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

NCT ID: NCT06921122

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2028-06-01

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.

Detailed Description

Characterized by dopaminergic neurodegeneration, Parkinson's Disease (PD) manifests various motor symptoms, including: rigidity, bradykinesia, resting tremor, and postural instability, which impact the speech of affected individuals as they progress. Considerable advances have been made regarding speech assessment methods, and a globally recognized intervention model is used as the gold standard for speech-language therapy in individuals with Parkinson's Disease. However, currently, instruments such as the IOPI (Iowa Oral Performance Instrument Measures) have been gaining ground in the assessment and therapy of these subjects. Thus, this work aims to apply an intervention model for speech therapy in PD patients using IOPI as a treatment tool through a randomized clinical trial. This study will consist of three phases: The first phase will consist of random allocation of subjects between control and intervention groups. Sequentially, all subjects will undergo speech assessment using speech tasks: maximum phonation time through sustained vowel /a/, diadochokinesis of alternating syllables /pataka/, counting numbers from 1 to 15, sentence reading, and monologue, then IOPI will be used to verify the tongue pressure of participating subjects. The second phase will encompass therapy with the IOPI instrument in the intervention group, and the third phase will be the reassessment of subjects from both groups. It is considered that the findings of this study may contribute to the addition of new instruments to therapy and, thus, provide new approaches and expansion of the therapeutic perspective for the speech of subjects with PD.

Conditions

Parkinson Disease (PD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Iopi

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.

Group Type: EXPERIMENTAL

IOWA ORAL PERFORMANCE INSTRUMENT

Intervention Type: 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.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo Group - Without Treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda L Bressanelli, Academic

Role: STUDY_DIRECTOR

Federal University of Rio Grande do Sul

Vitória M Santos, Academic

Role: STUDY_CHAIR

Federal University of Rio Grande do Sul

Maira R Olchik, Teacher

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Central Contacts

Maira R Olchik, PhD

Role: CONTACT

molchik@hcpa.edu.br

5551991175920

Amanda L Bressanelli, Academic

Role: CONTACT

amandalarabressanelli@gmail.com

5549991544565

Related Links

https://iopimedical.com/

Product Description

Other Identifiers

20240194

Identifier Type: -

Identifier Source: org_study_id