- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04754568
Virtual Reality Instructional Design in Orthopedic Physical Therapy Education
September 20, 2021 updated by: Aaron Hartstein, Shenandoah University
Virtual Reality Instructional Design in Orthopedic Physical Therapy Education: A Randomized Controlled Trial Comparing the Effects of Virtual Reality With Role-Playing Learning
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Winchester, Virginia, United States, 22601
- Shenandoah University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Students enrolled in their first year of physical therapy school at SU
Exclusion Criteria:
- Students enrolled in their second or third year of physical therapy school at SU
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual reality instructional design
Completion of virtual reality simulation of an outpatient physical therapy evaluation.
|
60 minute immersive VR experience with branching method information delivery, physical therapy assessment, and diagnosis.
|
|
Active Comparator: Role-playing instructional design
Completion of traditional role-playing of a scripted outpatient physical therapy evaluation
|
60 minute traditional role-playing with standardized patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in clinical decision-making
Time Frame: pre- and post-instructional design (immediately after completing virtual reality or role-playing)
|
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.
|
pre- and post-instructional design (immediately after completing virtual reality or role-playing)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in metacognitive awareness
Time Frame: pre and post-instructional design (immediately after completing virtual reality or role-playing)
|
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.
|
pre and post-instructional design (immediately after completing virtual reality or role-playing)
|
|
Self-reported measure of engagement
Time Frame: Post-instruction (immediately after completing either virtual reality or role-playing experience)
|
Six-item, five-point Likert-style instrument.
A higher raw score indicates greater level of student engagement.
|
Post-instruction (immediately after completing either virtual reality or role-playing experience)
|
|
Objective Structured Clinical Examination (OSCE)
Time Frame: 1 week following allocated instruction (either virtual reality or role-playing)
|
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.
|
1 week following allocated instruction (either virtual reality or role-playing)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Patti Berg-Poppe, PT, PhD, University of South Dakota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
June 1, 2021
Study Completion (Actual)
August 1, 2021
Study Registration Dates
First Submitted
February 8, 2021
First Submitted That Met QC Criteria
February 11, 2021
First Posted (Actual)
February 15, 2021
Study Record Updates
Last Update Posted (Actual)
September 21, 2021
Last Update Submitted That Met QC Criteria
September 20, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- USD Paper 3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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