The Therapeutic Effects of Peroneal Nerve Functional Electrical Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 31
- 主要终点
- maximum walking distance of 6 Minute Walk Test (bare feet)
研究概览
简要总结
Among the sequelae of stroke, gait disorder is directly linked to the degree of autonomy in the daily life of patients. It is considered significant effects on their Quality of Life(QOL).
Further methods of rehabilitation are required for convalescent patients to recover their function soon and better, due to a multitudes of recovery patient with troubles such as gait problem.
This trial is studying to investigate the effects of gait training with a functional electrical stimulation (FES) 'WalkAide[R](WA)' to improve the lower-limb function and ambulation in convalescent stroke patients.
详细描述
This study is targeting convalescent patients within 6 months after the onset of initial stroke (cerebral infarction or cerebral hemorrhage) and also observing the foot drop during walking.
Some study for the patients after the onset of stroke (over several months) are reported that a case of the efficacy by the treatment using the FES, and another case of using FES indicated the equal efficacy and the higher QOL compared to using ankle-foot orthosis(AFO).
However, these are clinical research results overseas and there are not so many studies targeting only for convalescent stroke patients.
FES which recover the lost function by paralysis using electrical stimulation is recommended as convalescent rehabilitation by Japanese Guidelines for the Management of Stroke 2015 etc..
The purpose of FES treatment is the electrical stimulation to peroneal nerve of patients with foot drop and equinus foot due to central nervous system damage and the objective efficacy is following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 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
研究组 & 干预措施
WA
干预措施: WA group (Device)
Control
干预措施: Control (Other)
结局指标
主要结局
maximum walking distance of 6 Minute Walk Test (bare feet)
时间窗: 8weeks
Measuring maximum walking distance of 6 Minute Walk Test at baseline and after 8-weeks intervention. Calculating difference of those measured values. Targeting for all patients.
次要结局
- Stroke Impact Scale (SIS)(8weeks)
- maximum walking distance of 6 Minute Walk Test (with AFO)(8weeks)
- Fugl-Meyer assessment (FMA)(8weeks)
- maximum walking distance of 6 Minute Walk Test (with WA)(8weeks)
- walking speed of 10 Meter Walk Test (with AFO)(8weeks)
- Timed up and go test (bere feet)(8weeks)
- Timed up and go test (with AFO)(8weeks)
- Timed up and go test (with WA)(8weeks)
- Patient reported outcome measure (PRO)(8weeks)
- Adverse event assessment(8weeks)
- walking speed of 10 Meter Walk Test (bare feet)(8weeks)
- walking speed of 10 Meter Walk Test (with WA)(8weeks)
- modified Ashworth scale (MAS)(8weeks)
- range of motion(8weeks)
- gait analysis by medical staff(8weeks)