A Randomized Controlled Trial of NMES vs. Traditional Dysphagia Therapy After Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Full clinical response
研究概览
简要总结
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, 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. All patients will be treated for one hour per day for 3 weeks, and their progress and outcome will be monitored. 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.
详细描述
This pilot randomized controlled trial (N=51) includes stroke patients admitted to a sub-acute rehabilitation facility. Subjects will be clinically screened for dysphagia, and randomized into 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 recorded. Participants will be independently evaluated by a blinded assessor at baseline, post treatment and at 3 months following treatment. The primary outcome will be improvement in clinical swallowing ability, oral intake level, and body weight. The results will add to the preliminary data on the effectiveness of this form of swallowing treatment for patients following stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke identified by neurological and radiological examination
- •Oropharyngeal dysphagia as confirmed by clinical and radiological examination
- •No prior history of oropharyngeal dysphagia by patient and/or caregiver report
- •No previous head/neck surgery or trauma that may impact swallowing ability
- •No other/concomitant neurological disorders (e.g. Parkinson's disease) that would impact oropharyngeal swallowing ability. This does not include post-stroke deficits.
- •Physician and patient/family agreement to participate.
排除标准
- •Exposed to previous behavioral or NMES swallowing therapy within 6 months of admission
- •Presence of progressive neurological disorder, such as ALS; Parkinson's or other neurologic disorders within the last 6 months;
- •History of neurosurgery (either ablative or stimulatory), encephalitis or significant head trauma.
- •History of a significant medical condition such as heart, liver, or renal disease; history or evidence of malignancy within the past 5 years other than excised basal cell carcinoma.
- •Because of FDA Warnings, patients with cardiac demand pace makers will be excluded.
- •Patients with evidence of significant cognitive impairment or dementia as reflected in a Mini-Mental test less than 23 and/or a score of 50% or less on the comprehension quotient on the Western Aphasia Battery.
结局指标
主要结局
Full clinical response
时间窗: 3 months post treatment
Mann Assessment of Swallowing Ability (M.A.S.A)and Functional Oral Intake Scale (F.O.I.S) change, without significant weight loss or dysphagia-related complication.
Clinical response
时间窗: 3 weeks post treatment
Mann Assessment of Swallowing Ability (M.A.S.A)and Functional Oral Intake Scale (F.O.I.S) change, without significant weight loss or dysphagia-related complication
次要结局
- Dysphagia-related medical complications(Baseline,3 weeks ( post treatment) and 3 months post)
- Functional stroke recovery(Baseline, 3 weeks (post treatment) and at 3-months post treatment)
- Patient perception of swallowing ability(baseline, 3 weeks (post treatment) and at 3-months post treatment)
- Recovery of pre-stroke diet(Baseline, 3 weeks (post treatment) and 3 months post)
- Neurological status/Stroke severity(baseline, 3 weeks (post treatment) and at the 3-month post treatment)
- Biomechanic evaluation of swallowing function(Baseline and 3 weeks (post treatment))