Parkinson Disease (PD)IOPINCT06921122
Use Of A Tongue Strength Training Device And Its Relationship With Speech In Patients With Parkinson's Disease
A study testing IOWA ORAL PERFORMANCE INSTRUMENT in people with Parkinson Disease (PD), run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- IOWA ORAL PERFORMANCE INSTRUMENT
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Apr 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Use Of The Iowa Oral Performance Instrument In Speech Therapy Intervention In Individuals With Parkinson's Disease: Randomized Clinical Trial
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.
Read more
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.
Read the 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)
- Being tested
- IOWA ORAL PERFORMANCE INSTRUMENT, Placebo Group - Without Treatment
- Keywords
- Dysarhria, Speech Therapy, IOPI, Intervention, Parkinson Disease (PD)
- Medical subject headings
- Parkinson Disease, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOWA ORAL PERFORMANCE INSTRUMENTDevice
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 Group - Without TreatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo Group - Without Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
Sociodemographic Variables
The secondary objectives include correlating speech articulation data and IOPI training with variables such as age, sex, disease duration, and age at symptom onset. These variables will be collected through the application of a sociodemographic questionnaire. If the findings demonstrate a positive correlation, this may indicate the need for early speech therapy intervention in these patients, preventing the necessity of waiting for the disease to progress to more advanced stages.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start10 Apr 2025 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Amanda L Bressanelli, Academic, Study director, Federal University of Rio Grande do SulVitória M Santos, Academic, Study chair, Federal University of Rio Grande do SulMaira R Olchik, Teacher, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921122
- Sponsor's protocol ID
- 20240194
- Acronym
- IOPI
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of The Iowa Oral Performance Instrument In Speech Therapy Intervention In Individuals With Parkinson's Disease: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06921122
- Acronym / sponsor ID
- IOPI / 20240194
- Conditions
- Parkinson Disease (PD)
- Keywords
- Dysarhria, Speech Therapy, IOPI, Intervention, Parkinson Disease (PD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iopi | Experimental | Device: IOWA ORAL PERFORMANCE INSTRUMENTAll 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. |
| Placebo | Placebo comparator | Device: Placebo Group - Without TreatmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOWA ORAL PERFORMANCE INSTRUMENTIn 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 | Iopi |
| Placebo Group - Without TreatmentThe 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. | Device | Placebo |
Primary outcome
Effect of IOPI on the articulatory subsystem
Time frame: 6 weeks
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.
1 secondary outcome
Sociodemographic Variables
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Product DescriptionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda L Bressanelli, Academic study director
Federal University of Rio Grande do Sul
Vitória M Santos, Academic study chair
Federal University of Rio Grande do Sul
Maira R Olchik, Teacher principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOWA ORAL PERFORMANCE INSTRUMENT in people with Parkinson Disease (PD), run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maira R Olchik, PhD (5551991175920, molchik@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of IOPI on the articulatory subsystem (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.