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

25. maj 2026 opdateret af: 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

Studieoversigt

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Tanta, Egypten
        • Tanta university

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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 .
Eksperimentel: Group (B)
Patients managed by pharmaceutical treatment only
Group (B) managed by pharmaceutical treatment only

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fiberoptic Endoscopic Evaluation of Swallowing
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tidsramme
Complications as bleeding
Tidsramme: 6 months
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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 (Faktiske)

30. august 2023

Primær færdiggørelse (Faktiske)

30. august 2024

Studieafslutning (Faktiske)

30. august 2024

Datoer for studieregistrering

Først indsendt

25. maj 2026

Først indsendt, der opfyldte QC-kriterier

25. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2026

Sidst verificeret

1. august 2023

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

It will be available if it needed

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Parkinson

Abonner