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CompletedNCT04754568Updated Sep 21, 2021

Virtual Reality Instructional Design in Orthopedic Physical Therapy Education

An interventional study of Virtual reality instructional design and Role-playing instructional design in Virtual Reality, sponsored by Shenandoah University. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2021-09-21.

Sponsored by Shenandoah University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2020, registered Feb 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Virtual Reality
03

In context

Lead sponsor

Shenandoah University is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Students enrolled in their first year of physical therapy school at SU

Exclusion criteria

Exclusion Criteria:

  • Students enrolled in their second or third year of physical therapy school at SU
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    Virtual reality instructional design

    Completion of virtual reality simulation of an outpatient physical therapy evaluation.

    Other: Virtual reality instructional design

  • Active comparator
    Role-playing instructional design

    Completion of traditional role-playing of a scripted outpatient physical therapy evaluation

    Other: Role-playing instructional design

Interventions

  • OtherVirtual reality instructional design

    60 minute immersive VR experience with branching method information delivery, physical therapy assessment, and diagnosis.

  • OtherRole-playing instructional design

    60 minute traditional role-playing with standardized patient

06

What researchers measure

Primary outcomes

  1. Change in clinical decision-making

    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.

    Time frame: pre- and post-instructional design (immediately after completing virtual reality or role-playing)

Secondary outcomes

  1. Change in metacognitive awareness

    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.

    Time frame: pre and post-instructional design (immediately after completing virtual reality or role-playing)

  2. Self-reported measure of engagement

    Six-item, five-point Likert-style instrument. A higher raw score indicates greater level of student engagement.

    Time frame: Post-instruction (immediately after completing either virtual reality or role-playing experience)

  3. Objective Structured Clinical Examination (OSCE)

    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.

    Time frame: 1 week following allocated instruction (either virtual reality or role-playing)

07

Study locations

1 site
  • Shenandoah University
    Winchester, Virginia 22601, United States
08

References and documents

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. PubMed 26577020 ↗
  • 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. PubMed 30204773 ↗
  • 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. PubMed 32044851 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04754568
Lead sponsor
Shenandoah University
Responsible party
Aaron Hartstein (Associate Professor, Shenandoah University) — Principal investigator
First posted
Feb 15, 2021
Start date
Jan 1, 2020
Primary completion
Jun 1, 2021
Completion
Aug 1, 2021
Last update
Sep 21, 2021

Study contacts

Patti Berg-Poppe, PT, PhD
study chair · University of South Dakota

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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