Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-27 @ 1:24 AM
Study NCT ID:
NCT04754568
Status:
COMPLETED
Last Update Posted:
2021-09-21
First Post:
2021-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Instructional Design in Orthopedic Physical Therapy Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2021-02-08', 'studyFirstSubmitQcDate': '2021-02-11', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in clinical decision-making', 'timeFrame': 'pre- and post-instructional design (immediately after completing virtual reality or role-playing)', 'description': 'The Clinical Decision-Making Tool (CDM-Tool), a Likert-style questionnaire with 12 items, scored on a four-point scale. A higher raw score indicates a higher level of perceived decision-making ability.'}], 'secondaryOutcomes': [{'measure': 'Change in metacognitive awareness', 'timeFrame': 'pre and post-instructional design (immediately after completing virtual reality or role-playing)', 'description': 'Metacognitive Awareness Inventory (MAI), a Likert-style questionnaire with 52-items, scored on a five-point scale. A higher raw score indicates a higher level of perceived metacognitive awareness.'}, {'measure': 'Self-reported measure of engagement', 'timeFrame': 'Post-instruction (immediately after completing either virtual reality or role-playing experience)', 'description': 'Six-item, five-point Likert-style instrument. A higher raw score indicates greater level of student engagement.'}, {'measure': 'Objective Structured Clinical Examination (OSCE)', 'timeFrame': '1 week following allocated instruction (either virtual reality or role-playing)', 'description': "Practical examination with 2 cases, assessing a student's ability to generate hypotheses, perform tests or measures to rule-in or rule-out hypotheses, and deliver an appropriate intervention."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Virtual Reality']}, 'referencesModule': {'references': [{'pmid': '26577020', 'type': 'BACKGROUND', 'citation': 'Kleinert R, Heiermann N, Plum PS, Wahba R, Chang DH, Maus M, Chon SH, Hoelscher AH, Stippel DL. Web-Based Immersive Virtual Patient Simulators: Positive Effect on Clinical Reasoning in Medical Education. J Med Internet Res. 2015 Nov 17;17(11):e263. doi: 10.2196/jmir.5035.'}, {'pmid': '30204773', 'type': 'BACKGROUND', 'citation': 'Middeke A, Anders S, Schuelper M, Raupach T, Schuelper N. Training of clinical reasoning with a Serious Game versus small-group problem-based learning: A prospective study. PLoS One. 2018 Sep 11;13(9):e0203851. doi: 10.1371/journal.pone.0203851. eCollection 2018.'}, {'pmid': '32044851', 'type': 'BACKGROUND', 'citation': 'Middeke A, Anders S, Raupach T, Schuelper N. Transfer of Clinical Reasoning Trained With a Serious Game to Comparable Clinical Problems: A Prospective Randomized Study. Simul Healthc. 2020 Apr;15(2):75-81. doi: 10.1097/SIH.0000000000000407.'}]}, 'descriptionModule': {'briefSummary': "The objective of this study is to assess the effects of virtual reality instructional design on physical therapy students' clinical decision-making skills, as compared with a traditional method of instruction with the same content and duration of exposure.", 'detailedDescription': 'An online random number generator will be used to randomize students into one of two groups: virtual reality instruction or role-paying instruction. All students will complete self-reported measures of clinical decision-making and metacognitive awareness prior to receiving their allocated instruction. While completing allocated instruction (either virtual reality or role-playing), measures of diagnostic accuracy and diagnostic efficiency will be collected. Following virtual reality or role-playing instruction, all included subjects will complete post-test measures of clinical decision-making ,metacognitive awareness, and engagement. One week later, all included subjects will be assessed on a musculoskeletal objective structured clinical examination (mOSCE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students enrolled in their first year of physical therapy school at SU\n\nExclusion Criteria:\n\n* Students enrolled in their second or third year of physical therapy school at SU'}, 'identificationModule': {'nctId': 'NCT04754568', 'briefTitle': 'Virtual Reality Instructional Design in Orthopedic Physical Therapy Education', 'organization': {'class': 'OTHER', 'fullName': 'Shenandoah University'}, 'officialTitle': 'Virtual Reality Instructional Design in Orthopedic Physical Therapy Education: A Randomized Controlled Trial Comparing the Effects of Virtual Reality With Role-Playing Learning', 'orgStudyIdInfo': {'id': 'USD Paper 3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality instructional design', 'description': 'Completion of virtual reality simulation of an outpatient physical therapy evaluation.', 'interventionNames': ['Other: Virtual reality instructional design']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Role-playing instructional design', 'description': 'Completion of traditional role-playing of a scripted outpatient physical therapy evaluation', 'interventionNames': ['Other: Role-playing instructional design']}], 'interventions': [{'name': 'Virtual reality instructional design', 'type': 'OTHER', 'description': '60 minute immersive VR experience with branching method information delivery, physical therapy assessment, and diagnosis.', 'armGroupLabels': ['Virtual reality instructional design']}, {'name': 'Role-playing instructional design', 'type': 'OTHER', 'description': '60 minute traditional role-playing with standardized patient', 'armGroupLabels': ['Role-playing instructional design']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22601', 'city': 'Winchester', 'state': 'Virginia', 'country': 'United States', 'facility': 'Shenandoah University', 'geoPoint': {'lat': 39.18566, 'lon': -78.16333}}], 'overallOfficials': [{'name': 'Patti Berg-Poppe, PT, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of South Dakota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenandoah University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Aaron Hartstein', 'investigatorAffiliation': 'Shenandoah University'}}}}