Simulated Environment for Virtual Reality Therapy

Overseen By Caitlin Burke, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Under 18, Non-ambulatory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 11 days

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators believe that rehabilitation specialists will use community reintegration treatments more if a simulated environment is available.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Simulated Environment for Virtual Reality Therapy?

Research shows that virtual reality (VR) systems, like the Nintendo Wii, have been used effectively in physical therapy to improve balance in people with traumatic brain injury and to aid recovery after hip surgery. These studies suggest that VR can be a helpful tool in rehabilitation by making exercises more engaging and providing immediate feedback. ^{1 2 3 4 5}

Is virtual reality therapy generally safe for humans?

Virtual reality therapy is generally considered safe, but some users may experience side effects like eye strain, disorientation, balance issues, and nausea. These effects can vary based on individual factors like age and physical fitness, as well as the design of the VR system. ^{1 6 7 8 9}

How does the Simulated Environment for Virtual Reality Therapy differ from other treatments for PT and OT?

This treatment uses virtual reality (VR) to create interactive, simulated environments that are engaging and motivating, allowing patients to practice movements and tasks in a way that mimics real-world experiences. Unlike traditional therapies, VR can provide multimodal feedback and be adapted for remote or multi-user settings, offering a unique and flexible approach to rehabilitation. ^{1 10 11 12 13}

Research Team

Nasim Chowdhury, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for adults over 18 who can walk a bit and read English. They must have used a simulated environment during their stay in the Inpatient Rehabilitation Unit and be going home after rehab. People under 18, non-English readers, those not ambulatory for medical reasons, or with low cognitive scores are excluded.

Inclusion Criteria

I am 18 or older and admitted to the Inpatient Rehabilitation Unit.

I can walk 10 feet on my own with little difficulty.

Patients who can read and provide informed consent in English

Exclusion Criteria

Patients who score 7 or lower on the BIMS on initial evaluation

Patients who did not use the simulated environment during their inpatient stay

I was moved to another care facility after my hospital rehab.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo community reintegration training using a simulated environment during their inpatient rehabilitation stay

11 days

Daily sessions during inpatient stay

Follow-up

Participants are monitored for functional outcomes and patient satisfaction post-discharge

30 days

1 visit (virtual or in-person)

Treatment Details

Interventions

• PT and OT

Trial Overview The study tests if rehabilitation specialists will more frequently use community reintegration treatments when they have access to a simulated environment. It involves physical therapy (PT) and occupational therapy (OT) within this virtual setting.

Participant Groups

Group I: Community Reintegration in Simulated Environment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Hunter College of The City University of New York

Collaborator

Trials

4

Recruited

310+

Findings from Research

The use of virtual reality (VR) in physical rehabilitation is growing, but there is a need for clear definitions and understanding of what 'VR therapy' entails.

Clinicians must critically examine how VR is implemented in practice and seek evidence to support its integration into rehabilitation, ensuring that therapists are well-informed about its applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When is virtual reality "therapy"? Levac, DE., Galvin, J.[2013]

A 12-week home-based physical therapy program using virtual reality (VR) did not show significant advantages over a traditional home exercise program (HEP) in improving balance for individuals with traumatic brain injury (TBI).

Both the VR and traditional HEP groups demonstrated significant improvements in balance measures over time, indicating that independent home-based interventions can be effective for enhancing balance in chronic TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results From a Randomized Controlled Trial to Address Balance Deficits After Traumatic Brain Injury. Tefertiller, C., Hays, K., Natale, A., et al.[2022]

In a randomized controlled trial involving 73 patients over 50 years old who underwent total hip arthroplasty, adding virtual reality exercises with the Nintendo Wii to standard physiotherapy significantly improved functional outcomes, as measured by the WOMAC questionnaire and other balance and mobility tests.

While the intervention group showed statistically significant improvements in function and balance compared to the control group, these differences were not considered clinically important, suggesting that while virtual reality can enhance rehabilitation, its practical impact may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of adding virtual reality to physiotherapeutic treatment in patients with total hip arthroplasty. A randomized controlled trial. Zavala-González, J., Martínez, D., Gutiérrez-Espinoza, H.[2022]

Physical therapists reported that using the Nintendo Wii in rehabilitation for children with acquired brain injuries presents both benefits and challenges, highlighting the need for therapists to adapt to this technology in their practice.

