[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631611":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":36,"collaborators":38,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":25,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":25},{"fullName":5,"class":6},"University of Pavia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Robotic Treatment Group","ACTIVE_COMPARATOR","Participants receive conventional rehabilitation plus training with the 3DOF Balance Platform device. Both groups undergo 12 conventional rehabilitation sessions of at least 30 minutes each, three times per week, according to usual clinical practice. Participants in this group additionally receive 3DOF Balance Platform sessions of up to 15 minutes each under therapist supervision.",[13],"Device: 3DOF balance board robotic platform group",{"label":15,"type":6,"description":16,"interventionNames":17},"Control Group","Participants receive conventional rehabilitation only, according to usual clinical practice. Both groups undergo 12 conventional rehabilitation sessions of at least 30 minutes each, three times per week.",[18],"Other: Conventional Rehabilitation",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","3DOF balance board robotic platform group","The 3DOF balance platform system distinguishes itself by providing controlled perturbations across three degrees of freedom: roll, pitch, and vertical translation (heave), the latter being a unique feature for enhancing proprioceptive stimulation. The platform integrates a markerless motion capture system that tracks the patient's Center of Mass in real-time without wearable sensors.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Conventional Rehabilitation","Traditional rehabilitative treatment delivered according to usual clinical practice at the participating centers. Participants undergo 12 sessions of at least 30 minutes each, three times per week.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Christian Lunetta, MD","CONTACT","+39 02 50725266","christian.lunetta@icsmaugeri.it",{"type":37,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[39],{"name":40,"class":6},"Istituti Clinici Scientifici Maugeri SpA","100631611","a-multicenter-interventional-study-on-the-use-of-a-3-degree-of-freedom-3dof-platform-to-evaluate-the-safety-and-usability-of-the-system-and-its-impact-on-balance-proprioception-and-neurological-deficits-in-the-rehabilitation-of-patients-with-neurological-disorders-100631611",false,"NCT07502937","A Multicenter Interventional Study on the Use of a 3-Degree-of-Freedom (3DOF) Platform to Evaluate the Safety and Usability of the System and Its Impact on Balance, Proprioception, and Neurological Deficits in the Rehabilitation of Patients With Neurological Disorders.","3DOF","Inclusion Criteria:\n\n* Patients: adults aged 18 to 80 years.\n* Patients: confirmed diagnosis of one of the following chronic neurological conditions: stroke, Parkinson's disease, amyotrophic lateral sclerosis (ALS), or mild cognitive impairment (MCI).\n* Patients: able to understand and follow study procedures and provide informed consent.\n* Healthy volunteers: adults aged 18 to 65 years.\n* Healthy volunteers: able to understand and follow study procedures and provide informed consent.\n* Healthy volunteers: rehabilitation staff members from the participating centers.\n\nExclusion Criteria:\n\n* Patients: severe psychiatric disorders or cognitive disorders that impair the ability to complete cognitive tests and self-report questionnaires.\n* Patients: unable to provide informed consent.\n* Patients: moderate to severe cognitive impairment, defined as an ECAS score below 81.92 in participants with ALS or a Raven's Matrices score below 18.36 in participants with mild cognitive impairment.\n* Patients: neurological or physical conditions that significantly limit lower-limb use and prevent standing on the platform, including lower-limb muscle strength of 3 or less on the Medical Research Council (MRC) scale.\n* Patients: body weight greater than 100 kg.\n* Patients: current or recent participation, within the last 3 months, in other rehabilitation programs or interventions that could affect study results.\n* Patients: alcohol or substance dependence that could compromise safety during training sessions.\n* Patients: unstable health conditions that could make use of the 3DoF Platform and\u002For head-mounted display unsafe or inappropriate, such as severe cardiovascular disease, severe respiratory disease, or other unstable medical conditions.\n* Healthy volunteers: health conditions that could make use of the 3DoF Platform and\u002For head-mounted display unsafe or inappropriate, such as severe cardiovascular disease, severe respiratory disease, or other unstable medical conditions.\n* Healthy volunteers: any motor disability.",true,"ALL","18 Years","80 Years",{"count":53,"type":54},60,"ESTIMATED","INTERVENTIONAL",[57],"NA","This multicenter interventional study aims to evaluate a three-degrees-of-freedom dynamic platform (3DoF Platform) designed to support rehabilitation of balance, proprioception, and motor and cognitive functions in patients with neurological disorders. The device integrates a mobile platform capable of roll, pitch, and vertical translation movements, a markerless motion-capture system, and an interactive environment delivered through a monitor or virtual reality headset. Compared with conventional rehabilitation systems, it offers an additional vertical degree of freedom and increased proprioceptive stimulation, with the ability to customize exercises according to individual patient capabilities. The clinical conditions under investigation include Parkinson's disease, post-stroke motor impairment, amyotrophic lateral sclerosis, and mild cognitive impairment, all of which are associated with deficits in balance and proprioception. The novelty of this study lies in the combined use of the 3DoF platform, the markerless acquisition system, and exergames integrated with a mathematical model that adapts the platform's dynamic response in real time. The primary objective is to assess the usability, feasibility, and safety of the device. Secondary objectives include evaluating the impact of the intervention on balance, motor performance, cognitive functions, stress, fatigue, and quality of life, as well as comparing conventional rehabilitation with and without the addition of the device. The study involves 45 patients and 15 healthy volunteers and is structured into an initial phase of testing on healthy subjects and a subsequent randomized two-arm treatment phase for patients.",[60,61],"Neurological Disorders","Health Adult Subjects",[63,64,65,66],"3DoF Platform","proprioception","exergame","neurological rehabilitation","NOT_YET_RECRUITING","2026-03-31",{"date":70,"type":71},"2026-04-06","ACTUAL",{"date":73,"type":54},"2026-04",{"date":75,"type":54},"2026-11",{"name":5,"class":6}]