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

描述（由申请人提供）：中风是美国第三大最常见的死亡原因和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）。吞咽困难通常与导致肺炎、住院时间延长和中风恢复较差的误吸有关。最近的研究表明，卒中后吞咽困难是一个普遍存在的问题，然而，吞咽困难的相关治疗是随机应用的，应用了不同程度的一系列干预措施。此外，尚不清楚这些技术是否有效（甚至有风险），因为很少有研究充分评估这些技术。用于吞咽的神经肌肉电刺激（NMES）最近被提出用于治疗中风后吞咽困难，并且在临床上作为治疗方式受到青睐，在缺乏强有力的研究支持的情况下，美国有超过7000名言语语言病理学家对中风患者进行这种治疗。本研究旨在探讨NMES治疗脑卒中后吞咽障碍对吞咽功能恢复的影响。本研究将遵循初步随机对照试验设计。将对51名入住亚急性康复机构的患者进行吞咽困难的临床筛查，并将其随机分配至三组之一，NMES、假NMES或常规护理-行为吞咽治疗组。随机分配后，所有受试者将接受吞咽视频X射线（改良钡剂吞咽）检查，以确认是否存在口咽吞咽困难，并提供有关吞咽困难性质和程度的客观数据。所有患者将每天接受1小时治疗，持续3周，并将监测其进展和结局。受试者将在基线、治疗后和治疗后3个月时由设盲评估员进行独立评估。将要求所有受试者填写日记卡，以记录治疗后和3个月随访审查之间状态或饮食的任何变化。主要结局将是临床吞咽能力、口服摄入水平和体重的改善。本研究中具有临床意义的改善被先验定义为Mann吞咽评估（MASA）增加10分或更多，功能性口服摄入量表（FOIS）改善≥ 2个量表分，且无显著体重减轻或吞咽困难相关并发症。次要结局包括吞咽生理学的改善（生物力学分析）、卒中前饮食的恢复以及吞咽困难相关医疗并发症的发生。这些结果将增加关于这种吞咽治疗形式对中风后患者有效性的初步数据，并有可能使资源更有效地分配给急性期后康复，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。这些结果将是非常宝贵的发展有效的管理策略和指导适当的卫生保健资源治疗卒中后吞咽困难。

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.