- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07255352
Effekt av Kinesio-taping på suprahyoide muskler på svelgesikkerhet hos pasienter med dysfagi etter hjerneslag (Post-Stroke KT)
Undersøkelse av effektene av suprahyoid kinesiotaping på svelgesikkerhet og hyolaryngeal heving hos pasienter med dysfagi etter hjerneslag
Dysphagia is defined as a disorder that occurs during the process of food transfer, beginning with oral intake and continuing until it reaches the stomach. The incidence of post-stroke dysphagia has been reported to range between 42% and 75%. Dysphagia can lead to aspiration pneumonia due to food entering the lungs, as well as malnutrition, dehydration, and even death. In patients with inadequate swallowing safety and efficiency, compensatory maneuvers such as chin tuck, head flexion, supraglottic swallowing, and the Mendelsohn maneuver are commonly used. These maneuvers aim to maintain oral intake by narrowing the laryngeal vestibule or increasing hyolaryngeal elevation. They are evaluated during videofluoroscopic swallowing studies and recommended to patients if they are found to prevent aspiration or penetration.
Kinesio taping (KT) has been reported to stimulate cutaneous receptors, increase sensory input, and facilitate neural reflexes, thereby promoting the activation of a greater number of motor units during maximal muscle contraction. In recent years, it has also begun to be used in the field of dysphagia rehabilitation. Studies conducted in stroke patients have shown that KT applied to the infrahyoid muscles provides resistance to the suprahyoid muscles and enhances their strength. A kinematic analysis study in stroke patients reported that KT applied to include the suprahyoid muscles increased vertical hyoid movement, although it did not result in a significant improvement in swallowing safety. The study, however, did not specify the detailed taping method used. Since the suprahyoid muscles are primarily responsible for hyolaryngeal elevation, KT focusing on this region has the potential to serve as a compensatory maneuver in dysphagia management.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Sanliurfa, Tyrkia (Türkiye)
- Harran University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Diagnosis of stroke
- Age over 18 years
- Presence of swallowing disorder symptoms
- Willingness to participate in the study
Exclusion Criteria:
- Presence of neurological diseases other than stroke
- Presence of tracheostomy
- Open wounds on the skin in the submental region
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Kinesio Taping Group
Participants with post-stroke dysphagia will receive Kinesio Taping applied to the suprahyoid muscle region. Swallowing safety and kinematic parameters will be evaluated before and after the intervention. |
Kinesio tape will be applied over the suprahyoid region to facilitate muscle activation. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Hyolaryngeal Kinematic Displacement (Hyoid and Laryngeal Displacement)
Tidsramme: Immediately before and immediately after Kinesio taping application.
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Hyolaryngeal kinematic displacement will be assessed from videofluoroscopic swallowing study (VFSS) recordings using MATLAB-based STAMPS software. Anatomical landmarks (C2, C4, the subglottic air column, and the hyoid bone) will be digitized frame-by-frame to calculate hyoid and laryngeal displacement in the superior, anterior, and total (resultant) directions, yielding six kinematic parameters. Total displacement will be calculated as the square root of the sum of the squared anterior and superior displacement components. Spatial calibration will be performed using a 20 mm reference object placed on the mastoid process. Differences in these parameters between taped and non-taped swallowing trials will be analyzed to assess the acute effect of suprahyoid Kinesio taping on hyolaryngeal movement. |
Immediately before and immediately after Kinesio taping application.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Swallowing Safety (Penetration-Aspiration Scale Score)
Tidsramme: Immediately before and immediately after Kinesio taping application.
|
Swallowing safety will be evaluated using the Penetration-Aspiration Scale (PAS) during videofluoroscopic swallowing study (VFSS). Each swallow will be scored on an 8-point scale, with higher scores indicating a higher risk of airway invasion. The difference in PAS scores before and immediately after Kinesio taping will be analyzed to assess the acute effect of the intervention on swallowing safety. |
Immediately before and immediately after Kinesio taping application.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Esophageal sykdommer
- Otorhinolaryngologiske sykdommer
- Faryngeale sykdommer
- Slag
- Deglution lidelser
Andre studie-ID-numre
- HRÜ/24.14.41
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