jRCTs032180314已完成不适用
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)
未提供0 个研究点目标入组 200 人开始时间: 2016年8月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 85age old under（—）
- 性别
- All
入选标准
- •Patients who agree to participate in this study and provide their informed consent
- •Patients from 20 to 85 years old at the time of consent
- •Patients of convalescent stoke (within 6 months of onset)
- •Patients with a first episode of stroke, which type limited intracranial hemorrhage or ischemic stroke (excluding subarachnoid hemorrhage)
- •Patients inpatients for the rehabilitation therapy
- •Patients diagnosed 3 or 4 on Functional Ambulation Classification (FAC)
- •Patients stable general condition (blood pressure, pulse, blood glucose level etc.)
- •Patients with drop foot in walking
排除标准
- •Patients due to severe heart disease
- •Patients with previous gait disability, such as neurological disease
- •Patients with previous orthopedic disease, such as knee osteoarthritis
- •Patients with severe hepatic or renal dysfunction
- •Patients with severe sensory disturbance or severe ataxia or severe higher brain dysfunction
- •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)
- •Patients with severe skin disease
- •Patients with any dose adjustment of antispasticity drugs (tizanidine hydrochloride, eperisone hydrochloride, baclofen, etc.) within 1month
- •Patients whose impairment severities changed during the study period
- •Patients taking the botulinum toxin formulation injection or the nerve block injection with phenol within 6months
- •Patients with any lower limb treatment using FES or the robot suit within 1month
- •Patients diagnosed not to use during the WA trial operation period
- •Patients who do not complete the WA trial operation for 7 days
- •Patients joining any other clinical trials or studies with intervention
结局指标
主要结局
-
maximum walking distance of 6 Minute Walk Test (bare feet)
次要结局
- Stroke Impact Scale (SIS)
- Patient reported outcome measure (PRO)
- gait analysis by medical staff
- Adverse event assessment
- maximum walking distance of 6 Minute Walk Test (with WA)
- maximum walking distance of 6 Minute Walk Test (with AFO)
- walking speed of 10 Meter Walk Test (bare feet)
- walking speed of 10 Meter Walk Test (with WA)
- walking speed of 10 Meter Walk Test (with AFO)
- Fugl-Meyer assessment (FMA)
- modified Ashworth scale (MAS)
- range of motion
- Timed up and go test (bare feet)
- Timed up and go test (with AFO)
- Timed up and go test (with WA)
研究者
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