Gait Training for Individuals With Paraplegia Using the H-MEX Exoskeleton

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Brief Title

Gait Training for Individuals With Paraplegia Using the H-MEX Exoskeleton

Official Title

Effects of Gait Training for Individuals With Paraplegia Using H-MEX Exoskeleton: A Pilot Study

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
      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.
    


Study Type

Interventional


Primary Outcome

Dropout rate

Secondary Outcome

 Changes in 6 minute walking test with H-mex exoskeleton

Condition

Spinal Cord Injuries

Intervention

Gait training using H-MEX exoskeleton

Study Arms / Comparison Groups

 H-MEX
Description:  10 participants with paraplegia will participate in explorative gait training using H-MEX powered exoskeleton.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

August 8, 2019

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  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 Criteria:

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mi Jung Kim, MD PhD, 82-10-2067-9353, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT04055610

Organization ID

Hanyang University Hospital


Responsible Party

Principal Investigator

Study Sponsor

Hanyang University Seoul Hospital

Collaborators

 Hyundai Motor Company

Study Sponsor

Mi Jung Kim, MD PhD, Principal Investigator, Department of Rehabilitation medicine, Hanyang University Hospital


Verification Date

August 2019