Physical Therapy Using Virtual Reality/Augmented Reality

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874507
• Other study ID #: 50159
• Status: Completed
• Phase: N/A
• Start date: July 25, 2019
• Est. completion date: April 25, 2020

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 25, 2020
• Est. primary completion date: April 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Mobility Limitation
• Spinal Fusion

Intervention

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.

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital Stanford	Palo Alto	California
United States	Stanford Health Care Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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