NCT04754568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

February 8, 2021

Last Update Submit

September 20, 2021

Conditions

Virtual Reality

Outcome Measures

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.

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

Secondary Outcomes (3)

  • Change in metacognitive awareness

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

  • Self-reported measure of engagement

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

  • Objective Structured Clinical Examination (OSCE)

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

Study Arms (2)

Virtual reality instructional design

EXPERIMENTAL

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

Other: Virtual reality instructional design

Role-playing instructional design

ACTIVE COMPARATOR

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

Other: Role-playing instructional design

Interventions

Virtual reality instructional designOTHER

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

Virtual reality instructional design
Role-playing instructional designOTHER

60 minute traditional role-playing with standardized patient

Role-playing instructional design

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenandoah University

Winchester, Virginia, 22601, United States

Location

Related Publications (3)

  • 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: 26577020BACKGROUND

  • 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: 30204773BACKGROUND

  • 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.

    PMID: 32044851BACKGROUND

Study Officials

  • Patti Berg-Poppe, PT, PhD

    University of South Dakota

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 15, 2021

Study Start

January 1, 2020

Primary Completion

June 1, 2021

Study Completion

August 1, 2021

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)