Virtual Reality Instructional Design in Orthopedic Physical Therapy Education

• ClinicalTrials.gov Identifier: NCT04754568
• Recruitment Status: Completed
• First Posted: February 15, 2021
• Last Update Posted: September 21, 2021
• Sponsor: Shenandoah University
• Information provided by (Responsible Party): Aaron Hartstein, Shenandoah University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Virtual Reality	Other: Virtual reality instructional design; Other: Role-playing instructional design	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Virtual Reality Instructional Design in Orthopedic Physical Therapy Education: A Randomized Controlled Trial Comparing the Effects of Virtual Reality With Role-Playing Learning
• Actual Study Start Date: January 1, 2020
• Actual Primary Completion Date: June 1, 2021
• Actual Study Completion Date: August 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Virtual reality instructional design; Completion of virtual reality simulation of an outpatient physical therapy evaluation.	Other: Virtual reality instructional design; 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	Other: Role-playing instructional design; 60 minute traditional role-playing with standardized patient

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Virginia

Shenandoah University

Winchester, Virginia, United States, 22601

Sponsors and Collaborators

Shenandoah University

Investigators

• Study Chair: Patti Berg-Poppe, PT, PhD; University of South Dakota

More Information

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.

• Responsible Party: Aaron Hartstein, Associate Professor, Shenandoah University
• ClinicalTrials.gov Identifier: NCT04754568
• Other Study ID Numbers: USD Paper 3
• First Posted: February 15, 2021
• Last Update Posted: September 21, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No