Clinical trial NCT04055610: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Paraplegia
Keywords: H-MEX powered exoskeleton
Exoskeleton
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
Collaborators: name: Hyundai Motor Company
First posted: 2019-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Dropout rate
timeFrame: 0-14 weeks
measure: Number of adverse events
timeFrame: 0-14 weeks
Secondary outcomes:
measure: Changes in 6 minute walking test with H-mex exoskeleton
timeFrame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
measure: Changes in timed up and go test with H-mex exoskeleton
timeFrame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
measure: Changes in Berg balance test with H-mex exoskeleton
timeFrame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
measure: Changes in body composition
timeFrame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
measure: Changes in oxygen uptake during gait training with H-mex exoskeleton
timeFrame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
measure: Changes in heart rate during gait training with H-mex exoskeleton
timeFrame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
measure: Changes in bone mineral density
timeFrame: Initial evaluation and Final evaluation (after 10 weeks of training)
measure: Changes in colonic transit time
timeFrame: Initial evaluation and Final evaluation (after 10 weeks of training)
measure: Changes in quality of life: Short-Form 36-Item Health Survey version 2
timeFrame: Initial evaluation and Final evaluation (after 10 weeks of training)
measure: Changes in fear for fall
timeFrame: Initial evaluation and Final evaluation (after 10 weeks of training)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
Study officials:
affiliation: Department of Rehabilitation medicine, Hanyang University Hospital
name: Mi Jung Kim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.