A randomized trial of NMES vs. traditional dysphagia therapy after stroke

描述(申请人提供)：中风是美国第三大常见死亡原因，也是导致长期残疾的主要原因。中风的常见并发症是吞咽困难(吞咽困难)。吞咽困难通常与吸入导致肺炎、住院时间延长和中风恢复较差有关。最近的研究表明，中风后的吞咽困难是一个广泛流行的问题，然而，吞咽困难的相关治疗是随意应用的，应用了不同程度的干预措施。此外，目前还不清楚这些技术是否有效(甚至是有风险)，因为很少有研究对这些技术进行充分评估。吞咽神经肌肉电刺激(NMES)最近被提出用于治疗中风后吞咽困难，并作为一种治疗方式在临床上受到青睐，美国有7000多名言语语言病理学家在缺乏强有力的研究支持的情况下对中风患者进行这种治疗。本研究旨在探讨NMES治疗卒中后吞咽困难对吞咽功能恢复的影响。这项研究将遵循试点随机对照试验设计。51名住进亚急性康复机构的患者将接受吞咽困难的临床筛查，并随机分为三组：NMES组、Sham NMES组或常规护理行为吞咽治疗组。随机化后，所有受试者都将接受吞咽的视频x光(改良吞钡)，以确认口咽吞咽困难的存在，并提供有关吞咽困难的性质和程度的客观数据。所有患者将接受为期3周的每天1小时的治疗，并将监测他们的进展和结果。参与者将在基线、治疗后和治疗后3个月由盲法评估员进行独立评估。所有受试者将被要求完成一张日记卡，以记录治疗后至3个月随访期间状态或饮食的任何变化。主要结果将是临床吞咽能力、口服摄入量和体重的改善。对这项研究有临床意义的改善被定义为先验的，即在Mann吞咽评估(MASA)上增加10分或更多，在功能性口服进食量表(FOIS)上增加=2分，没有明显的体重减轻或与吞咽困难相关的并发症。次要结果包括吞咽生理的改善(生物力学分析)，中风前饮食的恢复，以及与吞咽困难相关的内科并发症的发生。这一结果将增加关于这种形式的吞咽治疗对中风后患者的有效性的初步数据，并有可能使资源更有效地分配到急性康复后，从而使中风患者和社区受益。公共卫生相关性：这项随机临床试验将确定NMES对吞咽的益处。这些结果对于制定有效的管理策略和指导适当的卫生保健资源治疗中风后的吞咽困难将是非常宝贵的。

DESCRIPTION (provided by applicant): Stroke is the third most common cause of death and leading cause of long-term disability in the USA. A common complication of stroke is difficulty swallowing (dysphagia). Dysphagia is often associated with aspiration leading to pneumonia, prolonged hospital stay and poorer recovery from stroke. Recent studies reveal that dysphagia following stroke is a widely prevalent problem, however the associated treatments for dysphagia are applied haphazardly, with variable degrees of a range of interventions applied. Further it is not clear whether those techniques applied are effective (or even risky), because few studies have adequately evaluated these techniques. Neuromuscular Electrical stimulation (NMES) for swallowing has recently been proposed for the treatment of dysphagia post stroke and is clinically receiving favor as a treatment modality, with over 7000 speech language pathologists in the USA conducting this treatment with stroke patients, in the absence of strong research support. This study aims to investigate the effect of NMES therapy for dysphagia upon recovery of swallowing function following stroke. The study will follow a pilot randomized controlled trial design. Fifty one patients admitted to a sub-acute rehabilitation facility will be clinically screened for dysphagia, and randomized into one of three groups, NMES, sham NMES or usual care - behavioral swallowing therapy arm. Following randomization, all subjects will undergo a video-x-ray (modified barium swallow) of swallowing to confirm the presence of oropharyngeal dysphagia and provide objective data about the nature and degree of dysphagia. All patients will be treated for one hour per day for 3 weeks, and their progress and outcome will be monitored. Participants will be independently evaluated by a blinded assessor at baseline, post treatment and at 3 months following treatment. All subjects will be asked to complete a diary card to record any change in status or diet between the post treatment and 3 month follow up reviews. The primary outcome will be improvement in clinical swallowing ability, oral intake level, and body weight. Clinically meaningful improvement for this study is defined a priori, as an increase of 10 or more points on the Mann Assessment of Swallowing (MASA) and improvement of =2 scale points on the Functional Oral Intake scale (FOIS), without significant weight loss or dysphagia-related complications. Secondary outcomes include the improvement in the physiology of swallowing (biomechanical analysis), recovery of a pre-stroke diet, and the occurrence of dysphagia-related medical complications. The results will add to the preliminary data on the effectiveness of this form of swallowing treatment for patients following stroke, and has the potential to enable more efficient allocation of resources to post-acute rehabilitation and thus benefit afforded to stroke patients, and the community. PUBLIC HEALTH RELEVANCE: This randomized clinical trial will determine the benefit of NMES for swallowing. These results will be invaluable in developing effective management strategies and directing appropriate health care resources for the treatment of dysphagia following stroke.