Physical Therapy Using Virtual Reality/Augmented Reality

Technology-Based Intervention for Physical Therapy in Pediatric and Adult Populations

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality (VR) headset, Augmented Reality (AR) Headset) are more effective than the standard of care (i.e., no technology-based distraction) for improving clinical outcomes in patients requiring acute rehabilitation due to deconditioning and surgery. Measures will include include range of motion, gait progression, strength progression, time to first out of bed, time to first step.

Study Overview

• Status: Completed
• Conditions: Acute Pain; Mobility Limitation; Spinal Fusion
• Intervention / Treatment: Other: Virtual Reality/Augmented Reality Headset

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital Stanford
    • Stanford, California, United States, 94304
      • Stanford Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 6-99
• Diagnosis need for physical rehabilitation

Exclusion Criteria:

• Significant Cognitive Impairment
• History of Severe Motion Sickness
• Current Nausea
• Seizures
• Visual Problems
• Patients whose children are clinically unstable or require urgent/emergent intervention
• Patients who clinically unstable or requires urgent/emergent intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Technology-based therapy; Patients who require acute rehabilitation due to deconditioning and surgery will receive either virtual reality (VR) or augmented reality (AR) to improve clinical outcomes such as range of motion, gait progression, strength progression, time to first out of bed, time to first step.	Other: Virtual Reality/Augmented Reality Headset; A virtual reality (VR) headset is a device the participant will wear over his/her head and eyes like a pair of goggles. It blocks out all external light and shows him/her an image on high-definition screens in front of his/hers eyes. It implies a complete immersion experience that shuts out the physical world. Augmented reality (AR) headset is a device that the participant will wear over his/hers head and eyes and it adds digital elements to a live view.
No Intervention: Standard of Care therapy; Patients who require acute rehabilitation due to deconditioning and surgery will receive physical therapy based on his/her providers recommendations to improve outcomes such as range of motion, gait progression, strength progression, time to first out of bed, time to first step

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aggregate Movement	Aggregate movement will be measured by either sensors in the VR/AR headset or by a physical therapist during the participants session	Duration of physical therapy, approximately 10 minutes
Patient and Physical Therapist Feedback	Survey of patient and PT satisfaction will be administered after the session. Example of survey questions, to which patient answered 'Yes or No,' for patient include 1) 'The VR game helped me during physical therapy' 2) 'I felt less pain when I moved using the VR game' The survey administered to physical therapists will be rated 1-5 (1=Not at all, 5= A lot) with questions such as 1) 'The technology was helpful to my patients during physical therapy' and 2) 'I would like my patient to have access to this technology for future physical therapy sessions'	Survey of patient and PT satisfaction will be administered after the physical therapy session, duration of survey should take approximately 15 minutes or less
Patient Fatigue	Patients will self-report fatigue according to the Adult OMNI-Walk/Run RPE Scale (OMNI RPE) scale after both the VR and standard of care portion. The OMNI RPE is an 11-category perceived exertion rating scale with a numerical rating from 0 to 10 (0= Not Tired at All, 10= Very, Very Tired).	OMNI PRE Questionnaire will be administered after the physical therapy session, duration of questionnaire should take approximately 15 minutes or less

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• Hemphill S, Rodriguez S, Wang E, Koeppen K, Aitken-Young B, Jackson C, Simons L, Caruso TJ. Virtual Reality Augments Movement During Physical Therapy: A Pragmatic Randomized Trial. Am J Phys Med Rehabil. 2022 Mar 1;101(3):229-236. doi: 10.1097/PHM.0000000000001779.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Actual): April 25, 2020
• Study Completion (Actual): April 25, 2020

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: augmented reality; virtual reality; physical therapy; deconditioning
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Mobility Limitation
• Other Study ID Numbers: 50159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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