Use Of The Iowa Oral Performance Instrument In Speech Therapy Intervention In Individuals With Parkinson's Disease: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of IOPI on the articulatory subsystem
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: IOWA ORAL PERFORMANCE INSTRUMENT (Device)
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.
干预措施: Placebo Group - Without Treatment (Device)
结局指标
主要结局
Effect of IOPI on the articulatory subsystem
时间窗: 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.
次要结局
- Sociodemographic Variables(6 weeks)