Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT04196218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-19
First Post:
2019-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Driving After Shoulder Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2019-12-09', 'studyFirstSubmitQcDate': '2019-12-11', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Driving Assessment', 'timeFrame': 'surgery through 12 weeks post-op', 'description': 'Clinical Driving Simulator'}], 'secondaryOutcomes': [{'measure': 'Range of Motion', 'timeFrame': 'surgery through 12 weeks post-op', 'description': 'Measuring shoulder range of motion'}, {'measure': 'Strength', 'timeFrame': 'surgery through 12 weeks post-op', 'description': 'Measuring shoulder strength'}, {'measure': 'Visual Analog Pain Score', 'timeFrame': 'surgery through 12 weeks post-op', 'description': 'Patient reported level of pain on a scale of 0 to 10, with 10 being extreme pain and 0 being no pain'}, {'measure': 'Single Alpha Numeric Evaluation of the shoulder', 'timeFrame': 'surgery through 12 weeks post-op', 'description': 'Percentage of normal for affected shoulder between 0 and 100, with 100 being a perfectly "normal" shoulder and 0 being a completely "abnormal" shoulder'}, {'measure': 'Veterans Rand 12 Item Health Survey', 'timeFrame': 'surgery through 12 weeks post-op', 'description': 'Patient reported quality of life. Score contains a physical component and mental component score. Both scales are continuous and values range from 0 to 70, with higher scoring indicating higher physical and mental component scores'}, {'measure': 'Brief Resilience Scale', 'timeFrame': 'surgery through 12 weeks post-op', 'description': 'Patient reported resilience on a scale of 0 to 30, with 30 indicating high resilience and 0 indicating low resilience'}, {'measure': 'Shoulder function', 'timeFrame': 'surgery through 12 weeks post-op', 'description': 'Shoulder function as measured by American Shoulder and Elbow Surgeons assessment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder']}, 'descriptionModule': {'briefSummary': 'Patients undergoing a shoulder arthroplasty or rotator cuff repair will be enrolled in the study. Patients will be asked to undergo driving simulator assessments post-operatively in ATI Physical Therapy for up to 12 weeks after surgery in order to determine when it may be safe for them to return to driving. Additional assessments include patient-reported outcomes, range of motion, and strength measures, which are all standard of care. Study participation concludes when the patient passes the driving simulator test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing either Rotator Cuff Repair or Shoulder arthroplasty from participating surgeon\n2. Patients receiving physical therapy from ATI Patewood clinic\n3. Must be able and willing to complete all study assessments and to be followed for the full course of the study.\n4. Must be able to read, write and follow instructions in English.\n5. In the opinion of the investigator, is that they subject is competent to participate in study activities\n6. Prior to injury, patient was routinely driving.\n\nExclusion Criteria:\n\n1. Prior shoulder surgery in the last 90 day\n2. Individuals with a history of any underlying neurological conditions'}, 'identificationModule': {'nctId': 'NCT04196218', 'briefTitle': 'Driving After Shoulder Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Hawkins Foundation'}, 'officialTitle': 'Driving After Arthroscopic Rotator Cuff Repair or Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': 'Pro00095486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Driving assessment', 'description': 'All subjects will undergo a driving assessment(s) following shoulder surgery.', 'interventionNames': ['Other: Driving simulator']}], 'interventions': [{'name': 'Driving simulator', 'type': 'OTHER', 'description': 'Computer simulated driving assessment', 'armGroupLabels': ['Driving assessment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Stephan Pill, MD', 'role': 'CONTACT', 'email': 'stephan.pill@prismahealth.org', 'phone': '864 454-7394'}, {'name': 'Kyle J Adams', 'role': 'CONTACT', 'email': 'kyle.adams@hawkinsfoundation.com', 'phone': '864 454 7458'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hawkins Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}