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| Name | Class |
|---|---|
| Hyundai Motor Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H-MEX | Experimental | 10 participants with paraplegia will participate in explorative gait training using H-MEX powered exoskeleton. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gait training using H-MEX exoskeleton | Device | Participants will train 3 times a week for 10 weeks using H-MEX powered exoskeleton. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dropout rate | Percentage of participants who drop out before the end of the training period. | 0-14 weeks |
| Number of adverse events | Types and number of the adverse events both serious and non-serious events during training sessions. | 0-14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Changes in timed up and go test with H-mex exoskeleton |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mi Jung Kim, MD PhD | Contact | 82-10-2067-9353 | kimmjreh@hanyang.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Mi Jung Kim, MD PhD | Department of Rehabilitation medicine, Hanyang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Hospital | Recruiting | Seoul | 04763 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33783145 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 5, 2021 | |
| Reset | Apr 29, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 5, 2021 | Apr 29, 2021 |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010264 | Paraplegia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Changes in colonic transit time | Colonic mobility will be assessed by colonic transit time. | 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). | 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). | Initial evaluation and Final evaluation (after 10 weeks of training) |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |