[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625486":3},{"organization":4,"outcomesModule":7,"designInfo":84,"detailedDescription":87,"studyPopulation":87,"armGroups":93,"interventions":106,"overallOfficials":87,"centralContacts":116,"locations":122,"responsibleParty":140,"collaborators":87,"id":144,"slug":87,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":87,"eligibilityCriteria":149,"healthyVolunteers":145,"sex":150,"minAge":151,"maxAge":87,"enrollmentInfo":152,"targetDuration":87,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":170,"whyStopped":87,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"European University of Madrid","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":42},[9,13,17,20,23],{"measure":10,"description":11,"timeFrame":12},"Global Cognitive Function (Montreal Cognitive Assessment, MoCA; 0-30)","Change in MoCA total score, which assesses memory, attention, language, orientation, executive functions, and visuospatial abilities. Scores range from 0 to 30; higher scores indicate better cognitive performance.","Baseline (V0), Week 8 (V1, end of treatment), Week 16 (V2, follow-up)",{"measure":14,"description":15,"timeFrame":16},"Executive Functions (Trail Making Test, Part A and Part B; completion time in seconds)","Change in completion time for TMT-A (attention\u002Fprocessing speed) and TMT-B (set-shifting\u002Fflexibility). Lower times indicate better performance. Analyses will consider Part A and Part B separately; the B-A difference may be explored as an index of executive control.","Baseline (V0), Week 8 (V1), Week 16 (V2)",{"measure":18,"description":19,"timeFrame":16},"Gait Speed Under Single-Task Conditions (10-Meter Walk Test; meters\u002Fsecond)","Change in usual gait speed measured with the 10-Meter Walk Test.",{"measure":21,"description":22,"timeFrame":16},"Dual-Task Cost in Gait Speed (percentage)","Change in dual-task cost (DTC) in gait speed during a concurrent cognitive task (for example, serial subtraction or animal naming) versus single-task walking, calculated as:\n\nDTC(%) = \\[(single-task speed - dual-task speed) \u002F single-task speed\\] × 100. Lower percentages indicate less cognitive-motor interference and better dual-task performance.",{"measure":24,"description":25,"timeFrame":16},"Health-Related Quality of Life (EQ-5D-5L Index Score)","Change in the EuroQol EQ-5D-5L index utility score; higher values indicate better health-related quality of life. The visual analogue scale (VAS, 0-100) will be analyzed separately (see Secondary Outcomes)",[27,30,33,36,39],{"measure":28,"description":29,"timeFrame":16},"Short Physical Performance Battery (SPPB; 0-12)","Change in SPPB total score (balance, gait speed, chair stands). Higher scores reflect better lower-extremity function. Will be analyzed as continuous and ordinal.",{"measure":31,"description":32,"timeFrame":16},"Instrumental Activities of Daily Living (Lawton-Brody IADL; total score)","Change in independence for instrumental activities of daily living. Treated as a discrete quantitative variable; higher scores indicate greater autonomy.",{"measure":34,"description":35,"timeFrame":16},"Fear of Falling (Short Falls Efficacy Scale-International; total score)","Change in concern about falling during daily activities. Lower scores reflect greater confidence.",{"measure":37,"description":38,"timeFrame":16},"Mood (Geriatric Depression Scale, 15-item; total score)","Change in depressive symptoms measured with GDS-15. Treated as a discrete quantitative variable; lower scores indicate fewer symptoms.",{"measure":40,"description":41,"timeFrame":16},"Functional Strength (Five Times Sit-to-Stand; seconds)","Change in time to complete five chair rises without using the arms. Lower times indicate better functional lower-limb strength.",[43,47,50,53,57,61,65,69,73,77,81],{"measure":44,"description":45,"timeFrame":46},"Program Adherence (percent of planned sessions completed)","Percentage of completed sessions out of 24 planned sessions (3\u002Fweek × 8 weeks). Adequate adherence defined as ≥80%.","During the 8-week intervention; summarized