Recruiting · registry status

A programme for swallowing difficulties

This study compares treatment approaches for people with Parkinson's who have difficulty swallowing.

Testing a treatment or activity · Study reference: RBR-5ddt474

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Results reported

Start (reported date): 2023-11-01
Study finished (reported date): 2025-03-31

Planned dates can move. A study finishing does not tell us when a paper will be published.

Read the results reported in the registry

Changes we have recorded

2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 18y to 0 · Ask the team who can join

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: -

Inclusion criteria: Adults treated at the Hospital Universitário Onofre Lopes (HUOL); aged >18 years; of both genders; diagnosed with Parkinson's; complaining of oropharyngeal dysphagia; who had not previously undergone speech therapy Exclusion criteria: Patients with coexistence of other neurological diseases; with head and neck cancer; tracheostomy users; using an alternative feeding route; those who are unable to follow commands

Full study name & original research details

Official study title

Effects of an intervention program in dysphagic patients with dysphagia Parkinson's

Short title used by the registry

Effects of an intervention program in patients with swallowing difficulties and Parkinson's

Original description

Intervention: Stratified randomization will be carried out, so that individuals with Parkinson's are randomly distributed into two groups (A or B), using an Excel® spreadsheet. The professional responsible for carrying out the randomization, explaining the procedures, as well as requesting consent from the participant, must be a different person from those responsible for the therapies and those responsible for the evaluation procedures, in order to ensure the uni-blind nature of the study. This study is a pilot clinical trial and therefore there will be a smaller number of participants. The sample size was calculated based on the survey of medical records in the survey that aims to encompass users treated at the Hospital Universitário Onofre Lopes (HUOL). Therefore, the sample was calculated based on the percentage of improvement in dysphagia symptoms of patients seen monthly at the service, where the data indicates an increase of 0.3 after the estimated period. To achieve 0.8 power for unpaired group testing, a sample size of 22 participants will be required to achieve detection of 0.8 improvement in dysphagia symptoms for a medium effect size of a = 0.05 . Our study will aim to recruit 26 participants to allow for 20% attrition. Individuals in Group A will undergo an initial assessment according to the procedures described below and will subsequently begin swallowing therapy with Chin-Down exercises with the provision of thickened liquids, which will last 8 weeks, with face-to-face consultations taking place at a once a week, totaling 8 therapy sessions. Individuals in Group B will carry out the first assessment in the same way, and will begin swallowing therapy with isometric chin tuck exercises against resistance, which will last 8 weeks, with face-to-face consultations taking ;E02.760.169.063.500.387 Primary outcome: Evaluate the signs and symptoms of dysphagia through clinical speech therapy assessment with food offered at the beginning and end of the study;Evaluate the signs and symptoms of dysphagia through video endoscopy of swallowing with the offer of different food consistencies at the beginning and end of the study ;Assess quality of life related to swallowing through self-reported protocols Secondary outcome: Evaluate isometric tongue pressure using the Iowa Oral Performance Instrument at the beginning and end of the study;Evaluate the vocal signal through an acoustic analysis of the Acoustic Voice Quality Index (AVQI) and Acoustic Brethiness Index (ABI) at the beginning and end of the study;Evaluate cough function through peak expiratory flow with the MicroLife PF100 portable device at the beginning and end of the study

Conditions reported: Deglutition Disorders; Parkinson Disease;C10.228.140.079.862

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

REBEC · RBR-5ddt474 ↗ — Recruiting; WHO ICTRP processed 2025-10-27; checked 2026-10-11

Study type: Interventional
Interventions: Stratified randomization will be carried out, so that individuals with Parkinson's are randomly distributed into two groups (A or B), using an Excel® spreadsheet. The professional responsible for carrying out the randomization, explaining the procedures, as well as requesting consent from the participant, must be a different person from those responsible for the therapies and those responsible for the evaluation procedures, in order to ensure the uni-blind nature of the study. This study is a pilot clinical trial and therefore there will be a smaller number of participants. The sample size was calculated based on the survey of medical records in the survey that aims to encompass users treated at the Hospital Universitário Onofre Lopes (HUOL). Therefore, the sample was calculated based on the percentage of improvement in dysphagia symptoms of patients seen monthly at the service, where the data indicates an increase of 0.3 after the estimated period. To achieve 0.8 power for unpaired group testing, a sample size of 22 participants will be required to achieve detection of 0.8 improvement in dysphagia symptoms for a medium effect size of a = 0.05 . Our study will aim to recruit 26 participants to allow for 20% attrition. Individuals in Group A will undergo an initial assessment according to the procedures described below and will subsequently begin swallowing therapy with Chin-Down exercises with the provision of thickened liquids, which will last 8 weeks, with face-to-face consultations taking place at a once a week, totaling 8 therapy sessions. Individuals in Group B will carry out the first assessment in the same way, and will begin swallowing therapy with isometric chin tuck exercises against resistance, which will last 8 weeks, with face-to-face consultations taking ;E02.760.169.063.500.387
Phases: N/A
Sponsor: Universidade Federal do Rio Grande do Norte
Start date reported by registry: 2023-11-01 (reported)

Registry updated: Not reported · Status last verified by the registry submitter: Not reported

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Ramon Araújo · +55 84 987253959 · ramon.pacheco.016@ufrn.edu.br

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Facility not reported

Brazil

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.