NCT01876030Unknown不适用
Comparison of Different Treatment Methods for Gait Rehabilitation of Sub-Acute Post Stroke Patients With Dropped Foot
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in velocity of gait
研究概览
简要总结
The investigators hypothesize that the gait pattern of following the utilization of a functional electrical stimulation device will be much improved when compared to the effect of regular gait re-education with ankle-foot-orthosis (AFO) fitting in patients in early stages following stroke.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sub-acute stroke patients suffering a first stroke with clinical presentation, according to the WHO definitions
- •Patients suffering from unilateral foot drop
- •Independent ambulation before the stroke
- •Cognitive and cooperative ability to follow simple instructions
- •Neurological condition severity mild to moderate (between 3 and 15, according to the National Institutes of Health Stroke Scale; NIHSS).
- •Ability to walk with or without a walking aid (cane, walker), with or without assistance. Functional Ambulation Classification (FAC) of at least 2
- •Independently capable to understand an informed consent form.
排除标准
- •Cognitive disorders preventing the subject from understanding the trial protocol or following the researcher's instructions
- •Orthopaedic injury to the paretic or non-paretic limbs
- •Motor disability due to neurological diagnosis, e.g. multiple sclerosis, cerebral palsy, spinal cord injury, and Parkinson
- •Peripheral injury of the peroneal nerve or sciatic nerve
- •Pregnant or nursing females
结局指标
主要结局
Change in velocity of gait
时间窗: Baseline, 4 weeks and 12 week follwing baseline
Measured in m/s and the change will be in %
Change in step length
时间窗: Baseline, 4 and 12 weeks following baseline
Measured in cm and the change will be in %
次要结局
- Gait symmetry(Baseline, 4 and 12 weeks following baseline)
- Functional assessment(At baseline, 4 and 12 weeks following baseline)
- Muscle activity patterns(Baseline, 4 and 12 weeks following baseline)
研究者
研究点 (2)
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