[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643698":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":26,"responsibleParty":44,"collaborators":46,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":26,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":26},{"fullName":5,"class":6},"University of Pavia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Therapy","ACTIVE_COMPARATOR","Ten patients with similar upper limb functional impairment (Parkinson's Disease, Amyotrophic Lateral Sclerosis, and post-stroke sequelae) and five patients with or without upper limb functional impairment but affected by early cognitive impairment (Mild Cognitive Impairment, MCI) will undergo conventional rehabilitation therapy only. In particular, they will receive 12 sessions of conventional rehabilitation therapy (60 minutes each, three times per week).",[13],"Other: conventional therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Robotic Therapy","EXPERIMENTAL","Ten patients with upper limb motor functional impairment, as assessed by the QuickDASH scale with scores ranging from 20 to 90, due to chronic neurological diseases (Parkinson's Disease and Amyotrophic Lateral Sclerosis) or post-acute conditions (post-stroke sequelae), and five patients with or without upper limb motor functional impairment but affected by early cognitive impairment (Mild Cognitive Impairment, MCI), will receive treatment sessions using the investigational device in addition to conventional rehabilitation therapy sessions. In particular, they will receive 12 sessions of conventional rehabilitation therapy (60 minutes each, three times per week) in addition to training sessions with the investigational robotic device. Device sessions will last up to 30 minutes and will be supervised by rehabilitation staff. Exercise difficulty will be adapted according to the participant's performance.",[19],"Device: Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational Rehabilitation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational Rehabilitation","Participants will receive 12 sessions of conventional rehabilitation therapy (60 minutes each, three times per week) in addition to training sessions with the investigational robotic device. Device sessions will last up to 30 minutes and will be supervised by rehabilitation staff. The investigational robotic system provides adaptive upper limb rehabilitation exercises tailored to the patient's motor performance. Training includes task-oriented reaching exercises combined with cognitive tasks requiring target sequence memorization, as well as trajectory-tracking exercises in which the robot guides the patient's hand along predefined movements recorded by the therapist. Exercise difficulty is progressively adjusted according to patient performance during previous sessions.",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"conventional therapy","Participants will receive conventional rehabilitation therapy according to standard clinical practice for upper limb motor rehabilitation. Treatment sessions will last 60 minutes, three times per week, for a total of 12 sessions.",[9],[32,35],{"name":33,"affiliation":5,"role":34},"Antonella Ferrara, PhD","STUDY_DIRECTOR",{"name":36,"affiliation":37,"role":38},"Cira Fundarò, MD","Istituti Clinici Scientifici Maugeri SpA","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":26,"email":43},"CONTACT","+393348941743","cira.fundaro@icsmaugeri.it",{"type":45,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[47],{"name":37,"class":6},"100643698","auto-calibrating-system-for-upper-limb-disability-assessment-neurological-and-occupational-rehabilitation-100643698",false,"NCT07636538","Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation","Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation (AS-ULDAR)","ASULDAR","Inclusion Criteria:\n\n* Adult patients aged between 18 and 80 years.\n* Confirmed diagnosis of one of the following neurological conditions: stroke, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), or Mild Cognitive Impairment (MCI).\n* Presence of upper limb motor impairment defined by QuickDASH scores ranging from 20 to 90.\n* Ability to understand and follow the study protocol instructions.\n\nExclusion Criteria:\n\n* Patients with severe psychiatric disorders or cognitive impairments that interfere with the ability to complete cognitive tests and self-assessment scales.\n* Individuals unable to provide informed consent.\n* Subjects with moderate to severe cognitive impairment, defined by an ECAS score lower than 81.92 (ALS patients) or a MoCA score between 18 and 25.\n* Physical conditions significantly limiting upper limb use (e.g., severe concomitant orthopedic disorders affecting shoulder movement).\n* Current or recent participation (within the previous three months) in other rehabilitation programs or interventions that could influence study outcomes.\n* Unstable health conditions that could make device use unsafe or inappropriate, including unstable medical conditions or severe visual impairments.","ALL","18 Years","80 Years",{"count":60,"type":61},30,"ESTIMATED","INTERVENTIONAL",[64],"NA","This interventional, multicenter, low-intervention clinical trial aims to evaluate the usability, feasibility, safety, and preliminary clinical impact of a robotic rehabilitation system designed for upper limb rehabilitation in adults with neurological disorders, including Parkinson's disease (PD), Amyotrophic Lateral Sclerosis (ALS), post-stroke sequelae, and Mild Cognitive Impairment (MCI).\n\nThe system under study combines a collaborative robot (cobot), inertial sensors, and a graphical user interface capable of supporting reaching exercises, trajectory tracking activities, and cognitive exergames, while also enabling automatic acquisition and visualization of patient performance data.\n\nThe main questions the study aims to answer are:\n\nIs the investigational robotic rehabilitation system usable and feasible in neurological patients undergoing upper limb rehabilitation? Is the use of the device safe for both patients and healthcare operators? Does the addition of robotic-assisted rehabilitation to conventional therapy improve upper limb motor performance, cognitive function, and quality of life compared with conventional rehabilitation alone? Do movement measurements collected by the system correlate with standard clinical assessment scales?\n\nResearchers will compare conventional rehabilitation therapy plus robotic-assisted rehabilitation with conventional rehabilitation therapy alone to evaluate the impact of the device on motor, cognitive, and psychosocial outcomes.\n\nThirty participants will be randomized into two parallel treatment groups. Both groups will receive 12 sessions of conventional rehabilitation therapy lasting 60 minutes each, three times per week. Participants assigned to the experimental group will additionally receive robotic-assisted rehabilitation sessions of up to 30 minutes supervised by rehabilitation staff.\n\nParticipants will undergo:\n\nBaseline collection of demographic and clinical information; Motor, cognitive, and activities of daily living assessments using standardized clinical scales; Conventional rehabilitation therapy sessions; Robotic-assisted upper limb rehabilitation exercises, including task-oriented and trajectory-tracking activities (experimental group only); Monitoring of vital parameters and adverse events during device use; Final evaluation of usability, psychosocial impact, patient satisfaction, motor and cognitive outcomes, and safety.",[67,68,69,70],"Stroke","Amyotrophic Lateral Sclerosis","PARKINSON DISEASE (Disorder)","Mild Cognitive Impairment (MCI)",[72,73,74,75],"Collaborative Robot","Robotic rehabilitation","Neurological disorders","Graphical User Interface","NOT_YET_RECRUITING","2026-06-03",{"date":79,"type":80},"2026-06-09","ACTUAL",{"date":82,"type":61},"2026-06",{"date":84,"type":61},"2026-10",{"name":5,"class":6}]