- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07695350
Kinesio Taping Versus Electrical Stimulation on Dysphagia in Bilateral Cerebral Palsy
6. juli 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Eman Wagdy
- E-mail: Eman.wagdy@pt.bsu.edu.eg
Undersøgelse Kontakt Backup
- Navn: Ahmed Hanfy
- E-mail: Ahmedhanfey911@gmail.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Oral Motor Skills
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
12. juli 2026
Primær færdiggørelse (Anslået)
12. oktober 2026
Studieafslutning (Anslået)
12. oktober 2026
Datoer for studieregistrering
Først indsendt
5. juli 2026
Først indsendt, der opfyldte QC-kriterier
6. juli 2026
Først opslået (Faktiske)
10. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FPTBSUREC/0411/15326
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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