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Results of Combined Medical and Swallowing Behavioral Readjustment Therapy in Oropharyngeal Dysphagia Management Among Parkinson's Patients

25 mei 2026 bijgewerkt door: Amany Saeed Hassan Abo Salem, Tanta University

Evaluation of the Results of Combined Medical and Swallowing Behavioral Readjustment Therapy in Oropharyngeal Dysphagia Management Among Parkinson's Patients

The study aims to assess the efficacy of using swallowing behavioral readjustment technique in combination with medical treatment in management of oropharyngeal dysphagia among Parkinson's patients in order to improve the management protocol

Studie Overzicht

Gedetailleerde beschrijving

Parkinson's disease is the second most common neurodegenerative disorder with an estimated prevalence of 6.1 million individuals all over the world.

Parkinson's disease is characterized by motor features such as tremor, rigidity and bradykinesia, and several non-motor features such as dysphagia, autonomic dysfunction, sleep disorders, cognitive impairment, depression, and psychosis that may occur at any time during the disease course, but become more frequent with advanced disease. Dysphagia in Parkinson's disease is a manifestation of swallowing dysfunction that may involve oral, pharyngeal or esophageal phases of swallowing and may be present in every stage of the disease. Indeed, even though swallowing disorders become apparent mostly in the advanced stage of Parkinson's disease, they may already be present in the early stages, when they often go undetected.

The mechanism of dysphagia in Parkinson's disease is unclear. Studies have shown that in the progression of Parkinson's disease, a variety of pathological changes occur in the neuromuscular associated with swallowing function, resulting in impaired central and peripheral swallowing regulation mechanisms, and eventually swallowing disorders (.Both dopaminergic and non-dopaminergic mechanisms can be involved in dysphagia pathophysiology of parkinsonian syndromes In this regard, bradykinetic swallowing abnormalities, related to the nigrostriatal dopamine deficiency, are commonly observed as early findings of dysphagia in these disorders.

Parkinson's disease can impair all phases of swallowing. Dysphagia in the oral phase of Parkinson's disease patients is characterized by difficulties in the initiation of swallow, oral residues, piecemeal swallow and premature falling of the food; the pharyngeal phase is characterized by regurgitation of food into the nasal cavity or upper pharynx, pharyngeal residue and penetration/aspiration, and the esophageal phase is characterized by reduced esophageal peristalsis. Another distinctive feature in parkinsonian syndromes is the incomplete or absent relaxation of the cricopharyngeal muscle during the pharyngeal phase of swallowing, as possible consequence of brainstem involvement mostly in the advanced stages .Also there is recent evidence suggesting that time-to-laryngeal vestibule closure and airway responses to penetrated material are impacted by Parkinson's disease , greater evidence is needed to elucidate those physiological impairments for which treatment might have the greatest impact for swallowing safety and efficiency .

Treatments of dysphagia in Parkinson's disease include pharmaceutical, rehabilitation approaches and surgical . Pharmaceutical treatment is usually performed by the prescription of different dopaminergic medication ( levodopa, carbidopa , apomorphine , domperidone , and rotigotine . The effects of pharmaceutical treatment on improving motor functions of patients with Parkinson's disease are well demonstrated. However, contradictory results are reported on the effectiveness of pharmaceutical treatment on the swallowing function of patients with Parkinson's disease . As it has been suggested for many years that swallowing dysfunction is not related to nigrostriatal dopamine deficiency and may have a non-dopaminergic influence. Also there is botulinum toxin therapy which is new technique in patients who have well documented upper esophageal sphincter impairment . Another technique is botulinum toxin injection in parotid glands which leads to decrease sialorrhoea in patients with Parkinson's disease, but it has no effect on improving the swallowing function .

The study aims to assess the efficacy of using swallowing behavioral readjustment technique in combination with medical treatment in management of oropharyngeal dysphagia among Parkinson's patients in order to improve the management protocol

Studietype

Ingrijpend

Inschrijving (Werkelijk)

32

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Tanta, Egypte
        • Tanta University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • Patients with parkinson's disease based on established diagnostic criteria complaining of oropharyngeal dysphagia.

Exclusion Criteria:

  • Other significant medical conditions: Participants with significant medical conditions that could confound the assessment of dysphagia or its causes may be excluded.

    • Prior surgical interventions or interventions affecting swallowing.
    • Cognitive impairment: Parkinson's patients with severe cognitive impairments

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group (A)
Patients managed by combined pharmaceutical treatment and rehabilitation techniques for 6 months .
Group (A) managed by combined pharmaceutical treatment and rehabilitation techniques for 6 months .
Experimenteel: Group (B)
Patients managed by pharmaceutical treatment only
Group (B) managed by pharmaceutical treatment only

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fiberoptic Endoscopic Evaluation of Swallowing
Tijdsspanne: 6 months
Fiberoptic Endoscopic Evaluation of Swallowing involves passing a flexible endoscope through the nose to visualize the swallowing process directly. It allows for a detailed assessment of the structures involved in swallowing and can detect abnormalities or dysfunctions, such as reduced laryngeal elevation or penetration/ aspiration events .
6 months

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Complications as bleeding
Tijdsspanne: 6 months
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 augustus 2023

Primaire voltooiing (Werkelijk)

30 augustus 2024

Studie voltooiing (Werkelijk)

30 augustus 2024

Studieregistratiedata

Eerst ingediend

25 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

25 mei 2026

Laatst geverifieerd

1 augustus 2023

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

It will be available if it needed

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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