again at Week 16 (V2)",{"measure":48,"description":49,"timeFrame":46},"Effective Practice Dose (minutes of active task execution per session and in total)","Clinician-timed minutes of active motor or cognitive task execution across sessions.",{"measure":51,"description":52,"timeFrame":46},"Postural Accuracy","Number of correctly executed tasks per session",{"measure":54,"description":55,"timeFrame":56},"Perceived Exertion (Modified Borg Scale; 0-10)","Session-level rating of perceived exertion; higher values indicate greater perceived effort.","End of each training session; summarized at Week 8 and Week 16",{"measure":58,"description":59,"timeFrame":60},"Professional Workload (minutes per session)","Clinician time devoted to preparation, supervision, and documentation.","During the 8-week intervention; summarized at Week 16 (V2)",{"measure":62,"description":63,"timeFrame":64},"Usability (System Usability Scale; 0-100)","Usability measured with the System Usability Scale.","Week 8 (V1) and Week 16 (V2)",{"measure":66,"description":67,"timeFrame":68},"Direct cost per particiapnt (euros)","Direct costs per participant (professional time, materials, technical support) related to observed improvements in quality of life (EQ-5D-5L)","Baseline to Week 16 (V2)",{"measure":70,"description":71,"timeFrame":72},"Compensatory Movements","number of observed compensations per session",": During 8 week intervention; summarized again at Week 16",{"measure":74,"description":75,"timeFrame":76},"Participant Satisfaction","5 point Likert rating","Week 8 and Week 16",{"measure":78,"description":79,"timeFrame":80},"Cost Effectiveness (Incremental Cost Effectiveness Ratio)","cost per unit of improvement","Baseline to Week 16",{"measure":82,"description":83,"timeFrame":80},"Functional Autonomy (Lawton-Brody Scale)","total score (0-8)",{"allocation":85,"interventionModel":86,"interventionModelDescription":87,"primaryPurpose":88,"observationalModel":87,"timePerspective":87,"maskingInfo":89},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":90,"maskingDescription":87,"whoMasked":91},"SINGLE",[92],"OUTCOMES_ASSESSOR",[94,100],{"label":95,"type":96,"description":97,"interventionNames":98},"Experimental - Exergame-Based Digital Neurorehabilitation","EXPERIMENTAL","Participants will complete a structured digital neurorehabilitation program using a CE-marked telerehabilitation platform that delivers lower-limb and balance training through therapeutic video games (exergames). The program integrates motor and cognitive tasks to promote functional mobility, balance, and dual-task performance. Training is semi-autonomous, with remote monitoring and real-time feedback.",[99],"Behavioral: Digital exergame-based neurorehabilitation program",{"label":101,"type":102,"description":103,"interventionNames":104},"Active Comparator - Conventional Physiotherapy","ACTIVE_COMPARATOR","Participants will receive a standard individual physiotherapy program focused on lower-limb strengthening, balance training, and gait exercises. The duration and weekly frequency will be equivalent to the intervention group.",[105],"Behavioral: Individual conventional physiotherapy",[107,112],{"type":108,"name":109,"description":110,"armGroupLabels":111,"otherNames":87},"BEHAVIORAL","Digital exergame-based neurorehabilitation program","Participants will perform interactive exergame-based exercises targeting lower-limb strength, balance, postural control, and cognitive-motor interaction. Exercises progressively increase in difficulty and incorporate tasks that require simultaneous physical movement and cognitive processing (dual-task training).\n\nIntervention Dose:\n\nThree sessions per week for eight weeks. Each session lasts 30-40 minutes.\n\nFollow-Up:\n\nOutcome assessments at baseline (V0), week 8 (V8), and week 16 (V16) to examine maintenance of benefits.",[95],{"type":108,"name":113,"description":114,"armGroupLabels":115,"otherNames":87},"Individual conventional physiotherapy","Sessions include traditional balance exercises, strength training for the lower limbs, gait practice, and functional mobility activities conducted by a physiotherapist.