Use Of A Tongue Strength Training Device And Its Relationship With Speech In Patients With Parkinson's Disease

NCT06921122 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-10

No results posted yet for this study

Summary

Parkinson's Disease affects the brain and causes several movement problems. These problems include stiff muscles, slow movements, shaking when resting, and trouble keeping balance. As the disease gets worse, it can also affect how people speak.

Doctors and therapists have found better ways to test how Parkinson's affects speech. There's one special therapy method that's considered the best for helping people with Parkinson's speak better. Now, they're also using a new tool called IOPI (Iowa Oral Performance Instrument) to help test and treat speech problems.

This research project wants to see if using IOPI can help people with Parkinson's speak better. Here's how they'll do it:

First, they'll split people with Parkinson's into two groups randomly. Everyone will take speech tests, like:

Holding an "a" sound as long as they can; Saying "pataka" repeatedly; Counting from 1 to 15; Reading sentences; Speaking freely about a topic; They'll also measure how strong their tongue is using IOPI. Then, one group will get therapy using the IOPI tool, while the other group won't. After the therapy is done, they'll test everyone again to see if the IOPI therapy helped improve their speech.

The researchers hope this study will show that IOPI is a helpful new tool for speech therapy, giving therapists more ways to help people with Parkinson's speak better.

Conditions

  • Parkinson Disease (PD)

Interventions

DEVICE

IOWA ORAL PERFORMANCE INSTRUMENT

In the first session all protocols and assessments will be carried out as a way of observing the responses and previous measures of all participants. The group in this study must appear weekly for six weeks to verify if necessary, reinsufflate the bulb, carry out force measurement and lingual press with the IOPI, as well as receive or reinforce the guidance provided at the beginning of the treatment. The participants in the group will study that will have a mobile phone and an instant message application will receive weekly, on scheduled days, a letter containing the following text message: "Here is the day of performing the last exercise by the Speech Pathologist". Participants who do not have a mobile phone will be notified through a telephone connection or contact with a responsible family member/caregiver. After the end of the sixth week of training, patients will be subjected to the last set of data on the two protocols and evaluations proposed in this study.

DEVICE

Placebo Group - Without Treatment

The group in study, without treatment, supported by the same schedule of the patients treated, will represent the natural progression of failure disorders in PD. A decision was made not to include a false treatment, in order to adhere to the principle of balance and not to place an undue burden of time and effort on patients who receive a treatment with low therapeutic potential. Furthermore, the researchers considered that given the questions regarding the adequacy of simulations as comparators of treatment in behavioral studies, research in this work between the group in the study and the placebo group (without treatment) can provide more useful contrasts than a group with therapeutic simulation. If the intervention clearly aims to provide direct benefits to the participants, this group will be contacted to carry out the same intervention later.

Sponsors & Collaborators

  • Federal University of Rio Grande do Sul

    collaborator OTHER
  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Amanda L Bressanelli, Academic · Federal University of Rio Grande do Sul

  • Vitória M Santos, Academic · Federal University of Rio Grande do Sul

  • Maira R Olchik, Teacher · Federal University of Rio Grande do Sul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2026-12-20
Completion
2028-06-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06921122 on ClinicalTrials.gov