Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:22 AM
Study NCT ID:
NCT07423260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Digital Neurorehabilitation Program Using Exergames for Adults With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Program Adherence (percent of planned sessions completed)', 'timeFrame': 'During the 8-week intervention; summarized again at Week 16 (V2)', 'description': 'Percentage of completed sessions out of 24 planned sessions (3/week × 8 weeks). Adequate adherence defined as ≥80%.'}, {'measure': 'Effective Practice Dose (minutes of active task execution per session and in total)', 'timeFrame': 'During the 8-week intervention; summarized again at Week 16 (V2)', 'description': 'Clinician-timed minutes of active motor or cognitive task execution across sessions.'}, {'measure': 'Postural Accuracy', 'timeFrame': 'During the 8-week intervention; summarized again at Week 16 (V2)', 'description': 'Number of correctly executed tasks per session'}, {'measure': 'Perceived Exertion (Modified Borg Scale; 0-10)', 'timeFrame': 'End of each training session; summarized at Week 8 and Week 16', 'description': 'Session-level rating of perceived exertion; higher values indicate greater perceived effort.'}, {'measure': 'Professional Workload (minutes per session)', 'timeFrame': 'During the 8-week intervention; summarized at Week 16 (V2)', 'description': 'Clinician time devoted to preparation, supervision, and documentation.'}, {'measure': 'Usability (System Usability Scale; 0-100)', 'timeFrame': 'Week 8 (V1) and Week 16 (V2)', 'description': 'Usability measured with the System Usability Scale.'}, {'measure': 'Direct cost per particiapnt (euros)', 'timeFrame': 'Baseline to Week 16 (V2)', 'description': 'Direct costs per participant (professional time, materials, technical support) related to observed improvements in quality of life (EQ-5D-5L)'}, {'measure': 'Compensatory Movements', 'timeFrame': ': During 8 week intervention; summarized again at Week 16', 'description': 'number of observed compensations per session'}, {'measure': 'Participant Satisfaction', 'timeFrame': 'Week 8 and Week 16', 'description': '5 point Likert rating'}, {'measure': 'Cost Effectiveness (Incremental Cost Effectiveness Ratio)', 'timeFrame': 'Baseline to Week 16', 'description': 'cost per unit of improvement'}, {'measure': 'Functional Autonomy (Lawton-Brody Scale)', 'timeFrame': 'Baseline to Week 16', 'description': 'total score (0-8)'}], 'primaryOutcomes': [{'measure': 'Global Cognitive Function (Montreal Cognitive Assessment, MoCA; 0-30)', 'timeFrame': 'Baseline (V0), Week 8 (V1, end of treatment), Week 16 (V2, follow-up)', 'description': '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.'}, {'measure': 'Executive Functions (Trail Making Test, Part A and Part B; completion time in seconds)', 'timeFrame': 'Baseline (V0), Week 8 (V1), Week 16 (V2)', 'description': 'Change in completion time for TMT-A (attention/processing speed) and TMT-B (set-shifting/flexibility). 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.'}, {'measure': 'Gait Speed Under Single-Task Conditions (10-Meter Walk Test; meters/second)', 'timeFrame': 'Baseline (V0), Week 8 (V1), Week 16 (V2)', 'description': 'Change in usual gait speed measured with the 10-Meter Walk Test.'}, {'measure': 'Dual-Task Cost in Gait Speed (percentage)', 'timeFrame': 'Baseline (V0), Week 8 (V1), Week 16 (V2)', 'description': '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) / single-task speed\\] × 100. Lower percentages indicate less cognitive-motor interference and better dual-task performance.'}, {'measure': 'Health-Related Quality of Life (EQ-5D-5L Index Score)', 'timeFrame': 'Baseline (V0), Week 8 (V1), Week 16 (V2)', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Short Physical Performance Battery (SPPB; 0-12)', 'timeFrame': 'Baseline (V0), Week 8 (V1), Week 16 (V2)', 'description': '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': 'Instrumental Activities of Daily Living (Lawton-Brody IADL; total score)', 'timeFrame': 'Baseline (V0), Week 8 (V1), Week 16 (V2)', 'description': 'Change in independence for instrumental activities of daily living. Treated as a discrete quantitative variable; higher scores indicate greater autonomy.'}, {'measure': 'Fear of Falling (Short Falls Efficacy Scale-International; total score)', 'timeFrame': 'Baseline (V0), Week 8 (V1), Week 16 (V2)', 'description': 'Change in concern about falling during daily activities. Lower scores reflect greater confidence.'}, {'measure': 'Mood (Geriatric Depression Scale, 15-item; total score)', 'timeFrame': 'Baseline (V0), Week 8 (V1), Week 16 (V2)', 'description': 'Change in depressive symptoms measured with GDS-15. Treated as a discrete quantitative variable; lower scores indicate fewer symptoms.'}, {'measure': 'Functional Strength (Five Times Sit-to-Stand; seconds)', 'timeFrame': 'Baseline (V0), Week 8 (V1), Week 16 (V2)', 'description': 'Change in time to complete five chair rises without using the arms. Lower times indicate better functional lower-limb strength.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mild cognitive impairment', 'older adults', 'digital neurorehabilitation', 'Telerehabilitation', 'Therapeutic video games', 'Exergames', 'Gait and dual-task performance', 'Balance training'], 'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/or 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.'}, 'identificationModule': {'nctId': 'NCT07423260', 'briefTitle': 'Evaluation of a Digital Neurorehabilitation Program Using Exergames for Adults With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'European University of Madrid'}, 'officialTitle': 'Digital Exergame Neurorehabilitation to Enhance Quality of Life and Functional Autonomy in Institutionalized Older Adults With Mild Cognitive Impairment: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NEUROREAVIRTDCL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental - Exergame-Based Digital Neurorehabilitation', 'description': '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.', 'interventionNames': ['Behavioral: Digital exergame-based neurorehabilitation program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator - Conventional Physiotherapy', 'description': '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.', 'interventionNames': ['Behavioral: Individual conventional physiotherapy']}], 'interventions': [{'name': 'Digital exergame-based neurorehabilitation program', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Experimental - Exergame-Based Digital Neurorehabilitation']}, {'name': 'Individual conventional physiotherapy', 'type': 'BEHAVIORAL', 'description': '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).', 'armGroupLabels': ['Active Comparator - Conventional Physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28760', 'city': 'Villaviciosa de Odón', 'state': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Marina Castel-Sánchez, PhD', 'role': 'CONTACT', 'email': 'marina_spa@hotmail.it', 'phone': '0034+679448994'}], 'facility': 'Universidad Europea de Madrid', 'geoPoint': {'lat': 40.3581, 'lon': -3.9043}}], 'centralContacts': [{'name': 'Marina Castel-Sánchez, PhD', 'role': 'CONTACT', 'email': 'marina.castel@universidadeuropea.es', 'phone': '+34679448994'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to privacy considerations and institutional regulations regarding access to sensitive health information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European University of Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marina Castel Sánchez', 'investigatorAffiliation': 'European University of Madrid'}}}}