Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:40 AM
Study NCT ID:
NCT07397767
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Quantitative Parameter of Upper Extremity Function in Patients With Brain Disorder Using Smart-Board and Smart-Glove.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001927', 'term': 'Brain Diseases'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2026-01-20', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'validity', 'timeFrame': 'the day of the study procedures', 'description': 'To examine the correlation between the primary outcome measure (FM-UE) and the trunk rehabilitation assessment model derived from mobile camera, smart board, and smart glove data.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Disorder', 'Smart Device Rehabilitation']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to develop a novel quantitative metric for assessing upper-limb function in patients with neurological disorders. This will be accomplished by analyzing performance data obtained from a smart board and smart glove system and comparing these data with conventional clinical assessment methods currently used to evaluate upper-limb impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 19 years or older.\n* Patients with upper-limb functional impairment due to neurological conditions such as stroke, cerebral palsy, brain tumor, traumatic brain injury, or Parkinson's disease.\n\nExclusion Criteria:\n\n* Patients with progressive neurological disorders or those in a state of hemodynamic instability.\n* Patients with severe cognitive impairment (MMSE \\< 10) or significant communication difficulty due to language disorders.\n* Any other condition in which the investigator determines that participation in the study is inappropriate."}, 'identificationModule': {'nctId': 'NCT07397767', 'briefTitle': 'Development of Quantitative Parameter of Upper Extremity Function in Patients With Brain Disorder Using Smart-Board and Smart-Glove.', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Development of Quantitative Parameter of Upper Extremity Function in Patients With Brain Disorder Using Smart-Board and Smart-Glove, Single-Center, Prospective Study', 'orgStudyIdInfo': {'id': '2023-11-105'}, 'secondaryIdInfos': [{'id': 'RS-2023-00248118', 'type': 'OTHER_GRANT', 'domain': 'Korea Medical Device Development Fund'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smart Device User', 'description': 'Smart Device User', 'interventionNames': ['Device: smart device']}], 'interventions': [{'name': 'smart device', 'type': 'DEVICE', 'description': 'Participants will undergo two sessions of upper-limb movement assessment using the smart board and smart glove on the day of the clinical trial. Simultaneously, video recordings will be obtained using a mobile camera. These procedures will be used to collect quantitative data on upper-limb movements.', 'armGroupLabels': ['Smart Device User']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Won Hyuk Chang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}