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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04055610
• Other study ID #: Hanyang University Hospital
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2019
• Source: Hanyang University Seoul Hospital
• Contact: Mi Jung Kim, MD PhD
• Phone: 82-10-2067-9353
• Email: kimmjreh[@]hanyang.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Paraplegia
• Spinal Cord Injuries

Intervention

Device:
• Gait training using H-MEX exoskeleton
Participants will train 3 times a week for 10 weeks using H-MEX powered exoskeleton.

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Hanyang University Seoul Hospital	Hyundai Motor Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dropout rate	Percentage of participants who drop out before the end of the training period.	0-14 weeks
Primary	Number of adverse events	Types and number of the adverse events both serious and non-serious events during training sessions.	0-14 weeks
Secondary	Changes in 6 minute walking test with H-mex exoskeleton	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)
Secondary	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.	Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Secondary	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).	Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Secondary	Changes in body composition	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)
Secondary	Changes in oxygen uptake during gait training with H-mex exoskeleton	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)
Secondary	Changes in heart rate during gait training with H-mex exoskeleton	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)
Secondary	Changes in bone mineral density	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)
Secondary	Changes in colonic transit time	Colonic mobility will be assessed by colonic transit time.	Initial evaluation and Final evaluation (after 10 weeks of training)
Secondary	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).	Initial evaluation and Final evaluation (after 10 weeks of training)
Secondary	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).	Initial evaluation and Final evaluation (after 10 weeks of training)