Physiological Manipulation and Surface Electrical Stimulation in Post Stroke Dysphagia Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-12-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Dysphagia Following Cerebrovascular Accident

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

physiological (maneuvers and positioning)

Group Type EXPERIMENTAL

physiological maneuver

Intervention Type BEHAVIORAL

Group A will be subjected to physiological and postural trainings (traditional)

Group B

surface electrical stimulation

Group Type EXPERIMENTAL

Surface Electrical Stimulation

Intervention Type DEVICE

Group B will be subjected to Surface Electrical Stimulation through the use of electrodes and stimulators.

Group C

combination of physiological and surface electrical stimulation

Group Type ACTIVE_COMPARATOR

Surface Electrical Stimulation

Intervention Type COMBINATION_PRODUCT

Group C will be subjected to both physiological and Surface Electrical Stimulation supports.

Interventions

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physiological maneuver

Group A will be subjected to physiological and postural trainings (traditional)

Intervention Type BEHAVIORAL

Surface Electrical Stimulation

Group B will be subjected to Surface Electrical Stimulation through the use of electrodes and stimulators.

Intervention Type DEVICE

Surface Electrical Stimulation

Group C will be subjected to both physiological and Surface Electrical Stimulation supports.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No