Physiological Manipulation and Surface Electrical Stimulation in Post Stroke Dysphagia Patients

NCT06840938 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: Nazia MumtazArshad Mehmood Naz
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia Following Cerebrovascular Accident

Keywords

Physiological Manipulation; Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

• Severity of dysphagia

  12 weeks

Study Arms (3)

Group A

EXPERIMENTAL

physiological (maneuvers and positioning)

Behavioral: physiological maneuver

Group B

EXPERIMENTAL

surface electrical stimulation

Device: Surface Electrical Stimulation

Group C

ACTIVE COMPARATOR

combination of physiological and surface electrical stimulation

Combination Product: Surface Electrical Stimulation

Interventions

physiological maneuver BEHAVIORAL

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

Group A

Surface Electrical Stimulation DEVICE

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

Group B

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• post stroke Dysphagia patients will be included.

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead
• Mayo Hospital Lahore: collaborator

Study Sites (1)

Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Central Study Contacts

Nazia Dr. Mumtaz, PhD

CONTACT

+923335196500; Nazia.mumtaz@riphah.edu.pk

Arshad Mehmood Naz, MS

CONTACT

+923216447723; Arshed_slt@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head Of Department Speech Language Pathology

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 21, 2025
• Study Start: April 1, 2025
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

PA (1)