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

Study Overview
=================
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.

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

Conditions
-----------------
Spinal Cord Injuries, Paraplegia

Intervention / Treatment
-----------------
* Device: Gait training using H-MEX exoskeleton


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: H-MEX<br>10 participants with paraplegia will participate in explorative gait training using H-MEX powered exoskeleton. | Device: Gait training using H-MEX exoskeleton<br>* Participants will train 3 times a week for 10 weeks using H-MEX powered exoskeleton.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
H-MEX powered exoskeleton, Exoskeleton