The Changes of Masticatory / Swallowing Functions and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Training and Tongue - Pressure Resistance Training in Stroke Patients With Dysphagia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- the change from baseline to time of tongue muscles thickness
研究概览
简要总结
The aims of this study are:
- Comparing the ultrasound imaging performance of swallowing and chewing function, tongue pressure and oropharyngeal muscle thickness in stroke patients with different levels of swallowing function
- To explore the changes in clinical mastication and swallowing functions, tongue pressure and oropharyngeal muscle thickness in patients with dysphagia and stroke after swallowing treatment and neuromuscular electrical stimulation training.
- To explore the correlation between clinical mastication and swallowing functions, tongue pressure, oropharyngeal muscle thickness and ultrasound imaging results in patients with dysphagia and stroke.
详细描述
After acute stroke, 25∼45% of patients show difficulties in swallowing, which is associated with a high risk of pneumonia, malnutrition, and mortality. In addition to traditional swallowing therapies for post-stroke dysphagia (PSD), the Iowa Oral Performance Instrument (IOPI) is used to provide tongue exercise program which improving swallowing function. In rehabilitation unit, ultrasound is a convenient tool and is more widely used in investigating oropharyngeal muscles mass and quality in PSD. Therefore, the investigators hope to assess the effects on swallowing function and oropharyngeal muscle mass on sonography after IOPI swallowing training in PSD. In this study, 60 stroke patients with or without dysphagia will be enrolled. Each patient will receive clinical assessments of swallowing and tongue functions, general and oropharyngeal muscles mass and quality by sonography, and life quality. Furthermore, the investigators'll enrolled 50 stroke patients with dysphagia and they will be randomly allocated in two groups. the investigators will provide two interventions including general swallowing therapy, and combined simple and IOPI therapies. First, the investigators will investigate the differences of swallowing and tongue functions, oropharyngeal muscles on sonography in patients with or without PSD. The effects of the swallowing therapies in masticatory and swallowing function, tongue pressure, oropharyngeal muscle mass, and life quality will be explored in PSD by using different swallowing therapies. The investigators will find out the most effective swallowing therapy from these 2 interventions for PSD. Furthermore, the investigators could explore that sonography is a clinically practical tool for assessing oropharyngeal muscles mass and quality in PSD.
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
- Single (Participant)
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
- •Stroke patients with hemiplegia that are diagnosed with or without dysphagia (FOIS1-7)
- •The duration since the onset of stroke should be within 6 months.
- •The ages of participants should be from 18 to 80 years old.
排除标准
- •The stroke duration is more than 6 months after stroke
- •Aged younger than 18 or older than 80 years old
- •Any cognitive deficit that leads to communicative difficulty.
- •Any other history of systemic diseases that are associated with swallowing difficulty.
研究组 & 干预措施
The IOPI group
tongue muscle strengthening and endurance exercises by using 15-min IOPI biofeedback program. The biofeedback will be 50%-60% of maximal strength
干预措施: swallowing therapy (Other)
The IOPI group
tongue muscle strengthening and endurance exercises by using 15-min IOPI biofeedback program. The biofeedback will be 50%-60% of maximal strength
干预措施: IOPI therapy (Other)
The general swallowing group
oral exercises, tongue movement, and compensatory techniques, swallowing maneuvers and food modifications, will be performed by an experienced speech and language therapist during intervention
干预措施: swallowing therapy (Other)
结局指标
主要结局
the change from baseline to time of tongue muscles thickness
时间窗: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
For the tongue muscles, the probe will be placed on the point of the lower chin surface be performed at the maximal cross-section area of the muscles in both longitudinal and transverse planes. The measurements were performed 3 times, and expressed as the mean.
the change from baseline to time of swallowing muscle strength
时间窗: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
the evaluation would be executed by an experienced speech and language therapist. The target muscles include tongue and lip strength and endurance.
the change from baseline to time of Masster thickness
时间窗: baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments
The measurement of masseter thickness would be placed at the most prominent area of the masseter muscle in longitudinal and transverse planes. The measurements will be taken during relaxation and maximal jaw clenching (2 conditions). The measurements were performed 3 times, and the mean value would be adapted for further analysis.
次要结局
- the change from baseline to time of general muscle mass(baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments)
- the change from baseline to time of swallowing functions 100 ml water test(baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments)
- Measure the change in grip strength (by Jamar hand dynamometer)(baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments)
- the change from baseline to time of swallowing functions(baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments)
- the change from baseline to time of clinical nutrition status(baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments)
- the change from baseline to time of quality of life(baseline (before intervention), right after three-week intervention (time 1), and three-week post intervention (time 2) as follow-up assessments)