Gait Training for Individuals With Paraplegia Using the H-MEX Exoskeleton
- Conditions
- ParaplegiaSpinal Cord Injuries
- Interventions
- Device: Gait training using H-MEX exoskeleton
- Registration Number
- NCT04055610
- Lead Sponsor
- Hanyang University Seoul Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description H-MEX Gait training using H-MEX exoskeleton 10 participants with paraplegia will participate in explorative gait training using H-MEX powered exoskeleton.
- Primary Outcome Measures
Name Time Method Number of adverse events 0-14 weeks Types and number of the adverse events both serious and non-serious events during training sessions.
Dropout rate 0-14 weeks Percentage of participants who drop out before the end of the training period.
- Secondary Outcome Measures
Name Time Method Changes in Berg balance test with H-mex exoskeleton 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).
Changes in oxygen uptake during gait training with H-mex exoskeleton 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.
Changes in heart rate during gait training with H-mex exoskeleton 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.
Changes in body composition 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.
Changes in bone mineral density 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.
Changes in colonic transit time Initial evaluation and Final evaluation (after 10 weeks of training) Colonic mobility will be assessed by colonic transit time.
Changes in fear for fall 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).
Changes in 6 minute walking test with H-mex exoskeleton 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.
Changes in timed up and go test with H-mex exoskeleton 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.
Changes in quality of life: Short-Form 36-Item Health Survey version 2 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).
Trial Locations
- Locations (1)
Hanyang University Hospital
🇰🇷Seoul, Korea, Republic of