Effects of Gait Training for Individuals With Paraplegia Using H-MEX Exoskeleton: A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of adverse events
研究概览
简要总结
This study evaluates the feasibility and effects of H-MEX powered exoskeleton in individuals with paraplegia as a result of spinal cord injury.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
H-MEX
10 participants with paraplegia will participate in explorative gait training using H-MEX powered exoskeleton.
干预措施: Gait training using H-MEX exoskeleton (Device)
结局指标
主要结局
Number of adverse events
时间窗: 0-14 weeks
Types and number of the adverse events both serious and non-serious events during training sessions.
Dropout rate
时间窗: 0-14 weeks
Percentage of participants who drop out before the end of the training period.
次要结局
- Changes in body composition(Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training))
- Changes in bone mineral density(Initial evaluation and Final evaluation (after 10 weeks of training))
- 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))
- 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))
- 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))
- Changes in colonic transit time(Initial evaluation and Final evaluation (after 10 weeks of training))
- Changes in fear for fall(Initial evaluation and Final evaluation (after 10 weeks of training))
- 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))
- 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))
- Changes in quality of life: Short-Form 36-Item Health Survey version 2(Initial evaluation and Final evaluation (after 10 weeks of training))
研究者
Mi Jung Kim
Professor of Dept. of Rehabilitation Medicine
Hanyang University Seoul Hospital