NCT03452059已完成不适用
Prospective, Multicenter, Self Controlled Evaluation of the Effectiveness and Safety of Lower Limb Exoskeleton Rehabilitation Training Robot
AI-Robotics Technology Co., Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年7月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Walking efficiency
研究概览
简要总结
Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot
详细描述
Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot developed by AI-Robotics Technology Co., Ltd., Beijing for who had lower limb paralysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more than18 but less than 60 years old，less than 80 kilos of weight，Gender is not limited
- •Confirmed by MR/CT，AIS spinal cord injury grade: A-C level (without walking ability)：Damage plane T6-L2
- •The muscle tension of the modified Ashworth grade level is less than or equal to 2
- •The range of passive motion of the hip and knee joint of the patient is approximately normal in the ankle joint Neutral position
- •Upper limb strength and physical strength are sufficient to stabilize the crutches
- •Patients are able to understand and actively participate in the training program, agree and sign the informed consent form
排除标准
- •The range of motion of the joints is severely limited and the walking action is limited
- •Spinal fractures are not completely healed, the clinical situation is unstable; if not fully confirmed,please go department of orthopedics or other clinical departments for diagnosing
- •Skin injury or infection of the lower extremities or the part of wearing robot
- •Unstable angina, severe arrhythmia and other heart diseases
- •Severe chronic obstructive pulmonary disease
- •Unilateral neglect
- •Severe cognitive or visual impairment
- •Other contraindications or complications that may affect walking training
- •Pregnant or lactating women
- •The investigators find that patients with poor compliance, unable to complete the study in accordance with the requirements
研究组 & 干预措施
AiLegs/AiWalker
Experimental
use of lower extremity rehabilitation training robot assisted walking (including AiLegs, AiWalker)
干预措施: AiLegs, AiWalker and HKAFO (Device)
HKAFO/RGO
Active Comparator
use hip and knee ankle foot orthosis (HKAFO) assisted walking
干预措施: AiLegs, AiWalker and HKAFO (Device)
结局指标
主要结局
Walking efficiency
时间窗: 6 minute
6 minute walk distance,measured by meters
次要结局
- Cardiovascular response(during 6 minute walk test and right before the 6MWT)
- efficiency of put on or take off the Ailegs/Aiwalker/HKAFO(immediately before beginning (pre-) and immediately after finishing (post-) each of 6 minute walk test)
- RPE questionaire(after 6 minute walk test)
研究者
研究点 (1)
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