Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain
NCT ID: NCT04636177
Last Updated: 2025-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2022-03-10
2024-12-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pain Rehabilitation Virtual Reality (PRVR)
Participants will complete VR in PT to engage participants in a series of immersive games customized to align with individual PT needs delivered over \~6-12 weeks or until clinician believes the patient is done with treatment. Patients in the PRVR arm will be given a structured HEP to practice prescribed exercises at home with integrated VR activities. PRVR participants will be allocated a VR headset for use in PT sessions and with HEP. VR will supplement treatment and be used in session (either in-person or telehealth) and at home as part of their prescribed treatment homework.
Pain Rehabilitation Virtual Reality (PRVR)
Participants will receive approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks. Adequate dose: 75% (6 of 8 sessions).
Standard Physiotherapy Rehabilitation (SPR)
Sessions are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 consisting of 1) therapeutic exercise, 2) balance and proprioception, 3) strength training, and 4) use of modalities (e.g., heat/cold pack). Patients will be given a structured Home Exercise Program (HEP) with prescribed exercises for home. SPR participants will be allocated a VR headset for recreational use.
Standard Physiotherapy Rehabilitation (SPR)
Participants allocated to either intervention arm will receive 8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks. Adequate dose: 75% (6 of 8 sessions).
Interventions
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Pain Rehabilitation Virtual Reality (PRVR)
Participants will receive approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks. Adequate dose: 75% (6 of 8 sessions).
Standard Physiotherapy Rehabilitation (SPR)
Participants allocated to either intervention arm will receive 8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks. Adequate dose: 75% (6 of 8 sessions).
Eligibility Criteria
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Inclusion Criteria
* Musculoskeletal pain (e.g. localized \[back, limb\], diffuse) not due to acute trauma (e.g. active sprain or fracture)
* English Language Proficiency
Exclusion Criteria
* Significant medical or psychiatric problem that would interfere (e.g. psychosis, suicidality)
* Presents with a condition that interferes with virtual reality usage (e.g., history of seizure, facial injury precluding safe placement of headset, visual impairment, significant hearing impairment impact ability to follow audio instructions).
10 Years
17 Years
ALL
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Stanford University
OTHER
Responsible Party
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Laura E Simons
Professor
Principal Investigators
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Laura Simons, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford School of Medicine
Locations
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Pediatric Pain Management Clinic - Stanford Children's Health
Menlo Park, California, United States
California Rehabilitation and Sports Therapy
Palo Alto, California, United States
Countries
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References
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Simons LE, Hess CW, Choate ES, Van Orden AR, Tremblay-McGaw AG, Menendez M, Boothroyd DB, Parvathinathan G, Griffin A, Caruso TJ, Stinson J, Weisman A, Liu T, Koeppen K. Virtual Reality-Augmented Physiotherapy for Chronic Pain in Youth: Protocol for a Randomized Controlled Trial Enhanced With a Single-Case Experimental Design. JMIR Res Protoc. 2022 Dec 12;11(12):e40705. doi: 10.2196/40705.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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68669
Identifier Type: -
Identifier Source: org_study_id