Clinical trial NCT06921122: Use Of A Tongue Strength Training Device And Its Relationship With Speech In Patients With Parkinson's Disease
Official title: Use Of The Iowa Oral Performance Instrument In Speech Therapy Intervention In Individuals With Parkinson's Disease: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease (PD)
Keywords: Dysarhria
Speech Therapy
IOPI
Intervention
Parkinson Disease (PD)
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2025-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Effect of IOPI on the articulatory subsystem
timeFrame: 6 weeks
Secondary outcomes:
measure: Sociodemographic Variables
timeFrame: 6 weeks
Other outcomes:
measure: Unified Parkinson's Disease Rating Scale III - UPDRS III
timeFrame: 6 weeks
measure: Radboud Oral Motor Inventory for Parkinson's Disease - ROMP
timeFrame: 6 weeks
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Amanda L Bressanelli, Academic
role: STUDY_DIRECTOR
affiliation: Federal University of Rio Grande do Sul
name: Vitória M Santos, Academic
role: STUDY_CHAIR
affiliation: Federal University of Rio Grande do Sul
name: Maira R Olchik, Teacher
role: PRINCIPAL_INVESTIGATOR
References: