Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:48 AM
Study NCT ID:
NCT07442461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Assistance for Daily Living: Neurophysiological and Functional Effects in Low Vision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Localization Accuracy Percentage', 'timeFrame': 'Baseline', 'description': 'Phase I only. Successful location accuracy defined as percentage of attempts with localization accuracy within 1 meter.'}, {'measure': 'Orientation Precision Percentage', 'timeFrame': 'Baseline', 'description': 'Phase I only. Successful location accuracy defined as percentage of attempts with orientation precision within 5 degrees.'}, {'measure': 'Percentage of Tasks Successfully Completed', 'timeFrame': 'Baseline', 'description': 'Phase I only.'}, {'measure': 'Object/Hazard Detection Error Rate', 'timeFrame': 'Baseline', 'description': 'Phase I only. Object/hazard detection error rate measured during navigation tasks.'}, {'measure': 'Average Time to Complete Activities of Daily Living (ADLs)', 'timeFrame': 'Baseline', 'description': 'Phase I only.'}, {'measure': 'Change from Baseline in Moderate-Equivalent Minutes of Physical Activity Per Week', 'timeFrame': 'Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)', 'description': 'Phase II only. Data captured via wearable sensors and the International Physical Activity Questionnaire (IPAQ).'}, {'measure': 'Change from Baseline in Average Daily Step Count', 'timeFrame': 'Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)', 'description': 'Phase II only.'}, {'measure': 'Change from Baseline in Blood Pressure', 'timeFrame': 'Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12', 'description': 'Phase II only.'}, {'measure': 'Change from Baseline in Resting Heart Rate', 'timeFrame': 'Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12', 'description': 'Phase II only.'}, {'measure': 'Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12', 'description': 'Phase II only.'}], 'secondaryOutcomes': [{'measure': 'System Usability Scale (SUS) Score', 'timeFrame': 'End of Intervention Period (Month 6 for Group A; Month 12 for Group B)', 'description': 'Phase II only. 10-item assessment evaluating usability of a system. Each item is rated on a Likert scale from 1-5. The raw score is the sum of responses and is transformed to a standardized score from 0-100; higher scores indicate greater satisfaction.'}, {'measure': 'Change in WHO Quality of Life Brief Instrument (WHO-QoL-BREF) Score', 'timeFrame': 'Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)', 'description': 'Phase II only. WHO-QoL-BREF is a 26-item questionnaire assessing quality of life. Each item is rated on a 5-point Likert scale to determine a raw item score. The mean score for each six domains of the questionnaire is calculated, resulting in a mean score per domain that is between 4 and 20. This mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score ranging from 16-80, with a higher score indicating a higher QOL.'}, {'measure': 'Change in National Eye Institute Visual Function Questionnaire (VFQ-25) Score', 'timeFrame': 'Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)', 'description': 'Phase II only. The VFQ-25 is a 25-item assessment of visual function. Each item is rated on a scale from 0-4; the total score is the sum of responses and ranges from 0-100; higher scores indicate greater vision function and vision quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Visual Impairment']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate how visual impairment affects neurophysiological and biomechanical responses during real-world navigation and daily activities, with a focus on the rehabilitative feasibility and impact of assistive technologies. These technologies include applications and wearable devices designed to support various aspects of daily living for individuals with visual impairment. The VIS4ION platform (Visually Impaired Smart Service System for Spatial Intelligence \\& On-board Navigation), a wearable system providing tactile and auditory feedback, is one component of this broader study. VIS4ION is designed to enhance environmental awareness and reduce cognitive load during mobility tasks for the visually impaired.', 'detailedDescription': "Participants with low vision and matched controls will complete walking, navigation, information gathering, and object identification / reaching tasks in both controlled laboratory and real-world environments. Throughout these tasks, physiological measures (e.g., electrodermal activity, heart rate, brain activity, eye movements), biomechanical data (e.g., gait, posture, limb movements), and cognitive metrics will be collected. VIS4ION will be specifically evaluated for its potential to improve the low vision users' scene understanding, navigation efficiency, increase physical activity (e.g., step count, moderate-equivalent minutes), and contribute to improved outcomes in terms of health, awareness, cognitive load, and safety.