功能性电刺激
医学
物理医学与康复
随机对照试验
康复
物理疗法
生活质量(医疗保健)
冲程(发动机)
可视模拟标度
重复措施设计
上肢
日常生活活动
心理干预
功能训练
刺激
外科
机械工程
内科学
工程类
统计
护理部
数学
精神科
作者
Xu Yang,Fengyi Wang,Yi Chen,Lin Qiu,Lin Yang,Li Xize,Liu Shaxin,Yonghong Yang
出处
期刊:Trials
[Springer Nature]
日期:2024-06-04
卷期号:25 (1)
标识
DOI:10.1186/s13063-024-08199-2
摘要
Abstract Introduction About 17–80% stroke survivors experience the deficit of upper limb function, which strongly influences their independence and quality of life. Robot-assisted training and functional electrical stimulation are commonly used interventions in the rehabilitation of hemiplegia upper extremities, while the effect of their combination remains unclear. The aim of this trial is to explore the effect of robot-assisted upper limb training combined with functional electrical stimulation, in terms of neuromuscular rehabilitation, compared with robot-assisted upper limb training alone. Methods Individuals ( n = 60) with the first onset of stroke (more than 1 week and less than 1 year after stroke onset) will be considered in the recruitment of this single-blinded, three-arm randomized controlled trial. Participants will be allocated into three groups (robot-assisted training combined with functional electrical stimulation group, robot-assisted training group, and conventional rehabilitation therapies group) with a ratio of 1:1:1. All interventions will be executed for 45 min per session, one session per day, 5 sessions per week for 6 weeks. The neuromuscular function of the upper limb (Fugl-Meyer Assessment of upper extremity), ability of daily life (modified Barthel Index), pain (visual analogue scale), and quality of life (EQ-5D-5L) will be assessed at the baseline, at the end of this trial and after 3 months follow-up. Two-way repeated measures analysis of variance will be used to compare the outcomes if the data are normally distributed. Simple effects tests will be used for the further exploration of interaction effects by time and group. Scheirer-Ray-Hare test will be used if the data are not satisfied with normal distribution. Discussion We expect this three-arm randomized controlled trial to explore the effectiveness of robot-assisted training combined with functional electrical stimulation in improving post-stroke upper limb function compared with robot-assisted training alone. Trial registration Effect of upper limb robot on improving upper limb function after stroke, identifier: ChiCTR2300073279. Registered on 5 July 2023.
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