Virtual RealityNCT04754568
Virtual Reality Instructional Design in Orthopedic Physical Therapy Education
A study testing Virtual reality instructional design and Role-playing instructional design in people with Virtual Reality, run by Shenandoah University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Virtual reality instructional design and Role-playing instructional design
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Students enrolled in their first year of physical therapy school at SU
Who cannot join
- Students enrolled in their second or third year of physical therapy school at SU
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Virtual Reality
- Being tested
- Virtual reality instructional design, Role-playing instructional design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality instructional designOther
60 minute immersive VR experience with branching method information delivery, physical therapy assessment, and diagnosis.
Role-playing instructional designOther
60 minute traditional role-playing with standardized patient
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality instructional design | Experimental | Completion of virtual reality simulation of an outpatient physical therapy evaluation. Receives: Other: Virtual reality instructional design |
| Role-playing instructional design | Active comparator | Completion of traditional role-playing of a scripted outpatient physical therapy evaluation Receives: Other: Role-playing instructional design |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre- and post-instructional design (immediately after completing virtual reality or role-playing)
Secondary outcomes (3)
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.
Measured: pre and post-instructional design (immediately after completing virtual reality or role-playing)
Self-reported measure of engagement
Six-item, five-point Likert-style instrument. A higher raw score indicates greater level of student engagement.
Measured: Post-instruction (immediately after completing either virtual reality or role-playing experience)
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.
Measured: 1 week following allocated instruction (either virtual reality or role-playing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Jan 2020
- Primary completion1 Jun 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenandoah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Hartstein, Shenandoah University
- Investigators
- Patti Berg-Poppe, PT, PhD, Study chair, University of South Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754568
- Sponsor's protocol ID
- USD Paper 3
- Status last verified
- Sep 2021
- First submitted
- 8 Feb 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 26577020Middeke 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 30204773Middeke 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04754568
- Acronym / sponsor ID
- USD Paper 3
- Conditions
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Shenandoah UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality instructional design | Experimental | Other: Virtual reality instructional designCompletion of virtual reality simulation of an outpatient physical therapy evaluation. |
| Role-playing instructional design | Active comparator | Other: Role-playing instructional designCompletion of traditional role-playing of a scripted outpatient physical therapy evaluation |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Students enrolled in their first year of physical therapy school at SU
Key exclusion criteria (1 listed)
- Students enrolled in their second or third year of physical therapy school at SU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality instructional design60 minute immersive VR experience with branching method information delivery, physical therapy assessment, and diagnosis. | Other | Virtual reality instructional design |
| Role-playing instructional design60 minute traditional role-playing with standardized patient | Other | Role-playing instructional design |
Primary outcome
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.
3 secondary outcomes
Change in metacognitive awareness
Time frame: 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)
Objective Structured Clinical Examination (OSCE)
Time frame: 1 week following allocated instruction (either virtual reality or role-playing)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Background: PubMed 26577020Kleinert 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.
- Background: PubMed 30204773Middeke 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.
- Background: PubMed 32044851Middeke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patti Berg-Poppe, PT, PhD study chair
University of South Dakota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality instructional design and Role-playing instructional design in people with Virtual Reality, run by Shenandoah University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical decision-making (time frame: pre- and post-instructional design (immediately after completing virtual reality or role-playing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754568, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.