Bilateral Spastic Cerebral PalsyNCT07695350
Kinesio Taping Versus Electrical Stimulation on Dysphagia in Bilateral Cerebral Palsy
A study testing Structured Oromotor Exercises, Kinesio Taping and Neuromuscular Electrical Stimulation in people with Bilateral Spastic Cerebral Palsy, run by Beni-Suef University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Bilateral Spastic Cerebral Palsy
- What is being tested?
- Structured Oromotor Exercises, Kinesio Taping and Neuromuscular Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 12 Jul 2026to 12 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Eman Wagdy contact
Ahmed Hanfy contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Bilateral Spastic Cerebral Palsy
- Being tested
- Structured Oromotor Exercises, Kinesio Taping, Neuromuscular Electrical Stimulation
- Keywords
- Kinesio Taping, Electrical Stimulation, Dysphagia, Bilateral Cerebral Palsy
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Oromotor ExercisesOther
The structured oromotor exercises will include cheek massage, gum massage, cheek Stretch, and lip stretch.
Kinesio TapingOther
Kinesio taping will be applied on the suprahyoid and infrahyoid muscle in Y-shape.
Neuromuscular Electrical StimulationOther
Neuromuscular electrical stimulation will be applied on the suprahyoid and infrahyoid muscles with frequency of 80 HZ of 300 milliseconds with 1-second interval.
| Study group | Role | What they receive |
|---|---|---|
| Structured Oromotor Exercises | Experimental | Bilateral cerebral palsy children will receive structured oromotor exercises for 20 minutes. The duration of treatment will be 3 times/week for 12 weeks. Receives: Other: Structured Oromotor Exercises |
| Kinesio taping | Experimental | 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. Receives: Other: Structured Oromotor Exercises; Other: Kinesio Taping |
| Neuromuscular Electrical Stimulation | Experimental | 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. Receives: Other: Structured Oromotor Exercises; Other: Neuromuscular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Motor Skills
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).
Measured: Up to 12 weeks
Swallowing Function
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).
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start12 Jul 2026 (estimated)
- Primary completion12 Oct 2026 (estimated)
- Study completion12 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Wagdy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695350
- Sponsor's protocol ID
- FPTBSUREC/0411/15326
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesio Taping Versus Neuromuscular Electrical Stimulation on Dysphagia in Children With Bilateral Spastic Cerebral Palsy. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07695350
- Acronym / sponsor ID
- FPTBSUREC/0411/15326
- Conditions
- Bilateral Spastic Cerebral Palsy
- Keywords
- Kinesio Taping, Electrical Stimulation, Dysphagia, Bilateral Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 12 Jul 2026 (estimated)
- Primary completion
- 12 Oct 2026 (estimated)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Structured Oromotor Exercises | Experimental | Other: Structured Oromotor ExercisesBilateral cerebral palsy children will receive structured oromotor exercises for 20 minutes. The duration of treatment will be 3 times/week for 12 weeks. |
| Kinesio taping | Experimental | Other: Structured Oromotor Exercises, Other: Kinesio TapingBilateral 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. |
| Neuromuscular Electrical Stimulation | Experimental | Other: Structured Oromotor Exercises, Other: Neuromuscular Electrical StimulationBilateral 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. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Oromotor ExercisesThe structured oromotor exercises will include cheek massage, gum massage, cheek Stretch, and lip stretch. | Other | Kinesio taping, Neuromuscular Electrical Stimulation, Structured Oromotor Exercises |
| Kinesio TapingKinesio taping will be applied on the suprahyoid and infrahyoid muscle in Y-shape. | Other | Kinesio taping |
| Neuromuscular Electrical StimulationNeuromuscular electrical stimulation will be applied on the suprahyoid and infrahyoid muscles with frequency of 80 HZ of 300 milliseconds with 1-second interval. | Other | Neuromuscular Electrical Stimulation |
Primary outcome
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eman Wagdy contact
Ahmed Hanfy contact
Questions about this trial
What is this clinical trial studying?
A study testing Structured Oromotor Exercises, Kinesio Taping and Neuromuscular Electrical Stimulation in people with Bilateral Spastic Cerebral Palsy, run by Beni-Suef University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman Wagdy (Eman.wagdy@pt.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Motor Skills (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.