\n\nStudy tasks include obstacle negotiation, dual-task walking, and object identification / reaching under varying conditions (indoor vs. outdoor; with vs. without VIS4ION). A subset of participants will use VIS4ION over extended periods to assess its impact on activities in daily life in real-world settings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPeople with Visual Impairment:\n\n* Age between 18 and 80 years.\n* Diagnosis of visual impairment (any level, any etiology).\n* Current use of a primary mobility assistive device (e.g., white cane or guide dog).\n* Ability to travel independently (without assistance from another person).\n* Capacity to provide informed consent.\n* Willingness to complete all study-related assessments and procedures\n\nHealthy Controls:\n\n* Age between 18 and 80 years.\n* No self-reported visual impairment or use of mobility assistive devices.\n* Capacity to provide informed consent.\n* Willingness to complete all study-related assessments and procedures.\n\nExclusion Criteria:\n\n* Significant cognitive dysfunction (score \\<24 on Folsteins' Mini Mental Status Examination)\n* Previous neurological illness, complicated medical condition (inclusive of comorbid cognitive impairment)\n* Significant mobility restrictions; people using walkers and wheelchairs\n* Pregnancy\n* Profound auditory impairments (i.e., cannot understand human speech)\n* Somatosensory impairments to the trunk or torso that precludes use of the haptic interfaces\n* Significant depression (score \\> 11 on the Geriatric Depression scale)"}, 'identificationModule': {'nctId': 'NCT07442461', 'briefTitle': 'Virtual Assistance for Daily Living: Neurophysiological and Functional Effects in Low Vision', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Effects of Visual Impairment on Neurophysiological Responses and the Feasibility and Impact of Multimodal Virtual Assistance for Instrumental Activities of Daily Living in Low Vision Populations', 'orgStudyIdInfo': {'id': '25-00717'}, 'secondaryIdInfos': [{'id': 'R01EY037505', 'link': 'https://reporter.nih.gov/quickSearch/R01EY037505', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Technical Evaluation Group', 'description': "Participants, both sighted-blindfolded and people with blindness or low vision, will complete simple navigation, object-identification, and object-reaching tasks, both with and without VIS4ION's services.", 'interventionNames': ['Device: VIS4ION Platform']}, {'type': 'EXPERIMENTAL', 'label': 'Extended Use Trial: Group A', 'description': 'Participants with blindness or low vision will complete navigation and object-identification tasks with the device during months 1-6, then without the device during months 6-12.', 'interventionNames': ['Device: VIS4ION Platform']}, {'type': 'EXPERIMENTAL', 'label': 'Extended Use Trial: Group B', 'description': 'Participants with blindness or low vision will complete navigation and object-identification tasks without the device during months 1-6, then with the device during months 6-12.', 'interventionNames': ['Device: VIS4ION Platform']}], 'interventions': [{'name': 'VIS4ION Platform', 'type': 'DEVICE', 'description': 'The VIS4ION platform, a non-invasive wearable and smartphone-based system providing auditory (bone-conduction headphones) and haptic (wristband/belt) feedback to enhance mobility and daily living for people with blindness or low vision.', 'armGroupLabels': ['Extended Use Trial: Group A', 'Extended Use Trial: Group B', 'Technical Evaluation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Mahya Beheshti', 'role': 'CONTACT', 'email': 'Mahya.beheshti@nyulangone.org', 'phone': '646-501-9189'}, {'name': 'Giles Hamilton-Fletcher', 'role': 'CONTACT', 'email': 'Giles.hamilton-fletcher@nyulangone.org', 'phone': '646-906-6008'}], 'overallOfficials': [{'name': 'John-Ross Rizzo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': "The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Mahya.beheshti@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.", 'accessCriteria': "The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Mahya.beheshti@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}