Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-03-17 @ 10:24 PM
Study NCT ID:
NCT06290167
Status:
RECRUITING
Last Update Posted:
2025-08-04
First Post:
2023-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2023-10-06', 'studyFirstSubmitQcDate': '2024-03-01', 'lastUpdatePostDateStruct': {'date': '2025-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive functions', 'timeFrame': 'Immediately after the training experience', 'description': 'Improvement in cognitive functioning assessed with a complete neuropsychological battery focused on different domains such as executive function, memory, and attention.'}, {'measure': 'Motor functions', 'timeFrame': 'Immediately after the training experience', 'description': 'Improvement in motor functioning assessed with specific test focused on balance, functional mobility, and walking speed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Decline']}, 'descriptionModule': {'briefSummary': 'The main objective of this project is two-fold\n\n1. to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity\n2. to investigate its efficacy in improving the cognitive functioning in a randomized clinical trial for 2 different populations: subjects with subjective memory complaints and mild cognitive impairment.\n\nSpecifically, participants will follow an integrated training including 2 phases: 1)in-hospital rehabilitation, where subjects will be provided sessions of the training in immersive modality; 2)at-home rehabilitation, where older adults will be asked to perform at home the non-immersive version of the training using a tablet.\n\nExpected outcome is an improvement in cognitive functioning (assessed with a complete neuropsychological battery) after the training, thus advancing literature about non-pharmacological interventions in the preclinical stages of dementia along with innovative technical instruments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (group of SMC):\n\n* \\> 65 years old\n* self-reported memory complaints\n* score on Mini-Mental State Examination greater than or equal to 27/30 (normal range)\n\nExclusion Criteria:\n\n* no evidence of objective impairments on the neuropsychological testing, scores on the Clinical Dementia Rating \\< 0.5\n\nInclusion Criteria (group of MCI):\n\n* \\> 65 years old\n* a self-reported (or reported by a caregiver) cognitive decline\n* an objective impairment on the neuropsychological testing\n* scores on the Clinical Dementia Rating \\< 0.5.\n\nExclusion Criteria:\n\n* no dementia'}, 'identificationModule': {'nctId': 'NCT06290167', 'acronym': 'DUAL-Rehab', 'briefTitle': 'A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab', 'orgStudyIdInfo': {'id': '30M201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '360° media', 'description': 'All participants will be randomly assigned to 360° media or TAU condition', 'interventionNames': ['Device: 360° media']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment As Usual (TAU)', 'description': 'All participants will be randomly assigned to TAU or 360° media condition', 'interventionNames': ['Other: Treatment As Usual (TAU)']}, {'type': 'OTHER', 'label': 'In hospital sessions', 'description': 'all participants will perform session in hospital', 'interventionNames': ['Other: In hospital sessions']}, {'type': 'OTHER', 'label': 'at home sessions', 'description': 'all participants will perform session at home', 'interventionNames': ['Other: at home sessions']}, {'type': 'OTHER', 'label': 'Mild Cognitive Impairment', 'description': 'half of the patients will have MCI', 'interventionNames': ['Other: Mild Cognitive Impairment']}, {'type': 'OTHER', 'label': 'Subjective Memory Complain', 'description': 'half of the patients will have SMC', 'interventionNames': ['Other: Subjective Memory Complain']}], 'interventions': [{'name': '360° media', 'type': 'DEVICE', 'description': 'sessions with head mounted display in hospital and sessions with tablet at home', 'armGroupLabels': ['360° media']}, {'name': 'Treatment As Usual (TAU)', 'type': 'OTHER', 'description': 'sessions of TAU rehabilitation in hospital and sessions TAU rehabilitation at home', 'armGroupLabels': ['Treatment As Usual (TAU)']}, {'name': 'In hospital sessions', 'type': 'OTHER', 'description': 'sessions will be carried out under the supervision of a therapist', 'armGroupLabels': ['In hospital sessions']}, {'name': 'at home sessions', 'type': 'OTHER', 'description': 'sessions will be carried out without the supervision of a therapist', 'armGroupLabels': ['at home sessions']}, {'name': 'Mild Cognitive Impairment', 'type': 'OTHER', 'description': 'half of this group will perform the protocol with 360° videos and the other half will perform the TAU', 'armGroupLabels': ['Mild Cognitive Impairment']}, {'name': 'Subjective Memory Complain', 'type': 'OTHER', 'description': 'half of this group will perform the protocol with 360° videos and the other half will perform the TAU', 'armGroupLabels': ['Subjective Memory Complain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20149', 'city': 'Milan', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elisa Pedroli, PsyD', 'role': 'CONTACT', 'email': 'e.pedroli@auxologico.it', 'phone': '02 61911 2707'}], 'facility': 'Istituto Auxologico Italiano IRCCS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Elisa Pedroli, PsyD', 'role': 'CONTACT', 'email': 'e.pedroli@auxologico.it', 'phone': '02 61911 2707'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}