Home-based tele-supervising rehabilitation for brain infarction patients (HTRBIP): study protocol for a randomized controlled trial
Home-based tele-supervising rehabilitation for brain infarction patients (HTRBIP): study protocol for a randomized controlled trial
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DOI：
10.1186/s13063-015-0585-5
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发表时间：
2015-02-25
期刊：
影响因子：
2.5
通讯作者：
Ren, Chuancheng
中科院分区：
文献类型：
--
作者：
Jin, Wei;Chen, Jing;Ren, Chuancheng
背景：脑梗死具有较高的发病率、死亡率和致残率，给全社会带来了巨大的经济和健康负担。虽然以前的一些研究表明远程康复可以促进中风幸存者在家康复，但临床应用的证据不足；此外，尚无试验评估远程康复对脑梗死患者的疗效。因此，需要更多的高质量的试验为这种新的康复策略提供实践证据。方法/设计：基于招募标准，本评估盲、平行随机对照试验将招募210例脑梗死患者。参与者被随机分为两组，分别接受家庭远程监护康复和常规康复。在干预结束和90天随访时进行结果测量。其中，Barthel指数评价作为主要结局指标，次要结局指标包括NIHSS评分、mRS评分、3盎司水吞试验和表面肌电图。在整个试验过程中，不良事件也将被记录下来，用于安全性评估。讨论：HTRBIP试验将评估基于家庭远程监控的脑梗死患者康复的有效性和安全性。有望为远程康复的应用提供新的依据。
Background: With high morbidity, mortality and disability rate, brain infarction brings a huge economic and health burden to the whole society in China. Although some previous studies suggested that telerehabilitation may facilitate rehabilitation for stroke survivors at home, the evidence is insufficient for clinical application; additionally, as yet no trial evaluates efficacy of telerehabilitation for brain infarction patients. Therefore, more high quality trials are needed to provide practice evidence for this novel rehabilitation strategy.Methods/Design: Based on recruitment criteria, this assessor blinded, paralleled randomized controlled trial will recruit 210 brain infarction patients. After being randomly allocated into two groups, participants will receive home-based tele-supervising rehabilitation or conventional rehabilitation. Outcome measurement will be conducted at the end of intervention and 90-day follow-up. Among which, Barthel index assessment will be considered as primary outcome measurement, secondary outcome measurements include NIHSS score, mRS score, 3-oz water swallow test and surface electromyography. Adverse events will also be recorded during the whole process of the trial for safety assessment.Discussion: The HTRBIP trial will evaluate efficacy and safety of home-based tele-supervising rehabilitation for brain infarction patients. It is expected to provide new evidence for telerehabilitation application.