[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurocognitive-impairment-mild\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurocognitive-impairment-mild":52},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100524738",false,"NCT06112639","The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders","DANCE REhabilitation Experience (DANCEREX-DTx): Protocol for a Randomized Controlled Trial on Effectiveness of Digital Therapeutics in Chronic Neurological Disabilities","DANCEREX-DTx","Inclusion Criteria:\n\n1. age between 18 and 85 years (adult and older adult);\n2. education equal to or more than five years\n3. agreement to participate with the signature of the informed consent form;\n4. clinical diagnosis of Multiple Sclerosis (MS) according to the 2017 revised criteria of MC Donald - Expanded Disability Status Scale (EDSS) score equal or less than 4.5, R-R disease course, freedom from relapses, and steroid treatment for at least one month, OR clinical diagnosis of pre-Mild Cognitive Impairment - MCI (Subjective Memory Complaints and\u002For Subjective Cognitive Complaints)\u002FMCI at risk of Alzheimer's Disease with the Clinical Dementia Rating (CDR) scale equal or less than 0.5\n5. Normal score to a screening test for cognitive impairment (Montreal Cognitive Assessment test - MoCA test \\> 15.5 Santangelo et al., 2015)\n\nExclusion Criteria:\n\n1. presence of comorbidities that prevent patients from undertaking a safe home program (e.g., balance problems, history of falls in the past 6 months, use of assistive devices for deambulation)\n2. presence of overt hearing\u002Fvisual impairment\n3. for the MCI group, the absence of a caregiver\u002Fstudy partner able to support the participant;\n4. no living in one's own home;\n5. for the MS group, score in cerebellum function at EDSS greater than 3","ALL","18 Years","85 Years",{"count":20,"type":21},192,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to test a new digital therapeutic solution which combines a holistic, multidimensional rehabilitation program based on dance and music with an innovative motivational system (DANCEREX-DTx) in Chronic Neurological Disorders (Multiple Sclerosis and pre-Mild Cognitive Impairment - MCI\u002F MCI at risk of Alzheimer's Disease). The main questions it aims to answer are 1\\] efficacy of the digital therapeutic solution in terms of adherence, clinical\u002Ffunctional measures, quality of life and surrogate measures; 2\\] usability and acceptability of the system.\n\nParticipants will be randomized (with an allocation ratio of 2:2:1) into the experimental group (DANCEREX - 24 sessions of multidimensional dance-based program integrated with an innovative motivational system), active comparator group (24 sessions of multidimensional dance-based program) and placebo group (24 sessions of educational program). Researchers will compare the experimental group to the other two groups to see if a digital therapeutic solution integrating a multidimensional dance-based program and motivational system is effective in increasing adherence to rehabilitation treatment.",[27,28,29],"Sclerosis, Multiple","Neurocognitive Impairment, Mild","Neurocognitive Dysfunction",[31,32,33,34,35,36,37,38],"rehabilitation","multiple sclerosis","dementia","digital therapeutics","neurocognitive dysfunction","MRI","neuroinflammation","telerehabilitation","RECRUITING","2025-01-09",{"date":42,"type":43},"2025-01-10","ACTUAL",{"date":45,"type":43},"2024-01-31",{"date":47,"type":21},"2025-10-31",{"name":49,"class":50},"Fondazione Don Carlo Gnocchi Onlus","OTHER",3,""]