Comparison of Different Treatment Methods for Gait Rehabilitation of Sub-Acute Post Stroke Patients With Dropped Foot
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 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
研究组 & 干预措施
FES
All subjects will receive a 15-30 minutes a day treatment for 5 days a week. When the subjects achieves the ability to walk with supervision, but with no physical assistance, safely and consistently during the physiotherapy sessions, then either the FES will be provided to the subject to allow ongoing gait practice with the nursing staff in the ward environment. After discharge, the assistive device will be provided for home usage till the end of the research.
干预措施: FES (Device)
Conventional
Treated with regular gait re-education with or without AFO fitting. All subjects will receive a 15-30 minutes a day treatment for 5 days a week. When the subjects achieves the ability to walk with supervision, but with no physical assistance, safely and consistently during the physiotherapy sessions, then either the AFO will be provided to the subject to allow ongoing gait practice with the nursing staff in the ward environment. After discharge, the assistive device will be provided for home usage till the end of the research.
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)