Acute Stroke Patients With Dysphagia After Different Swallowing Therapies: Videofluoroscopy Findings and Brain Plasticity in Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 主要终点
- The functional oral intake scale
研究概览
简要总结
Dysphagia after stroke is associated to increased pulmonary complications and mortality. The swallowing therapies could decrease the pulmonary complications and improve the quality of life after stroke. The swallowing therapies include dietary modifications, thermal stimulation, compensatory positions, and oropharyngeal muscle stimulation. Most researchers used clinical assessments and videofluoroscopy to evaluate the effect of the swallowing therapies. Some authors performed functional magnetic resonance imaging (fMRI) to investigate the brain neuroactivity during swallowing with tasks in normal adults and unilateral hemispheric stroke patients. The aim of this study is to explore the effect of swallowing therapies not only in clinical swallowing function but also brain plasticity of acute stroke patients with dysphagia by videofluoroscopy and fMRI.
详细描述
In the study, 10 healthy controls and 48 patients with a single and acute hemispheric or brain stem stroke will be enrolled. Both 24 hemispheric and 24 brain stem stroke patients will be divided into 3 groups. General swallowing therapy, oropharyngeal neuromuscular electrical stimulation (NMES), and combined general and NMES therapies will be randomly provided for the 3 groups. Each patient will receive clinical assessment of food oral intake scale, functional dysphagia scale of videofluoroscopy, and brain neuroactivity in fMRI.
The investigators hope to find the benefit of the swallowing therapies both in clinical swallowing function and in brain functional neuroactivity/reorganization after acute stroke. While comparing the 3 swallowing therapies, different functional neuroactivity may be facilitated by different swallowing therapies. Finally, the investigators could also find out the most effective swallowing therapy among the 3 therapies in acute stroke patients with dysphagia according to the findings of videofluoroscopy and fMRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •of normal controls:
- •normal neurological examination
- •no history of stroke
- •no active neurological disorder
- •Inclusion criteria of hemispheric stroke patients:
- •a single cerebral hemispheric stroke
- •swallowing difficulty: detected by bedside swallow assessment by a physician while admitting to the rehabilitation unit.
- •Inclusion criteria of these brain stem stroke patients:
- •a single brain stem stroke without prior stroke history
- •swallowing difficulties: detected by bedside swallow assessment by a physician while admitting to the rehabilitation unit
排除标准
- •multiple brain lesions due to one episode of stroke
- •impaired communication ability due to cognition deficit
- •other central or peripheral neurological deficit leading to swallowing difficulty.
- •use of an electrically sensitive biomedical device (eg. cardiac pacemaker)
- •metal clip in the brain
- •pneumonia at the time of enrollment.
结局指标
主要结局
The functional oral intake scale
时间窗: baseline (before intervention), changes from baseline FOIS at 4 weeks
Clinical swallowing evaluations: The functional oral intake scale (FOIS) was reported by Crary et al. for presenting the functional oral intake of food and liquid in stroke patients. One physician who is blinded to the therapies will evaluate the FOIS for each participant before and after swallowing treatments.
次要结局
- 8-point penetration-aspiration scale (PAS)(baseline (before intervention), changes from baseline PAS score at 4 weeks)
- 11-item functional dysphagia scale (FDS)(baseline (before intervention), changes from baseline FDS score at 4weeks)
- 3-Dimensional (3D) structural MRI(baseline (before intervention), changes from baseline result of 3-Dimensional (3D) structural MRI at 4 weeks)
- Function MRI(baseline (before intervention), changes from baseline result of fMRI at 4 weeks)
- Diffusion tensor imaging(baseline (before intervention), changes from baseline result of diffusion tensor imaging at 4 weeks)