\n\nIntervention Dose:\n\nThree sessions per week for eight weeks. Session duration is equivalent to the experimental group.\n\nFollow-Up:\n\nOutcome assessments at baseline (V0), week 8 (V8), and week 16 (V16).",[101],[117],{"name":118,"role":119,"phone":120,"phoneExt":87,"email":121},"Marina Castel-Sánchez, PhD","CONTACT","+34679448994","marina.castel@universidadeuropea.es",[123],{"facility":124,"status":87,"city":125,"state":126,"zip":127,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":135,"contacts":136},"Universidad Europea de Madrid","Villaviciosa de Odón","Madrid","28760","Spain","ES",{"type":131,"coordinates":132},"Point",[133,134],-3.9043,40.3581,{"lat":134,"lon":133},[137],{"name":118,"role":119,"phone":138,"phoneExt":87,"email":139},"0034+679448994","marina_spa@hotmail.it",{"type":141,"investigatorFullName":142,"investigatorTitle":143,"investigatorAffiliation":5,"oldNameTitle":87,"oldOrganization":87},"PRINCIPAL_INVESTIGATOR","Marina Castel Sánchez","Associate Professor","100625486",false,"NCT07423260","Evaluation of a Digital Neurorehabilitation Program Using Exergames for Adults With Mild Cognitive Impairment","Digital Exergame Neurorehabilitation to Enhance Quality of Life and Functional Autonomy in Institutionalized Older Adults With Mild Cognitive Impairment: Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 70 years or older.\n* Diagnosis of mild cognitive impairment, defined by Montreal Cognitive Assessment (MoCA) score between 18 and 25.\n* Ability to maintain standing and\u002For ambulate with or without assistive devices.\n* Institutional residence for at least 3 months.\n* Informed consent provided by participant or legal representative.\n\nExclusion Criteria:\n\n* Acute illness, musculoskeletal condition, or pain that limits safe participation in training.\n* Uncompensated sensory deficits (vision or hearing) that interfere with task performance.\n* Disruptive behavior or neuropsychiatric symptoms that impede participation.\n* Active epilepsy or medical contraindications for physical exercise.","ALL","70 Years",{"count":153,"type":154},38,"ESTIMATED","INTERVENTIONAL",[157],"NA","The goal of this clinical trial is to learn whether a semi-autonomous digital telerehabilitation program using therapeutic video games (\"exergames\") can help improve quality of life and functional independence in older adults living in long-term care centers who have mild cognitive impairment (MCI).\n\nThe main questions we want to answer are:\n\nDoes this exergame-based program help participants move better, walk more safely, and perform daily activities with more independence? Does it improve confidence while moving and lower the fear of falling? Is this program cost-effective compared with a standard one-to-one physiotherapy program?\n\nResearchers will compare two groups:\n\nIntervention group: participants will use a CE-marked digital rehabilitation platform that provides lower-limb and balance training through interactive exergames.\n\nControl group: participants will receive an individual physiotherapy program of similar duration and intensity.\n\nParticipants will:\n\nTake part in a 6-week training program (using exergames or standard physiotherapy, depending on their group).\n\nComplete tests that measure mobility, balance, walking while doing a cognitive task (called \"dual task\"), confidence in avoiding falls, and daily functioning.\n\nAnswer short questionnaires about well-being and quality of life.\n\nThis pilot study will help determine whether the exergame-based program is safe, useful, and feasible for older adults with MCI living in long-term care settings.",[160],"Mild Cognitive Impairment",[162,163,164,165,166,167,168,169],"mild cognitive impairment","older adults","digital neurorehabilitation","Telerehabilitation","Therapeutic video games","Exergames","Gait and dual-task performance","Balance training","NOT_YET_RECRUITING","2026-02-17",{"date":173,"type":174},"2026-02-20","ACTUAL",{"date":176,"type":154},"2026-03",{"date":178,"type":154},"2026-10",{"name":5,"class":6},1]