paraplegia will participate in explorative gait training using H-MEX powered exoskeleton.
Gait training using H-MEX exoskeleton
Participants will train 3 times a week for 10 weeks using H-MEX powered exoskeleton.
Interventions
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Gait training using H-MEX exoskeleton
Participants will train 3 times a week for 10 weeks using H-MEX powered exoskeleton.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Hyundai Motor Company
INDUSTRY
Hanyang University Seoul Hospital
OTHER
Responsible Party
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Mi Jung Kim
Professor of Dept. of Rehabilitation Medicine
Principal Investigators
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Mi Jung Kim, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Rehabilitation medicine, Hanyang University Hospital
Locations
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Hanyang University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Kim HS, Park JH, Lee HS, Lee JY, Jung JW, Park SB, Hyun DJ, Park S, Yoon J, Lim H, Choi YY, Kim MJ. Effects of Wearable Powered Exoskeletal Training on Functional Mobility, Physiological Health and Quality of Life in Non-ambulatory Spinal Cord Injury Patients. J Korean Med Sci. 2021 Mar 29;36(12):e80. doi: 10.3346/jkms.2021.36.e80.
Other Identifiers
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Hanyang University Hospital
Identifier Type: -
Identifier Source: org_study_id
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