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临床试验/NCT06840938
NCT06840938已完成1 期

Effects of Physiological Manipulation and Surface Electrical Stimulation Towards Safe Swallowing in Post Stroke Dysphagia Patients

Riphah International University1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
158
试验地点
1
主要终点
Severity of dysphagia

研究概览

简要总结

Dysphagia is common diagnosed problem after stroke in geriatric population. Digestive system is one of the key systems of human body in which the ingested food is broken down, softened and manipulated in the form of a bolus before actual swallowing. Later however the bolus reaches the stomach where the further disintegration of food is ascertained before it is sent out to intestines where actual absorption of nutrients takes place. A highly active neurological and physiological status ensures a safe travel of food from oral cavity to stomach which otherwise may pose risk of aspiration. Such debilitating conditions are more scientifically known as dysphagia and may present themselves in the form of challenges at oral, pharyngeal and esophageal levels. Although oropharyngeal phase is considered as the key factor leading to aspiration, severe dietary, nutritional and pulmonary challenges may also result. The rehabilitation and efficacy of treatment is seriously linked to an immaculate diagnosis and therapy options available. This study is dedicated to find the effects of present day options including physiological manipulation and surface electrical stimulations for patients who have had developed dysphagia as a result of stroke. It further aims to find the prevailing trends and options available to SLP's rendering services for dysphagia management.

The study is conceived utilizing a mixed method approach whereby both qualitative and quantitative designs will be benefitted. One population of the study comprise stroke patients in the age range of 30-65 years diagnosed to have dysphagia and seeking help at public and private hospitals in Lahore district. A purposive sampling technique will be utilized to select the sample. The sample will be divided into three experimental groups and will be subjected to different treatment options. The treatment will continue for a period of 12 weeks and later will be evaluated in pre-post comparisons in terms of severity of dysphagia. Data will be interpreted in terms of percentages, frequencies and means etc., etc. An inferential statistical comparison (one way Anova) will be conducted to find any significant difference in the treatment groups.

Another population of the study will comprise speech language professionals rendering services to dysphagic patients, conveniently sampled and interviewed. The qualitative analysis will yield information about present day options and preferences among SLP's for respective audience.

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
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •post stroke Dysphagia patients will be included.

排除标准

  • •Any other co-morbid condition (Parkinson disease, Alzheimer disease) will be excluded.
  • •Drug intake, History of Alcohol & Smoking will be excluded.

研究组 & 干预措施

Group A

Experimental

physiological (maneuvers and positioning)

干预措施: physiological maneuver (Behavioral)

Group B

Experimental

surface electrical stimulation

干预措施: Surface Electrical Stimulation (Device)

Group C

Active Comparator

combination of physiological and surface electrical stimulation

干预措施: Surface Electrical Stimulation (Combination Product)

结局指标

主要结局

Severity of dysphagia

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Nazia Mumtaz

Professor, Head Of Department Speech Language Pathology

Riphah International University

研究点 (1)

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