JPRN-UMIN000024805已完成2 期
Randomized controlled trial to prove the improvement efficacy of the walking program using the wearable assistive robot HAL for the patients with hemiparesis due to stroke. - HIT-2016
niversity of Tsukuba Hospital0 个研究点目标入组 54 人开始时间: 2016年11月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.1st Exclusion (1)The patient with subarachnoid hemorrhage. (2)The patient who can walk outdoor independently. (3)The patient who investigator/subinvestigotor recognized the following symptom. 1)The patient who have akinesia, rigidity, and ataxia with high grade. 2)The patient whom rehabilitation cannot be performed to in the training room. 3)The patient who cannot understand the command and have communication. 4)The patient who has muscle spasm, deformity and contracture on the lower extremity with high grade. (4)The patient who caused waling disorder due to the spinal disease, the peripheral nerve disease, muscle disease, and injury except stroke, and has sever sensory disturbance, and severe lower limbs ischemic disease. (5)The patient who has liver damage, renal damage, cardiovascular disease, and respiratory disease with high grade. (6)The patient with the malignant tumor that does not cure radically. (7)The patient who cannot make the electrode adherent to the body surface by skin disease. (8)The patient who needs hospitalization treatment by the bone fracture, contusion, injury, and its complication in 3months before the pre-observation period. (9)The patient who the bleeding tendency and osteoporosis with the problem on the walking practice. (10)The patient who was included to other clinical trials in 3 months before the 1st inclusion, or has the plan to participate with others. (11)The patient who did walking practice using other robot equipment. (12)The patient who MD judged it no good to participate to the clinical trial. 2.2nd Exclusion (1)The patient who cannot do operation of HAL by CVC mode on the hip joint or knee joint at the end of pre-observation period. (2)The patient who MD judged it no good to participate to the clinical trial.
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