Clinical trial NCT06840938: Physiological Manipulation and Surface Electrical Stimulation in Post Stroke Dysphagia Patients
Official title: Effects of Physiological Manipulation and Surface Electrical Stimulation Towards Safe Swallowing in Post Stroke Dysphagia Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Dysphagia Following Cerebrovascular Accident
Keywords: Physiological Manipulation
Electrical Stimulation
Lead sponsor: Riphah International University
Sponsor class: OTHER
Collaborators: name: Mayo Hospital Lahore
First posted: 2025-02-21
Enrollment: 158
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* post stroke Dysphagia patients will be included.

Exclusion Criteria:

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

Primary outcomes:
measure: Severity of dysphagia
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Mayo Hospital
state: Punjab
Study officials:
References: