Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT03546218
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2018-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Positive-word Stimuli on the Limits of Stability During Multi-direction Reach Operation in Standing Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-03', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-06-02', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multi-Directional Reach Test', 'timeFrame': 'Baseline and immediately after the intervention protocol', 'description': 'The limits of stability during multi-direction reach operation in standing position'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '34414832', 'type': 'DERIVED', 'citation': 'Azukizawa K, Hirose K, Morigami Y, Higashi N, Uchida H, Hirao K. Positive-word stimuli via a smartphone application have no immediate-term effects on multi-directional reach ability in standing position: a randomized controlled trial. Ann Med. 2021 Dec;53(1):1402-1409. doi: 10.1080/07853890.2021.1968483.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to examine the immediate effect of positive-word stimuli on the limits of stability during multi-direction reach operation in standing position in healthy young adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers between 18 and 24 years of age\n* Males and Females\n\nExclusion Criteria:\n\n* Person with physical disability that is enough to interfere with daily life'}, 'identificationModule': {'nctId': 'NCT03546218', 'briefTitle': 'Effect of Positive-word Stimuli on the Limits of Stability During Multi-direction Reach Operation in Standing Position', 'organization': {'class': 'OTHER', 'fullName': 'Kibi International University'}, 'officialTitle': 'Immediate Effect of Positive-word Stimuli on the Limits of Stability During Multi-direction Reach Operation in Standing Position: A Randomized Controlled Superiority Trial', 'orgStudyIdInfo': {'id': '18-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smartphone Application (SPSRS)', 'description': 'Participants watch motion picture using an application that displays positive-word stimuli.', 'interventionNames': ['Device: Smartphone Application (SPSRS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Smartphone Application (YouTube)', 'description': 'Participants will watch the same motion picture as the experimental group. However, a positive-word stimulus does not appear in the motion picture.', 'interventionNames': ['Device: Smartphone Application (YouTube)']}], 'interventions': [{'name': 'Smartphone Application (SPSRS)', 'type': 'DEVICE', 'description': 'Participants use application on iPhone and watch videos showing positive-word stimuli. This application repeats positive-word stimuli every 5 seconds.\n\nThe participants watch 3-minute motion picture displaying positive-word stimuli.', 'armGroupLabels': ['Smartphone Application (SPSRS)']}, {'name': 'Smartphone Application (YouTube)', 'type': 'DEVICE', 'description': 'Participants will watch the same motion picture as the experimental group. However, a positive-word stimulus does not appear in the motion picture.', 'armGroupLabels': ['Smartphone Application (YouTube)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Takahashi', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Kibi International University', 'geoPoint': {'lat': 34.78333, 'lon': 133.61667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kibi International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kazuki Hirao, PhD, OT', 'investigatorAffiliation': 'Kibi International University'}}}}