Post Stroke Dysphagia: Effect of Adding Brain Neuromodulation to Conventional Therapy on the Prevalence of Stroke Associated Pneumonia.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- The Gugging swallowing screen (GUSS)
研究概览
简要总结
BACKGROUND: Dysphagia is one of the most life-threatening stroke complications. Dysphagic stroke patients are at increased risk of aspiration pneumonia. Pneumonia accounts for at least 10% of post stroke deaths within 30 days of hospitalization after stroke. rTMS is effective in improving post-stroke dysphagia and swallowing coordination after stimulation of the unaffected hemisphere, however it's efficacy on the prevalence of pneumonia has not yet been examined.
Purpose of the study: To determine the effect of adding low frequency repetitive transcranial magnetic stimulation to conventional oropharyngeal physical therapy program on the prevalence of aspiration pneumonia in in patients with post stroke dysphagia.
详细描述
Seventy acute ischemic stroke patients with oropharyngeal dysphagia from both sexes will represent the sample of this study. They will be diagnosed by a neurologist and stroke diagnosis was confirmed by brain MRI and/or CT. They will be selected from the stroke unit El Kasr El Ainy hospital, Cairo university.
Patients will be randomly assigned into two equal groups, the control group (A) and the study group (B). Control group (GA) will be treated using a designed physical therapy intervention for oropharyngeal dysphagia consists of a selected physical therapy rehabilitation program for oropharyngeal muscles in addition to sham repetitive transcranial magnetic stimulation. Study group (GB) will receive low frequency (1 Hz) rTMS to the contra-lesional cerebral hemisphere in addition to the same Oropharyngeal physical therapy program for dysphagia as in group A.
Modified Mann Assessment of Swallowing Ability (MASA) will initially used to confirm dysphagia in acute stroke. The Gugging swallowing screening (GUSS) test will be used to detect aspiration risk. A2DS2 scale will be used to detect stroke associated pneumonia (SAP). Criteria of modified Center for Disease Control and Prevention (CDC) will be used to assess SAP via assessing 4 main measures (body temperature (BT), Total Leukocyte count (TLC), Arterial blood gases (ABG), and Respiratory Rate (RR) .
The whole Intervention will consist of 12 sessions, 3 days /week for 4 consecutive weeks , Total duration of the session (TMS + PT session) will be from 40min to 60 min.
Primary & secondary outcomes will be assessed at the baseline and immediately after the completion of the whole treatment program.
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)
盲法说明
Patients participated will be masked about the type of intervention, where (GA) patients will receive PT program + sham repetitive transcranial magnetic stimulation, while patients in (GB) will receive low frequency (1 Hz) rTMS to the contralesional cerebral hemisphere in addition to the same Oropharyngeal physical therapy program for dysphagia as in group A.
入排标准
- 年龄范围
- 49 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients were diagnosed of stroke oropharyngeal dysphagia by a neurologist. Sever to moderate dysphagia (GUSS 0-14).
- •Severity of stroke ranged from mild to moderate according to NIHSS score (NIHSS less than or equal 16).
- •Patients' age ranged from 49 to 65 years old.
- •Patients had the ability to understand and follow instructions.
- •Patients were able to sit in upright position.
排除标准
- •History of previous stroke.
- •History of any swallowing problem.
- •History of any head and neck surgery or tumor that causes swallowing dysfunction.
- •Any lung disease or pneumonia on admission.
- •Patients with cognitive deficits or disturbed conscious level.
- •Patients on mechanical ventilator.
- •Patients with sensory or global aphasia.
结局指标
主要结局
The Gugging swallowing screen (GUSS)
时间窗: Baseline and immediately after the intervention.
It's a valid and a reliable bedside screening test to detect dysphagia and aspiration risk. The GUSS has 100% sensitivity. It begins with simple indirect swallow screen then if the total score is reached a direct swallowing test is done. It's composed of three parts: semisolid swallowing trial, liquid swallowing trial and solid swallowing trial. GUSS total score is 20. The score of the preliminary or the direct test is five. If the total score is reached the direct test can be done. Each subitem in the direct test has a score of five points. Each item of them requires the previous item to be completed.
(A2DS2) scale to detect risk of pneumonia
时间窗: Baseline and immediately after the intervention.
A2DS2 scale is used to detect stroke associated pneumonia (SAP). Consists of five items of scale which are: age, atrial fibrillation, dysphagia, sex and stroke severity. Total score of A2DS2 is 10. A2DS2 scoring tool: age more than 75 years=1, atrial fibrillation=1, dysphagia=2, male sex=1; stroke severity: is detected by NIHSS score. If NIHSS score is from 0-4=0, 5-15=3, and more than16=5. Patients with score of 6 or more are at high risk of pneumonia.
Microbiological Examination of the sputum
时间窗: Baseline and immediately after the intervention
Sputum specimens collected on sterile sputum containers by patient self-expectoration or aspiration should be checked for quality in a bacteriology laboratory. Quality check typically includes calculating the number of leukocytes (WBC) and buccal squamous epithelial (BSE) cells in the 100× view field .
次要结局
- Respiratory Rate (RR)(Baseline and immediately after the intervention.)
- Arterial Blood Gas (ABG) Test to assess Oxygen Saturation (OS)(Baseline and immediately after the intervention.)
- Total Leukocyte Count (TLC)(Baseline and immediately after the intervention.)
- Body Temperature(Baseline and immediately after the intervention.)
研究者
Engy Badreldin Saleh Moustafa, PhD
Lecturer of Physical Therapy for Neurology and Neurosurgery
Cairo University