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

NCT06921122 | Not Yet Recruiting

• 1 other identifier: 20240194
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Dysarhria; Speech Therapy; IOPI; Intervention; Parkinson Disease (PD)

Outcome Measures

Primary Outcomes (1)

• Effect of IOPI on the articulatory subsystem

  The investigator determines the safe target value for therapy purposes and provides specific instructions to the subject. The target value definition will be expressed by means of an algebraic formula, based on the internationally recognized unit of pressure, the Pascal (Pa). Strength is measured with the IOPI by quantifying the length of time that a patient can maintain 50% of his or her maximum pressure. This procedure is conducted by setting the target value in the Target Mode to 50% of the patient's maximum pressure and timing how long the patient can hold the top (green) light on. There is considerable variability in tongue strength in a population of adults reporting no swallowing or speech problems. There is a clear central tendency, however, with an average maximum pressure of about 60 kPa, and a range of 40-80 kPa.

  6 weeks

Secondary Outcomes (1)

• Sociodemographic Variables

  6 weeks

Other Outcomes (2)

• Unified Parkinson's Disease Rating Scale III - UPDRS III

  6 weeks

• Radboud Oral Motor Inventory for Parkinson's Disease - ROMP

  6 weeks

Study Arms (2)

Iopi

EXPERIMENTAL

All individuals will perform a program of two lingual exercises: the first exercise consists of compressing the air-filled bulb between the tongue and the anterior portion of the hard palate using IOPI, in order to sustain the articulatory positioning for "p" (closed lips) and "t" (tongue tip behind upper teeth) and hold for 4 seconds. The second exercise consists of compressing this same bulb between the tongue and the posterior portion of the hard palate, performing 10 repetitions, 3 times a day on 3 days of the week, as recommended for strength training by the American College of Sports Medicine. These tongue locations were selected based on evidence of regional differences in lingual muscle composition, marked by a higher percentage of muscle tissue in the posterior region of the tongue that may respond differently to exercise.

Device: IOWA ORAL PERFORMANCE INSTRUMENT

Placebo

PLACEBO COMPARATOR

The study group, without treatment, evaluated on the same schedule as treated patients, will represent the natural progression of speech disorders in PD. The decision was made not to include a sham treatment, in order to adhere to the principle of balance and not place an undue burden of time and effort on patients who received a treatment with low therapeutic potential. Furthermore, the investigators considered that given questions about the suitability of simulations as treatment comparators in behavioral studies, the research in this work between study group and placebo group (no treatment) may provide more useful contrasts than a therapeutic simulation group. If an intervention proposal is proven to bring direct benefits to the participants, this group will be contacted to carry out the same intervention later.

Device: Placebo Group - Without Treatment

Interventions

IOWA ORAL PERFORMANCE INSTRUMENT DEVICE

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.

Iopi

Placebo Group - Without Treatment DEVICE

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All individuals with an age greater than or equal to 18 years who have been diagnosed with idiopathic PD attended at the Movement Disorders Outpatient and at the Speech Therapy Outpatient Degenerative Adult of a quaternary health care hospital.
• Who will participate in the project entitled Validation and applicability of the Test of Mastication and Swallowing Solids (TOMASS) for the Brazilian population with Parkinson's disease approved under No. 2023-0402.

You may not qualify if:

• Subjects who are not currently off the medication;
• Those whose serious alterations of language and cognition are unable to perform the proposed tasks;
• Those with other neurological conditions will be excluded.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Links

• Product Description

MeSH Terms

Conditions

Parkinson Disease; Communication Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Amanda L Bressanelli, Academic

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

• Vitória M Santos, Academic

  Federal University of Rio Grande do Sul

  STUDY CHAIR

• Maira R Olchik, Teacher

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maira R Olchik, PhD

CONTACT

5551991175920; molchik@hcpa.edu.br

Amanda L Bressanelli, Academic

CONTACT

5549991544565; amandalarabressanelli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: April 10, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)