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

Primary Purpose

Spinal Cord Injuries, Paraplegia

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gait training using H-MEX exoskeleton
Sponsored by
Hanyang University Seoul Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Spinal Cord Injuries focused on measuring H-MEX powered exoskeleton, Exoskeleton

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hanyang University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

H-MEX

Arm Description

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

Outcomes

Primary Outcome Measures

Dropout rate
Percentage of participants who drop out before the end of the training period.
Number of adverse events
Types and number of the adverse events both serious and non-serious events during training sessions.

Secondary Outcome Measures

Changes in 6 minute walking test with H-mex exoskeleton
Distance walked over a span of 6 minutes will be examined.
Changes in timed up and go test with H-mex exoskeleton
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.
Changes in Berg balance test with H-mex exoskeleton
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).
Changes in body composition
Body composition will be assessed by using bioelectric impedence analysis.
Changes in oxygen uptake during gait training with H-mex exoskeleton
Average and peak oxygen uptake will be measured with participants during gait training.
Changes in heart rate during gait training with H-mex exoskeleton
Average and peak heart rate will be measured with participants during gait training.
Changes in bone mineral density
Bone mineral density will be measured at hip and spine by dual energy X-ray absorptiometry.
Changes in colonic transit time
Colonic mobility will be assessed by colonic transit time.
Changes in quality of life: Short-Form 36-Item Health Survey version 2
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).
Changes in fear for fall
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).

Full Information

First Posted
June 19, 2019
Last Updated
August 8, 2019
Sponsor
Hanyang University Seoul Hospital
Collaborators
Hyundai Motor Company
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1. Study Identification

Unique Protocol Identification Number
NCT04055610
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 8, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanyang University Seoul Hospital
Collaborators
Hyundai Motor Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Paraplegia
Keywords
H-MEX powered exoskeleton, Exoskeleton

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
H-MEX
Arm Type
Experimental
Arm Description
10 participants with paraplegia will participate in explorative gait training using H-MEX powered exoskeleton.
Intervention Type
Device
Intervention Name(s)
Gait training using H-MEX exoskeleton
Intervention Description
Participants will train 3 times a week for 10 weeks using H-MEX powered exoskeleton.
Primary Outcome Measure Information:
Title
Dropout rate
Description
Percentage of participants who drop out before the end of the training period.
Time Frame
0-14 weeks
Title
Number of adverse events
Description
Types and number of the adverse events both serious and non-serious events during training sessions.
Time Frame
0-14 weeks
Secondary Outcome Measure Information:
Title
Changes in 6 minute walking test with H-mex exoskeleton
Description
Distance walked over a span of 6 minutes will be examined.
Time Frame
Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Title
Changes in timed up and go test with H-mex exoskeleton
Description
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.
Time Frame
Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Title
Changes in Berg balance test with H-mex exoskeleton
Description
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).
Time Frame
Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Title
Changes in body composition
Description
Body composition will be assessed by using bioelectric impedence analysis.
Time Frame
Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Title
Changes in oxygen uptake during gait training with H-mex exoskeleton
Description
Average and peak oxygen uptake will be measured with participants during gait training.
Time Frame
Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Title
Changes in heart rate during gait training with H-mex exoskeleton
Description
Average and peak heart rate will be measured with participants during gait training.
Time Frame
Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Title
Changes in bone mineral density
Description
Bone mineral density will be measured at hip and spine by dual energy X-ray absorptiometry.
Time Frame
Initial evaluation and Final evaluation (after 10 weeks of training)
Title
Changes in colonic transit time
Description
Colonic mobility will be assessed by colonic transit time.
Time Frame
Initial evaluation and Final evaluation (after 10 weeks of training)
Title
Changes in quality of life: Short-Form 36-Item Health Survey version 2
Description
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).
Time Frame
Initial evaluation and Final evaluation (after 10 weeks of training)
Title
Changes in fear for fall
Description
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).
Time Frame
Initial evaluation and Final evaluation (after 10 weeks of training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mi Jung Kim, MD PhD
Phone
82-10-2067-9353
Email
kimmjreh@hanyang.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mi Jung Kim, MD PhD
Organizational Affiliation
Department of Rehabilitation medicine, Hanyang University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University Hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi Jung Kim, MD PhD
Phone
82-10-2067-9353
Email
kimmjreh@hanyang.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33783145
Citation
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.
Results Reference
derived

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

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