Physical Therapy Using Virtual Reality/Augmented Reality

Not Applicable

Completed

• Conditions: Mobility Limitation; Spinal Fusion; Acute Pain
• Interventions: Other: Virtual Reality/Augmented Reality Headset

• Registration Number: NCT03874507
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Study Start: 2019-07-25
• Primary Completion: 2020-04-25
• Study Completion: 2020-04-25
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Age 6-99
• Diagnosis need for physical rehabilitation

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Technology-based therapy	Virtual Reality/Augmented Reality Headset	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.

Primary Outcome Measures

Name	Time	Method
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'
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 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).

Trial Locations

Locations (2)

Stanford Health Care Hospital; 🇺🇸 Stanford, California, United States

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States