Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-02-09 @ 9:41 PM
Study NCT ID:
NCT03779958
Status:
WITHDRAWN
Last Update Posted:
2021-08-06
First Post:
2018-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alternatives to Hand Therapy for Hand Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D052582', 'term': 'Trigger Finger Disorder'}, {'id': 'D045888', 'term': 'Ganglion Cysts'}, {'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D053682', 'term': 'Tendon Entrapment'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D017520', 'term': 'Mucinoses'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Logistics (Research Staffing)', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-30', 'studyFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2018-12-17', 'lastUpdatePostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QuickDASH', 'timeFrame': 'once a week for 6 weeks', 'description': 'The QD is a short form of the DASH, which measures disability of the arm, shoulder and hand. it is scored 0-100, with higher scores indicating higher disability'}], 'secondaryOutcomes': [{'measure': 'Patient Specific Functional Scale', 'timeFrame': 'once a week for 6 weeks', 'description': 'the PSFS is a validated measure of disability, that is scored on a 0-10 scale with lower scored indicating higher disability.'}, {'measure': 'VAS Pain', 'timeFrame': 'once a week for 6 weeks', 'description': 'VAS pain is a validated measure of pain, scored 0-10, with higher scores indicating higher pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome', 'Trigger Finger', 'Ganglion Cysts', 'Distal Radius Fracture', 'Finger Fracture', 'De Quervain Syndrome']}, 'descriptionModule': {'briefSummary': 'Patients will be asked to use a mobile phone app to conduct their hand therapy after having hand surgery.', 'detailedDescription': 'Patients who are undergoing the included procedures will be informed of the study \\& consented. They will be given information on how to download the app \\& input their surgery date. The app will guide the patient through various hand therapy exercises and ask them to record their QuickDASH, PSFS and VAS Pain weekly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients presenting to a single hand surgery clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing the following procedures: carpal tunnel release, trigger finger release, distal radius fracture fixation, de quervains release, cyst excision, finger fracture fixation\n* smart phone that is compatible with the app\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03779958', 'briefTitle': 'Alternatives to Hand Therapy for Hand Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Alternatives to Hand Therapy for Hand Surgery Patients', 'orgStudyIdInfo': {'id': '47777'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group', 'description': 'All patients will be given information about a mobile app to use during the recovery period to assist with hand therapy activities', 'interventionNames': ['Other: Mobile App']}], 'interventions': [{'name': 'Mobile App', 'type': 'OTHER', 'description': 'a mobile app that demonstrates hand therapy exercises', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Health Care', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}], 'overallOfficials': [{'name': 'Robin N Kamal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Robin Kamal', 'investigatorAffiliation': 'Stanford University'}}}}