VR-Based Physical Therapy Pilot Study (VR-PT)

The purpose of this study is to evaluate the feasibility and acceptability of using the virtual reality-based physical therapy platform in patients with extremity fracture.

Study Overview

• Status: Completed
• Conditions: Extremity Fracture Lower
• Intervention / Treatment: Other: Virtual Reality Physical Therapy

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-65 years old
• Diagnosed with an operative fracture of the femur and/or tibia
• referred to physical therapy as standard of care

Exclusion Criteria:

• Injury Severity Score(ISS) > 18
• bilateral lower extremity injuries that preclude crutch ambulation
• associated spine fractures
• Glasgow Coma scale (GCS) < 15 at time of discharge
• major peripheral nerve injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Physical Therapy; Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session.	Other: Virtual Reality Physical Therapy; Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction with the virtual reality based physical therapy platform. Patient satisfaction will be assessed using a questionnaire created for this study.	Assessed directly after virtual reality physical therapy session
Patient Preference	Patient preference for virtual reality-based physical therapy when compared to standard supervised office based physical therapy. Patient preference will be assessed using a questionnaire created for this study.	Assessed directly after virtual reality physical therapy session

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: AO North America; KairosXR

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2019
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: D19021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No