Change in Pain With Virtual Reality-augmented Remote Rehabilitative Care

NCT ID: NCT05253157

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-09-30

Brief Summary

Pain is among the most common chronic conditions in the adult population, often associated with decreased quality of life, functional impairments, increased medication use, increased medical expenditures, and significant economic costs. Due to the worsening opioid crisis, non-pharmacological approaches, such as rehabilitative care, are needed. However, access to in-person rehabilitative care may be limited due to transportation barriers, time constraints, and patient preference to remain at home. The COVID-19 pandemic has further exacerbated barriers to access in-person care, bringing the benefits of tele-rehabilitation into sharper focus. Remote models of care and novel treatment strategies, specifically the utilization of virtual reality (VR) augmented care are emerging as potentially viable treatment alternatives. This paper intends to explore the potential effectiveness of this method of care delivery in patients presenting for rehabilitative care with a primary complaint of pain.

Detailed Description

The investigators are proposing a retrospective health and medical records review with a waiver of consent on 52 patients who had remote VR-augmented rehabilitation services from Aug 2020 to Sept of 2021 at XRHealth, a telehealth rehabilitation company utilizing virtual reality applications to augment traditional rehabilitative care. Included patients had an initial and follow-up score on the brief pain interference scale-intensity and severity to explore the association with remote care and changes over time in this validated outcome assessment. In addition, VR headset data will be analyzed to explore the usage and type of VR applications by primary treatment region to help inform the establishment of optimal treatment protocols and explore the association between changes by applications used. De-identified data will be extracted from the proprietary XR Health data portal and will include a unique patient identifier, qualitative and quantitative ratings on the patient experience with XRHealth, number of treatment visits, usage in minutes of the VR applications utilized, and scores on the Brief Pain Inventory: Interference and Severity sub scales. Individual patient records will be reviewed to extract information regarding co-morbidities, condition chronicity, and medications used.

Conditions

Musculoskeletal Pain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

Virtual Reality Augmented remote rehabilitation

XRHealth offers remote skilled therapy treatments such as education, exercise, and VR-augmented activities. The platform consists of the VRHealth portal with multiple immersive applications for measurement, motor-cognitive training, and mindfulness/cognitive behavioral applications for symptom relief, the external control application, and the XR Health data portal with real-time analytics for evaluating performance. Contraindications for VR use are assessed. Treatment sessions are 60 min long. Duration and frequency are based on clinical judgement. VR interventions used are; VR motor-cognitive: ReAct, Color Match, Memorize, Rotate, and Balloon Blast; VR Reliever: Relax 8, Luna, and Mindset. An external VR portal and mirroring software allows the clinician to view patient activities in real time. Additionally, the clinician can remotely monitor patient performance via the external portal and adjust parameters accordingly.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• presented for treatment at XRHealth with the primary complaint of musculoskeletal pain

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

XRHealth USA Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorna Brown

Role: PRINCIPAL_INVESTIGATOR

XRHealth USA Inc.

Locations

XRHealth USA, Inc

Brookline, Massachusetts, United States

Countries

United States

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Other Identifiers

#2022B1014

Identifier Type: -

Identifier Source: org_study_id