[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657104":3},{"organization":4,"outcomesModule":7,"designInfo":88,"detailedDescription":87,"studyPopulation":87,"armGroups":94,"interventions":101,"overallOfficials":87,"centralContacts":107,"locations":113,"responsibleParty":136,"collaborators":87,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":87,"enrollmentInfo":147,"targetDuration":87,"studyType":150,"phases":151,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":116,"whyStopped":87,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"University Hospital of Ferrara","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":46,"otherOutcomes":87},[9,13,16,19,23,26,30,33,36,40,43],{"measure":10,"description":11,"timeFrame":12},"Feasibility Outcomes: Eligibility Rate","Calculated as the ratio of eligible patients to the total number of screened patients.","Baseline",{"measure":14,"description":15,"timeFrame":12},"Feasibility Outcomes: Recruitment Rate","Calculated as the ratio of recruited patients to total eligible patients.",{"measure":17,"description":18,"timeFrame":12},"Feasibility Outcomes: Monthly Recruitment Rate","Defined as the average number of participants enrolled per month.",{"measure":20,"description":21,"timeFrame":22},"Feasibility Outcomes: Drop-out Rate","The percentage of participants who withdraw from the study.","score changes after intervention (4 weeks, T1)",{"measure":24,"description":25,"timeFrame":22},"Feasibility Outcomes: Adherence Rate","The percentage of scheduled training sessions attended",{"measure":27,"description":28,"timeFrame":29},"Feasibility Outcomes: Longitudinal Retention Rate","The percentage of enrolled participants who complete all follow-up assessments","Post-intervention follow-up assessment (3 months after intervention completion)",{"measure":31,"description":32,"timeFrame":22},"Feasibility Outcomes: Self-Reported Acceptability","Participants will complete a questionnaire at the end of the intervention to evaluate their subjective experience, perceived benefits, and difficulties of the treatment. Items are rated on a 5-point Likert scale ranging from 1 (\"low\") to 5 (\"extremely high\"), with higher scores indicating a more positive evaluation or greater perceived benefit\u002Fdifficulty.",{"measure":34,"description":35,"timeFrame":22},"Feasibility Outcomes: Adverse Events","The incidence and severity of any adverse events (e.g., falls or excessive fatigue) recorded during the study.",{"measure":37,"description":38,"timeFrame":39},"Feasibility Outcomes: Motor Exercise Intensity","The Borg Rating of Perceived Exertion (RPE) will be used to monitor and quantify physical and cognitive effort. Total score ranges from 6 to 20. Higher scores indicate greater perceived exertion","Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)",{"measure":41,"description":42,"timeFrame":39},"Feasibility Outcomes: Motor Exercise Exertion","The Borg Intensity Scale-Exerciser (BIS-E) will be used to quantify exertion. Total score ranges from 0 to 30, higher scores indicate greater perceived balance effort, difficulty, and postural instability during circuit stations.",{"measure":44,"description":45,"timeFrame":39},"Feasibility Outcomes: Digital Cognitive Progression Index (NeuronUP Activity Score)","Digital Cognitive Progression Index (NeuronUP Activity Score) will be used to quantifies session-by-session cognitive performance and adaptive difficulty progression across the 10 training sessions. The score is calculated using NeuronUP's standardized algorithm based on accuracy, total completed phases, and maximum difficulty reached, yielding a score from 0 to 100. Higher scores reflect greater task proficiency and successful progression to higher difficulty levels. This metric serves as an exploratory\u002Ffeasibility measure of intra-intervention cognitive learning.",[47,51,54,57,60,63,66,69,72,75,78,81,84],{"measure":48,"description":49,"timeFrame":50},"Motor Outcomes: Change in dynamic balance, mobility, and gait","The Timed Up and Go Test (TUG Single Task) will be used to assess the change in dynamic balance, mobility, and gait. Evaluated as time (in seconds). Lower time indicates better functional mobility.","Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)",{"measure":52,"description":53,"timeFrame":50},"Motor Outcomes: Change in Gait speed","10-Meter Walk Test (10MWT) will be used to assess change in gait speed over a 10-meter distance. Evaluated as speed in meters per second (m\u002Fs). Higher values indicate faster walking speed and improved gait dynamics.",{"measure":55,"description":56,"timeFrame":50},"Motor Outcomes: Change in Distance Walked","The 6-Minute Walk Test (6MWT) will be used to assess change in total distance walked (in meters) within 6 minutes. Evaluated as total distance walked (in meters) within 6 minutes. Higher distance indicates superior physical endurance.",{"measure":58,"description":59,"timeFrame":50},"Motor Outcomes: Change in Dynamic Balance","Mini-BESTest Total Score will be used to assess change dynamic balance abilities across four subscales (anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait).Total score ranges from 0 to 28, with higher scores indicating superior dynamic balance and lower fall risk.",{"measure":61,"description":62,"timeFrame":50},"Motor Outcomes: Change in Finger motor speed","The Finger Tapping Test Performance will be used to assess motor speed. Measures include total number of taps (right and left hand). Higher tap counts indicate better motor control.",{"measure":64,"description":65,"timeFrame":50},"Cognitive Outcomes: Change in Global cognitive function","The Montreal Cognitive Assessment (MoCA) total score will be used to assess global cognitive function. The scale ranges from 0 to 30, with higher scores indicating better global cognitive function (a score of 26 or above is generally considered normal).",{"measure":67,"description":68,"timeFrame":50},"Cognitive Outcomes: Change in Visual search and processing speed","The Trail Making Test Part A (TMT-A) will be used to assess visual search abilities and processing speed.",{"measure":70,"description":71,"timeFrame":50},"Cognitive Outcomes: Change in executive function, cognitive flexibility, and set-shifting.","The Trail Making Test Part B (TMT-B) Time will be used to assess executive function, cognitive flexibility, and set-shifting.",{"measure":73,"description":74,"timeFrame":50},"Cognitive Outcomes: Change in Information processing speed and attention","The Symbol Digit Modalities Test (SDMT) will be used to assess information processing speed and attention.",{"measure":76,"description":77,"timeFrame":50},"Cognitive Outcomes: Decision-making processing speed and cognitive-motor control","The Choice Reaction Time (CRT) Task will be used to assess decision-making processing speed and cognitive-motor control. Evaluated via number of correct responses, mean reaction time (in milliseconds) for correct responses, and mean reaction time for error responses. Lower reaction times and higher correct rates indicate better performance.",{"measure":79,"description":80,"timeFrame":50},"Cognitive Outcomes: Change in perceptive-motor speed","The Simple Reaction Time (SRT) will be used to assess reaction time speed. Evaluated as mean reaction time (in milliseconds) for correct responses and number of correct responses. Lower reaction times indicate faster processing speed; Higher correct responses indicate better accuracy.",{"measure":82,"description":83,"timeFrame":50},"Change in Quality of Life","The EQ-5D Quality of Life Questionnaire will be used to assess health-related quality of life across 5 dimensions (mobility, self-care, usual activities, pain\u002Fdiscomfort, anxiety\u002Fdepression). Higher scores indicate superior quality of life.",{"measure":85,"description":86,"timeFrame":50},"Change in Fatigue","The Parkinson Fatigue Scale (PFS-16) will be used to assess the impact of fatigue specific to Parkinson's disease. Total mean score ranges from 1 to 5. Higher scores indicate greater perceived fatigue.",null,{"allocation":89,"interventionModel":90,"interventionModelDescription":87,"primaryPurpose":91,"observationalModel":87,"timePerspective":87,"maskingInfo":92},"NA","SINGLE_GROUP","TREATMENT",{"masking":93,"maskingDescription":87,"whoMasked":87},"NONE",[95],{"label":96,"type":97,"description":98,"interventionNames":99},"Combined Motor-Cognitive Training Group","EXPERIMENTAL","Participants will receive a 10-session integrated rehabilitation program combining individual digital cognitive stimulation and group functional motor training",[100],"Behavioral: Combined group motor training and individual digital cognitive stimulation",[102],{"type":103,"name":104,"description":105,"armGroupLabels":106,"otherNames":87},"BEHAVIORAL","Combined group motor training and individual digital cognitive stimulation","Participants complete a 10-session motor-cognitive training program (3 times per week). Interventions occur on the same day in groups of 3, supervised by a neuropsychologist and physiotherapist.