ROBOticsSpinalCordInjuryEKSO: Outdoor and Indoor Mobility in People With SCI.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Change from Baseline in Gait Spatiotemporal and Kinematic parameters at 6 months.
研究概览
简要总结
The aim of this study will be to evaluate the safety and the efficacy of a new robotic exoskeleton device in subjects with Spinal Cord Injury (SCI) and in subjects with other neurological disease with an impairment of lower limbs.
详细描述
In this study, 30 participants with chronic spinal cord injury will undergo a 8-week training schedule for ambulation with the EKSO™ device.
Ekso™ is a wearable bionic suit which enables individuals with any amount of lower extremity weakness to stand up and walk over ground with a natural, full weight bearing, reciprocal gait. Walking is achieved by the user's weight shifts to activate sensors in the device which initiate steps. Battery-powered motors drive the legs, replacing deficient neuromuscular function.
Ekso provides functional based rehabilitation, over ground gait training, and upright, weight bearing exercise unlike any other. It has been designed for the needs of busy therapists treating a wide range of patients in a single day. The suit is strapped over the users´ clothing with easy adjustments to transition between patients in as little as five minutes.
Before, during and after training sessions the subjects will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chronic motor complete or incomplete cervical and thoracic (C7-T12) spinal cord injury.
- •Skin integrity.
- •Adequate hip, knee and ankle range of motion.
- •Spasticity level of 3 or less (Ashworth scale).
排除标准
- •Cardiological or respiratory comorbidity.
- •Hemodynamic instability.
- •Presence of unhealed fractures.
- •Presence of heterotopic ossification that may impede walking.
- •Presence of osteoporosis.
结局指标
主要结局
Change from Baseline in Gait Spatiotemporal and Kinematic parameters at 6 months.
时间窗: Ekso training at 0 and 8 weeks, and 24-week follow-up.
Change in score between 0 and 24 weeks. 3D Gait Analysis will be collected at baseline (inclusion) (T0) after 30/40 robot session an expected average of 8 weeks (T1) and at the follow-up examination after 6 months from the training conclusion (T2).
次要结局
- Participant Satisfaction Questionnaire.(Ekso training at 0 and 8 weeks, and 24-week follow-up)
- Change in blood pressure and heart rate during the training.(Ekso training at 0 and 8 weeks, and 24-week follow-up.)
- 6 minutes walking test.(Ekso training at 0 and 8 weeks, and 24-week follow-up.)
- Timed Up and Go test.(Ekso training at 0 and 8 weeks, and 24-week follow-up.)