JPRN-jRCTs032180314已完成未知
The theRapeutic effects of peroneal nerve functionAl electrical stimuLation for Lower extremitY in patients with sub-acute post-stroke hemiplegia (RALLY) A randomized controlled study - RALLY study
Matsumoto Shuji0 个研究点目标入组 203 人开始时间: 2019年3月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 203
研究概览
简要总结
The findings of the current study demonstrated the feasibility of applying WA for dropped foot during the convalescent phase of recovery after stroke.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •1) Patients who agree to participate in this study and provide their informed consent
- •2) Patients from 20 to 85 years old at the time of consent
- •3) Patients of convalescent stoke (within 6 months of onset)
- •4) Patients with a first episode of stroke, which type limited intracranial hemorrhage or ischemic stroke (excluding subarachnoid hemorrhage)
- •5) Patients inpatients for the rehabilitation therapy
- •6) Patients diagnosed 3 or 4 on Functional Ambulation Classification (FAC)
- •7) Patients stable general condition (blood pressure, pulse, blood glucose level etc.)
- •8) Patients with drop foot in walking
排除标准
- •1) Patients due to severe heart disease
- •2) Patients with previous gait disability, such as neurological disease
- •3) Patients with previous orthopedic disease, such as knee osteoarthritis
- •4) Patients with severe hepatic or renal dysfunction
- •5) Patients with severe sensory disturbance or severe ataxia or severe higher brain dysfunction
- •6) Patients correspond to contraindicated for the electrical stimulation (e.g. patients with a medical implant or implantable medical electrical equipment such as a cardiac pacemaker)
- •7) Patients with severe skin disease
- •8) Patients with any dose adjustment of antispasticity drugs (tizanidine hydrochloride, eperisone hydrochloride, baclofen, etc.) within 1month
- •9) Patients whose impairment severities changed during the study period
- •10) Patients taking the botulinum toxin formulation injection or the nerve block injection with phenol within 6months
- •11) Patients with any lower limb treatment using FES or the robot suit within 1month
- •12) Patients diagnosed not to use during the WA trial operation period
- •13) Patients who do not complete the WA trial operation for 7 days
- •14) Patients joining any other clinical trials or studies with intervention
研究者
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