Physical Therapy Using Virtual Reality/Augmented Reality

Sponsor

Stanford University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03874507

Collaborator

(none)

250

Enrollment

Locations

Arms

43.5

Anticipated Duration (Months)

125

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mobility Limitation Spinal Fusion Acute Pain	Other: Virtual Reality/Augmented Reality Headset	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 25, 2019

Anticipated Primary Completion Date :

Dec 25, 2022

Anticipated Study Completion Date :

Mar 10, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Aggregate Movement [Duration of physical therapy, approximately 10 minutes]
Aggregate movement will be measured by either sensors in the VR/AR headset or by a physical therapist during the participants session
Patient and Physical Therapist Feedback [Survey of patient and PT satisfaction will be administered after the physical therapy session, duration of survey should take approximately 15 minutes or less]
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'
Patient Fatigue [OMNI PRE Questionnaire will be administered after the physical therapy session, duration of questionnaire should take approximately 15 minutes or less]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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