\n\n* Cognitive Session (30 min): Training delivered individually and tailored to baseline, individual-specific deficits using the NeuronUP application. Each session includes 5 gamified exercise types (4 minutes each) with adaptive difficulty and optional 2-minute breaks.\n* Motor Session (1 h): Group circuit of 6 stations (7 minutes for station, 2-min breaks): Stations 1-2: Cardiovascular (stepping, sit-to-stand); 3: Dynamic balance with external constraints (stepping over obstacles); 4: Dynamic balance with internal constraints (walking around obstacles); 5: Static balance exercises; 6: Functional movement transfers (Floor-to-standing)",[96],[108],{"name":109,"role":110,"phone":111,"phoneExt":87,"email":112},"Sofia Straudi, MD, PhD","CONTACT","+390532238720","sofia.straudi@unife.it",[114],{"facility":115,"status":116,"city":117,"state":118,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":128},"Ferrara University Hospital","RECRUITING","Ferrara","FE","44124","Italy","IT",{"type":123,"coordinates":124},"Point",[125,126],11.62057,44.83804,{"lat":126,"lon":125},[129,131,134],{"name":109,"role":110,"phone":130,"phoneExt":87,"email":112},"0532238720",{"name":132,"role":133,"phone":87,"phoneExt":87,"email":87},"Gaia Palma, PhD student, Psychologist","SUB_INVESTIGATOR",{"name":135,"role":133,"phone":87,"phoneExt":87,"email":87},"Andrea Baroni, Physiotherapist, PhD",{"type":137,"investigatorFullName":87,"investigatorTitle":87,"investigatorAffiliation":87,"oldNameTitle":87,"oldOrganization":87},"SPONSOR","100657104","integrated-motor-cognitive-training-in-parkinsons-disease-a-feasibility-study-100657104",false,"NCT07833748","Integrated Motor-Cognitive Training in Parkinson's Disease: A Feasibility Study","P_Feasibility","Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease\n* Presence of motor symptoms attributable to Parkinson's disease\n* Availability to participate in both treatments (cognitive and motor)\n* Severity of symptoms compatible with participation in group physical therapy\n* Absence of other medical conditions that could interfere with treatment delivery\n* Montreal Cognitive Assessment (MoCA) score \\>= 18\n* Consent to participate in group-based motor training\n* Absence of falls in the 3 months prior to baseline evaluation\n\nExclusion Criteria:\n\n* Concomitant major neurological or psychiatric disorders\n* Severe cardio-pulmonary, renal, or hepatic diseases\n* Changes in baseline pharmacological therapy within 3 months prior to enrollment","ALL","18 Years",{"count":148,"type":149},12,"ESTIMATED","INTERVENTIONAL",[89],"Parkinson's disease is a progressive neurodegenerative condition characterized by both motor symptoms (such as bradykinesia, rigidity, tremor, and postural instability) and non-motor symptoms, including cognitive impairments (affecting working memory, executive functions, and attention). Combined interventions that target both domains simultaneously or consecutively have shown potential to produce superior benefits compared to isolated motor or cognitive training.\n\nThe purpose of this study is to evaluate the feasibility, adherence, and preliminary clinical results of efficacy of an integrated and combined motor-cognitive rehabilitation training in patients diagnosed with Parkinson's disease.\n\nThis feasibility study will enroll 12 participants with Parkinson's disease. All participants will undergo a comprehensive 10-session integrated rehabilitation program combining digital cognitive individual stimulation and group functional motor training. The primary focus is to assess acceptability, safety, and adherence to this combined approach, while secondary outcomes will observe changes in relevant cognitive and motor clinical variables.",[154],"PARKINSON DISEASE (Disorder)",[156,157,158,159],"Parkinson Disease","Motor-Cognitive Training","Cognitive Rehabilitation","Motor Rehabilitation","2026-09-16",{"date":162,"type":163},"2026-09-22","ACTUAL",{"date":165,"type":163},"2026-06-01",{"date":167,"type":149},"2026-09",{"name":5,"class":6},1]