[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586879":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":42,"locations":51,"responsibleParty":64,"collaborators":66,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":91,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Hospital de Clinicas de Porto Alegre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: IOWA ORAL PERFORMANCE INSTRUMENT",{"label":15,"type":16,"description":17,"interventionNames":18},"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.\n\nIf an intervention proposal is proven to bring direct benefits to the participants, this group will be contacted to carry out the same intervention later.",[19],"Device: Placebo Group - Without Treatment",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","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.\n\nThe 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\u002Fcaregiver.\n\nAfter 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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.\n\nIf the intervention clearly aims to provide direct benefits to the participants, this group will be contacted to carry out the same intervention later.",[15],[32,36,39],{"name":33,"affiliation":34,"role":35},"Amanda L Bressanelli, Academic","Federal University of Rio Grande do Sul","STUDY_DIRECTOR",{"name":37,"affiliation":34,"role":38},"Vitória M Santos, Academic","STUDY_CHAIR",{"name":40,"affiliation":34,"role":41},"Maira R Olchik, Teacher","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":26,"email":47},"Maira R Olchik, PhD","CONTACT","5551991175920","molchik@hcpa.edu.br",{"name":33,"role":45,"phone":49,"phoneExt":26,"email":50},"5549991544565","amandalarabressanelli@gmail.com",[52],{"facility":53,"status":26,"city":54,"state":55,"zip":26,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":26},"Hospital de Clínicas de Porto Alegre","Porto Alegre","Rio Grande do Sul","Brazil","BR",{"type":59,"coordinates":60},"Point",[61,62],-51.23019,-30.03283,{"lat":62,"lon":61},{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[67],{"name":34,"class":6},"100586879","use-of-a-tongue-strength-training-device-and-its-relationship-with-speech-in-patients-with-parkinsons-disease-100586879",false,"NCT06921122","Use Of A Tongue Strength Training Device And Its Relationship With Speech In Patients With Parkinson's Disease","Use Of The Iowa Oral Performance Instrument In Speech Therapy Intervention In Individuals With Parkinson's Disease: Randomized Clinical Trial","IOPI","Inclusion Criteria:\n\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Subjects who are not currently off the medication;\n* Those whose serious alterations of language and cognition are unable to perform the proposed tasks;\n* Those with other neurological conditions will be excluded.","ALL","18 Years",{"count":79,"type":80},60,"ESTIMATED","INTERVENTIONAL",[83],"NA","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.\n\nDoctors 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.\n\nThis research project wants to see if using IOPI can help people with Parkinson's speak better. Here's how they'll do it:\n\nFirst, they'll split people with Parkinson's into two groups randomly. Everyone will take speech tests, like:\n\nHolding 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.\n\nThe 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.",[86],"Parkinson Disease (PD)",[88,89,74,90,86],"Dysarhria","Speech Therapy","Intervention","NOT_YET_RECRUITING","2025-04-03",{"date":94,"type":95},"2025-04-10","ACTUAL",{"date":94,"type":80},{"date":98,"type":80},"2028-06-01",{"name":5,"class":6},1]