- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07255352
Effekten av Kinesio Taping applicerat på suprahyoidmusklerna på sväljsäkerheten hos patienter med poststroke dysfagi (Post-Stroke KT)
Undersökning av effekterna av suprahyoid Kinesio Taping på sväljsäkerhet och hyolaryngeal elevation hos patienter med poststroke dysfagi
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Sanliurfa, Turkiet (Türkiye)
- Harran University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Hyolaryngeal Kinematic Displacement (Hyoid and Laryngeal Displacement)
Tidsram: Immediately before and immediately after Kinesio taping application.
|
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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Swallowing Safety (Penetration-Aspiration Scale Score)
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HRÜ/24.14.41
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .