Physical Therapy Using Virtual Reality/Augmented Reality

Study Overview
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Brief Summary
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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.

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

Conditions
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Mobility Limitation, Spinal Fusion, Acute Pain

Intervention / Treatment
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* Other: Virtual Reality/Augmented Reality Headset


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technology-based therapy<br>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<br>* 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.<br>|
| No Intervention: Standard of Care therapy<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, augmented reality, physical therapy, deconditioning