[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589512":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":32,"studyPopulation":33,"armGroups":34,"interventions":28,"overallOfficials":28,"centralContacts":41,"locations":50,"responsibleParty":65,"collaborators":28,"id":69,"slug":28,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":28,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":28,"enrollmentInfo":77,"targetDuration":28,"studyType":80,"phases":28,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":53,"whyStopped":28,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"General University Hospital, Prague","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":28},[9,13,15,17,19],{"measure":10,"description":11,"timeFrame":12},"Voluntary peak cough flow","Assessments will be performed in accordance with American Thoracic Society\u002FEuropean Thoracic Society guidelines.","baseline, 12months, 24months, 36months",{"measure":14,"description":11,"timeFrame":12},"Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)",{"measure":16,"description":11,"timeFrame":12},"Forced vital capacity (FVC)",{"measure":18,"description":11,"timeFrame":12},"Forced expiratory volume (FEV1)",{"measure":20,"description":11,"timeFrame":12},"Peak expiratory flow (PEF)",[22,25],{"measure":23,"description":24,"timeFrame":12},"Hand grip strength","The assessment of hand grip strength will be conducted according to the recommendations of the American Society of Hand Therapists. A digital hand dynamometer will be used.",{"measure":26,"description":27,"timeFrame":12},"Index of Pulmonary Dysfunction (IPD)","The screening assessment using the IPD questionnaire will involve the evaluation of four clinical indicators. The first two are direct questions asked to the patient regarding mucus management and cough strength. The third item is the strength of the voluntarily induced cough, subjectively assessed by the examiner. The fourth item tests the patient's ability to count out loud for as long as possible after a maximum inspiratory effort.",null,{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":30,"timePerspective":31,"maskingInfo":28},"CASE_CONTROL","PROSPECTIVE","The primary aim of the study will be to verify the potential relationship between forward trunk flexion, respiratory muscle strength, and the strength of voluntary cough.\n\nHypotheses:\n\n1. Forward trunk flexion in patients with Parkinson's disease (PD) will negatively affect respiratory muscle strength and the strength of voluntary cough.\n2. Respiratory muscle strength and the strength of voluntary cough will deteriorate more rapidly over a three-year period in patients with PD and forward trunk flexion than in patients with PD without forward trunk flexion.\n\nThe secondary aim will be to correlate respiratory muscle strength and the strength of voluntary cough with handgrip strength and the pulmonary dysfunction index as potential screening methods.\n\nHypothesis:\n\n1\\. Handgrip strength and the pulmonary dysfunction index will correlate with respiratory muscle strength and the strength of voluntary cough.","For this study, participants will be selected from patients with Parkinson's Disease who are being monitored at the Extrapyramidal Center of the Neurology Clinic and the Center for Clinical Neuroscience at the First Faculty of Medicine, Charles University, and the General University Hospital in Prague.",[35,38],{"label":36,"type":28,"description":37,"interventionNames":28},"Patients with Parkinson's disease","Participants of both groups will attend a total of five visits. During each visit, the participants will undergo a complete assessment including respiratory muscle strength, cough strength, dynamic spirometry, grip strength via a digital hand dynamometer, and evaluation of pulmonary dysfunction using the Index of Pulmonary Dysfunction (IPD) questionnaire. Each examination will last approximately 20 minutes, with no specific training or additional procedures required between visits.",{"label":39,"type":28,"description":40,"interventionNames":28},"Patients with Parkinson's disease and forward trunk flexion","Patients with pathological forward trunk flexion defined as thoracic (≥25°) or lumbar flexion (\\>15°) in standing and walking, which completely disappears in the supine position.\n\nParticipants of both groups will attend a total of five visits. During each visit, the participants will undergo a complete assessment including respiratory muscle strength, cough strength, dynamic spirometry, grip strength via a digital hand dynamometer, and evaluation of pulmonary dysfunction using the Index of Pulmonary Dysfunction (IPD) questionnaire. Each examination will last approximately 20 minutes, with no specific training or additional procedures required between visits.",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Kateřina Dvořáková, MSc.","CONTACT","+420 224 965 513","katerina.dvorakova@vfn.cz",{"name":48,"role":44,"phone":49,"phoneExt":28,"email":28},"Martin Srp, PhD.","+420224965513",[51],{"facility":52,"status":53,"city":54,"state":28,"zip":55,"country":56,"countryCode":28,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"General University Hospital","RECRUITING","Prague","12000","Czechia",{"type":58,"coordinates":59},"Point",[60,61],14.42076,50.08804,{"lat":61,"lon":60},[64],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Kateřina Dvořáková","Physiotherapist","100589512",false,"NCT06955377","Effect of Trunk Flexion on Airway Defense in Parkinson's Disease","Effect of Forward Trunk Flexion in Patients With Parkinson's Disease on the Airway Defense System","Inclusion Criteria:\n\n* Diagnosis of Parkinson' s disease\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Unreliable performance of MIP, MEP, or grip strength measurements, for example, due to cognitive deficits (assessed by the researcher)\n* Inadequate lip seal\n* Significant deformities of the dominant hand that could affect the accuracy of grip strength measurements\n* Other severe neurological diseases apart from PD\n* History of unstable cardiovascular disease\n* Severe pulmonary disease","ALL","18 Years",{"count":78,"type":79},100,"ESTIMATED","OBSERVATIONAL","The main mechanisms of airway protection include a properly functioning swallowing process and a cough. Studies focusing on patients with Parkinson's disease (PD) have previously demonstrated impairments in both swallowing (dysphagia) and coughing (dystussia). Aspiration pneumonia is the leading cause of death in individuals with PD.\n\nSwallowing function is directly related to body posture. Postural abnormalities (PA) are a common symptom of PD and significantly contribute to patient disability, affect respiratory function, and reduce quality of life. Previous research has shown that more than 20% of PD patients suffer from some form of PA.\n\nMost PD patients with a forward trunk flexion angle greater than 30 degrees report specific difficulties, such as dysphagia. A link has previously been demonstrated between postural abnormalities associated with flexed posture and restrictive ventilatory impairment. It can be assumed that this restrictive ventilatory impairment, which reduces the amount of air the patient can inhale into the lungs and subsequently exhale, negatively affects the strength of voluntary cough. However, this hypothesis has not yet been verified in the mentioned patient group.\n\nThe primary aim of the study will be to examine the effect of forward trunk flexion (FTF) in Parkinson's disease on the airway defense system.",[83],"Parkinson Disease",[83,85,86],"Postural abnormalities","Airway defense system","2025-04-30",{"date":89,"type":90},"2025-05-02","ACTUAL",{"date":92,"type":90},"2025-02-18",{"date":94,"type":79},"2029-02",{"name":5,"class":6},1]