- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07695350
Kinesio Taping Versus Electrical Stimulation on Dysphagia in Bilateral Cerebral Palsy
July 6, 2026 updated by: Eman Wagdy, Beni-Suef University
Kinesio Taping Versus Neuromuscular Electrical Stimulation on Dysphagia in Children With Bilateral Spastic Cerebral Palsy. A Randomized Controlled Trial
The purpose of this study will be to compare the effect between kinesiotaping and neuromuscular electrical stimulation on dysphagia in children with bilateral spastic cerebral palsy.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Dysphagia is one of the most common feeding and swallowing problems associated with cerebral palsied children due to impaired neuromuscular control of the oral, pharyngeal, and respiratory muscles involved in swallowing.
It can result in serious complications such as aspiration, malnutrition, dehydration, prolonged feeding time, and recurrent respiratory infections, which in turn may negatively influence the child's nutritional status, growth, and overall quality of life.
Several rehabilitation approaches have been developed to improve swallowing function and feeding performance in cerebral palsied children.
However, there is little evidence directed toward which intervention procedure is more effective on dysphagia therefore, there is need to compare between the therapeutic effect of kinesiotaping versus neuromuscular electrical stimulation on dysphagia in children with bilateral spastic cerebral palsy.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eman Wagdy
- Email: Eman.wagdy@pt.bsu.edu.eg
Study Contact Backup
- Name: Ahmed Hanfy
- Email: Ahmedhanfey911@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Children ages will be ranged from 3 to 7 years old.
- They scored ≤10 on an initial evaluation of Oral Motor Assessment scale.
- They scored from 5 to 7 in accordance to dysphagia severity scale.
- Sufficient cognition to follow simple verbal instructions.
Exclusion Criteria:
- Congenital problems of mouth and soft plate (e.g: cleft lip and plate).
- Jaw anomalies.
- Gum and/or dental problems.
- Chest infection or unstable cardiopulmonary conditions.
- Uncontrolled seizures.
- History of recent surgery or trauma affecting the head, neck, or oral region.
- Skin allergies that prevent the application of kinesio-tape or electrical stimulation electrodes.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Structured Oromotor Exercises
Bilateral cerebral palsy children will receive structured oromotor exercises for 20 minutes.
The duration of treatment will be 3 times/week for 12 weeks.
|
The structured oromotor exercises will include cheek massage, gum massage, cheek Stretch, and lip stretch.
|
|
Experimental: Kinesio taping
Bilateral cerebral palsy children will receive structured oromotor exercises for 20 minutes in addition to kinesio tape on the suprahyoid and infrahyoid muscles.
The duration of treatment will be 3 times/week for 12 weeks.
|
The structured oromotor exercises will include cheek massage, gum massage, cheek Stretch, and lip stretch.
Kinesio taping will be applied on the suprahyoid and infrahyoid muscle in Y-shape.
|
|
Experimental: Neuromuscular Electrical Stimulation
Bilateral cerebral palsy children will receive structured oromotor exercises for 20 minutes in addition to neuromuscular electrical stimulation for 20 minutes.
The duration of treatment will be 3 times/week for 12 weeks.
|
The structured oromotor exercises will include cheek massage, gum massage, cheek Stretch, and lip stretch.
Neuromuscular electrical stimulation will be applied on the suprahyoid and infrahyoid muscles with frequency of 80 HZ of 300 milliseconds with 1-second interval.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral Motor Skills
Time Frame: Up to 12 weeks
|
Oral Motor Assessment Scale will be used to assess oral motor skills.
It is a reliable scale consists of seven items compromising oral-motor skills (Mouth closure, Lip closure onto the utensil, lip closure during degluition, control of the food during degluition, straw suction, contol of liquids during degluition, and mastication) that are scored from 0 to 3 (0-passive, 1-sub-functional, 2-semi-functional, and 3-functional).
|
Up to 12 weeks
|
|
Swallowing Function
Time Frame: Up to 12 weeks
|
Pediatric Eating Assessment Tool (PEDIEAT-10) will be used to assess swallowing function.
It is an eating screener tool include 10-items (gags with smooth food like pudding, insists on being fed by the same person(s), has to be reminded to chew food, shows more stress during meals than during non-meal times (whines, cries, gets angry, tantrums), refuses to eat, is willing to feed self (if younger in age, holds cup, feeds self crackers), throws up during mealtime, arches back during or after meals, gets tired from eating and is not able to finish, and gags when it is time to eat (for example, when they see food or when placed in high chair)) that scored from never to always (never, almost never, sometimes, often, almost always, and always).
|
Up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 12, 2026
Primary Completion (Estimated)
October 12, 2026
Study Completion (Estimated)
October 12, 2026
Study Registration Dates
First Submitted
July 5, 2026
First Submitted That Met QC Criteria
July 6, 2026
First Posted (Actual)
July 10, 2026
Study Record Updates
Last Update Posted (Actual)
July 10, 2026
Last Update Submitted That Met QC Criteria
July 6, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPTBSUREC/0411/15326
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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