This study evaluates the feasibility and effects of H-MEX powered exoskeleton in individuals with paraplegia as a result of spinal cord injury.
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
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Participants will train 3 times a week for 10 weeks using H-MEX powered exoskeleton.
Hanyang University Hospital
Seoul, South Korea
RECRUITINGDropout rate
Percentage of participants who drop out before the end of the training period.
Time frame: 0-14 weeks
Number of adverse events
Types and number of the adverse events both serious and non-serious events during training sessions.
Time frame: 0-14 weeks
Changes in 6 minute walking test with H-mex exoskeleton
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)
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.
Time frame: 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
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)
Changes in body composition
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)
Changes in oxygen uptake during gait training with H-mex exoskeleton
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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)
Changes in heart rate during gait training with H-mex exoskeleton
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)
Changes in bone mineral density
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)
Changes in colonic transit time
Colonic mobility will be assessed by colonic transit time.
Time frame: Initial evaluation and Final evaluation (after 10 weeks of training)
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).
Time frame: Initial evaluation and Final evaluation (after 10 weeks of training)
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).
Time frame: Initial evaluation and Final evaluation (after 10 weeks of training)