[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550959":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":41,"locations":29,"responsibleParty":50,"collaborators":29,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":29,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":29,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":29,"overallStatus":71,"whyStopped":29,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":29},{"fullName":5,"class":6},"IRCCS National Neurological Institute \"C. Mondino\" Foundation","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Barefoot","ACTIVE_COMPARATOR","Participants will berform gait, postural and functional evaluations without wearing any shoes",[13],"Other: Barefoot",{"label":15,"type":16,"description":17,"interventionNames":18},"Neutral gym shoes","SHAM_COMPARATOR","Participants will be provided with appropriately sized neutral gym shoes, both for the acute evaluations and for assessment of one month longitudinal changes",[19],"Other: Neutral gym shoes",{"label":21,"type":10,"description":22,"interventionNames":23},"Greater plantar feedback shoes","Participants will be provided with appropriately sized plantar shoes, both for the acute evaluations and for assessment of one month longitudinal changes",[24],"Other: Greater plantar feedback shoes",[26,30,33],{"type":6,"name":21,"description":27,"armGroupLabels":28,"otherNames":29},"Shoes providing enhanced plantar feedback",[21],null,{"type":6,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"Regular gym shoes",[15],{"type":6,"name":9,"description":34,"armGroupLabels":35,"otherNames":29},"For the acute evaluation, barefoot will be considered as an active comparator for enhanced plantar feedback",[9],[37],{"name":38,"affiliation":39,"role":40},"Roberto MD De Icco","IRCCS, Mondino Foundation","PRINCIPAL_INVESTIGATOR",[42,46],{"name":38,"role":43,"phone":44,"phoneExt":29,"email":45},"CONTACT","+390382380425","roberto.deicco@mondino.it",{"name":47,"role":43,"phone":48,"phoneExt":29,"email":49},"Cinzia MD Fattore","+390382380385","cinzia.fattore@mondino.it",{"type":51,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100550959","effects-of-biofeedback-footwear-in-parkinsons-disease-assessment-of-functional-motor-abilities-and-locomotion-100550959",false,"NCT06453863","Effects of Biofeedback Footwear in Parkinson's Disease: Assessment of Functional Motor Abilities and Locomotion","Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease, according to the clinical diagnostic criteria of the Movement Disorders Society (Postuma RB, 2015);\n* Hoehn \\& Yahr between II and IV;\n* Stable medical therapy since at least one month before enrollment\n\nExclusion Criteria:\n\n* Concomitant diagnosis of other neurological or psychiatric disorders that may influence study assessments.;\n* MMSE score \\\u003C24;\n* Patients with DBS implant or on DuoDopa therapy;\n* Presence of relevant musculoskeletal or orthopedic pathologies;\n* Presence of relevant internal or vascular pathologies.","ALL","40 Years","80 Years",{"count":62,"type":63},40,"ESTIMATED","INTERVENTIONAL",[66],"NA","The study aims to verify whether the use of a specific footwear providing increased plantar feedback (plantar feedback shoes) could improve gait parameters, postural control and functional performances in people with Parkinson's disease.\n\nSpecifically, the aims are:\n\n* To evaluate the acute effect of plantar feedback shoes, by comparing gait, functional and postural performances in three conditions: neutral shoes, barefoot, and plantar feedback shoes;\n* To evaluate the effect of four weeks of plantar feedback shoes, on gait, functional and postural performances.\n\nParticipants will undergo a comprehensive neurological examination, with administration of disease-specific scales (UPDRS III part 3, NFOG-q, LEDD, DASS-21). At each assessment the participants will perform an inertial gait analysis, a static posturography, and will undergo functional capacity assessments (TUG, 2MWT, 5-STST, 10- mFW).",[69,70],"Parkinson Disease","Gait Disorders","NOT_YET_RECRUITING","2024-06-12",{"date":74,"type":75},"2024-06-13","ACTUAL",{"date":77,"type":63},"2024-07-01",{"date":79,"type":63},"2025-12-01",{"name":5,"class":6}]