NCT07618637

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Last Updated

June 1, 2026

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

May 25, 2026

Last Update Submit

May 25, 2026

Conditions

Keywords

Swallowing Behavioral ReadjustmentMedicalDysphagiaOropharyngealManagement

Outcome Measures

Primary Outcomes (1)

  • Fiberoptic Endoscopic Evaluation of Swallowing

    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

Secondary Outcomes (1)

  • Complications as bleeding

    6 months

Study Arms (2)

Group (A)

EXPERIMENTAL

Patients managed by combined pharmaceutical treatment and rehabilitation techniques for 6 months .

Behavioral: combined pharmaceutical treatment and rehabilitation techniques

Group (B)

EXPERIMENTAL

Patients managed by pharmaceutical treatment only

Drug: pharmaceutical treatment only

Interventions

Group (A) managed by combined pharmaceutical treatment and rehabilitation techniques for 6 months .

Group (A)

Group (B) managed by pharmaceutical treatment only

Group (B)

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

May 25, 2026

First Posted

June 1, 2026

Study Start

August 30, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

June 1, 2026

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

It will be available if it needed

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations