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

August 8, 2019 updated by: Mi Jung Kim, Hanyang University Seoul Hospital

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

This study evaluates the feasibility and effects of H-MEX powered exoskeleton in individuals with paraplegia as a result of spinal cord injury.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: H-MEX
10 participants with paraplegia will participate in explorative gait training using H-MEX powered exoskeleton.
Device: Gait training using H-MEX exoskeleton
Participants will train 3 times a week for 10 weeks using H-MEX powered exoskeleton.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dropout rate
Time Frame: 0-14 weeks
Percentage of participants who drop out before the end of the training period.
0-14 weeks
Number of adverse events
Time Frame: 0-14 weeks
Types and number of the adverse events both serious and non-serious events during training sessions.
0-14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in 6 minute walking test with H-mex exoskeleton
Time Frame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Distance walked over a span of 6 minutes will be examined.
Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Changes in timed up and go test with H-mex exoskeleton
Time Frame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Time that a participants takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured.
Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Changes in Berg balance test with H-mex exoskeleton
Time Frame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Balance will be evaluated by using Berg balance test which is 14-item test designed to assess balance (score range: 0-56, higher values represent a better outcome).
Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Changes in body composition
Time Frame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Body composition will be assessed by using bioelectric impedence analysis.
Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Changes in oxygen uptake during gait training with H-mex exoskeleton
Time Frame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Average and peak oxygen uptake will be measured with participants during gait training.
Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Changes in heart rate during gait training with H-mex exoskeleton
Time Frame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Average and peak heart rate will be measured with participants during gait training.
Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Changes in bone mineral density
Time Frame: Initial evaluation and Final evaluation (after 10 weeks of training)
Bone mineral density will be measured at hip and spine by dual energy X-ray absorptiometry.
Initial evaluation and Final evaluation (after 10 weeks of training)
Changes in colonic transit time
Time Frame: Initial evaluation and Final evaluation (after 10 weeks of training)
Colonic mobility will be assessed by colonic transit time.
Initial evaluation and Final evaluation (after 10 weeks of training)
Changes in quality of life: Short-Form 36-Item Health Survey version 2
Time Frame: Initial evaluation and Final evaluation (after 10 weeks of training)
Quality of life will be assessed by Short-Form 36-Item Health Survey version 2 (total score range: 0-100, higher values represent a better outcome).
Initial evaluation and Final evaluation (after 10 weeks of training)
Changes in fear for fall
Time Frame: Initial evaluation and Final evaluation (after 10 weeks of training)
Fear for fall will be assessed by fall efficacy scale which is 16-item test (score range: 16-64, higher values represent a worse outcome).
Initial evaluation and Final evaluation (after 10 weeks of training)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University Seoul Hospital

Collaborators

Hyundai Motor Company

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

June 19, 2019

First Submitted That Met QC Criteria

August 8, 2019

First Posted (Actual)

August 14, 2019

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hanyang University Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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