NCT07695350

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Jul 2026Oct 2026

First Submitted

Initial submission to the registry

July 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

July 12, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2026

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 5, 2026

Last Update Submit

July 6, 2026

Conditions

Keywords

Kinesio TapingElectrical StimulationDysphagiaBilateral Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    Up to 12 weeks

Study Arms (3)

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.

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.

Other: Structured Oromotor ExercisesOther: 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.

Other: Structured Oromotor ExercisesOther: Neuromuscular Electrical Stimulation

Interventions

The structured oromotor exercises will include cheek massage, gum massage, cheek Stretch, and lip stretch.

Kinesio tapingNeuromuscular Electrical StimulationStructured Oromotor Exercises

Kinesio taping will be applied on the suprahyoid and infrahyoid muscle in Y-shape.

Kinesio taping

Neuromuscular electrical stimulation will be applied on the suprahyoid and infrahyoid muscles with frequency of 80 HZ of 300 milliseconds with 1-second interval.

Neuromuscular Electrical Stimulation

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Eman Wagdy

CONTACT

Ahmed Hanfy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 10, 2026

Study Start

July 12, 2026

Primary Completion (Estimated)

October 12, 2026

Study Completion (Estimated)

October 12, 2026

Last Updated

July 10, 2026

Record last verified: 2026-07