The study emphasizes the importance of institutional support and professional development to effectively integrate virtual reality tools like the Wii into physical therapy, ensuring therapists are well-equipped to implement these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating virtual reality video games into practice: clinicians' experiences. Levac, DE., Miller, PA.[2022]

Virtual reality and active video games (VR/AVGs) show promise as rehabilitation tools due to their engaging and feedback-rich nature, but their clinical adoption is still low despite evidence supporting their effectiveness.

Barriers to the integration of VR/AVGs in clinical practice include knowledge gaps and resource limitations, highlighting the need for targeted knowledge translation strategies to improve clinician skills and attitudes towards these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers, Facilitators and Interventions to Support Virtual Reality Implementation in Rehabilitation: A Scoping Review. Glegg, SMN., Levac, DE.[2020]

The HTC VIVE virtual reality system, when configured for portability, showed a mean translational error of below 4.9 cm during motion tracking, which is higher than research-grade systems but still valid for tracking aggregate movement in physical therapy.

The advantages of using the portable VIVE system, such as increased accessibility for patients in various therapy settings, may outweigh its limitations in precision, making it a useful tool for both inpatient and outpatient physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobilization and calibration of the HTC VIVE for virtual reality physical therapy. Hemphill, S., Nguyen, A., Rodriguez, ST., et al.[2022]

Orthopaedic physical therapy is generally considered safe, but there is a lack of high-quality data documenting its safety, particularly regarding cervical manipulation, highlighting the need for more rigorous research on potential harms.

Current research shows poor reporting standards for adverse events in orthopaedic physical therapy, indicating a need for standardized terminology and better documentation practices to ensure informed consent and clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. Carlesso, LC., Macdermid, JC., Santaguida, LP.[2022]

Virtual reality (VR) has promising applications in medicine, such as surgical training and rehabilitation, but users may experience side effects like nausea and disorientation, which can vary based on individual factors like age and physical fitness.

To ensure the safety and effectiveness of VR applications in clinical settings, it is crucial to design systems that minimize side effects and establish protocols for monitoring patient exposure, especially for those with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human factors consideration in clinical applications of virtual reality. Lewis, CH., Griffin, MJ.[2005]

An umbrella review of 41 meta-analyses found mostly low- to very low-quality evidence supporting the effectiveness of virtual reality (VR) interventions in the rehabilitation of patients with neurological disorders, such as stroke and cerebral palsy.

Despite the potential benefits of VR for improving functions like ambulation in children with cerebral palsy and mobility in stroke patients, most studies did not adequately address safety concerns, highlighting the need for high-quality randomized controlled trials to establish robust evidence and guidelines for VR rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality in Neurorehabilitation: An Umbrella Review of Meta-Analyses. Voinescu, A., Sui, J., Stanton Fraser, D.[2021]

Virtual Reality (VR) offers a motivating and engaging environment for rehabilitation, allowing users to participate in interactive experiences that can enhance their therapy outcomes.

The use of advanced technologies in VR, such as motion tracking and haptic feedback, creates realistic simulations that can effectively replicate real-world interactions, potentially improving motor rehabilitation results compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor rehabilitation using virtual reality. Sveistrup, H.[2022]

Virtual Reality (VR) technologies are transforming neuro-rehabilitation by providing interactive simulations that help achieve therapeutic goals that traditional methods struggle to meet.

Recent advancements in VR are expanding rehabilitation approaches to include multiple users, both in the same location and remotely, which could enhance collaboration and effectiveness in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving beyond single user, local virtual environments for rehabilitation. Weiss, PL., Klinger, E.[2016]

The integration of high-speed networking with virtual environments (VE) can significantly enhance rehabilitation services, allowing for remote access and the development of innovative networked rehabilitation systems.

Data from immersive virtual environments indicate that healthy adults respond to combined sensory inputs (visual, vestibular, and proprioceptive) in a way that suggests all signals contribute to postural responses, highlighting the importance of individual sensory perception in tailoring rehabilitation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations for the future development of virtual technology as a rehabilitation tool. Kenyon, RV., Leigh, J., Keshner, EA.[2022]

Virtual reality (VR) shows promise as a safe and beneficial tool for stroke rehabilitation, with studies indicating positive outcomes in areas like upper limb rehabilitation, gait, and balance.

However, the overall quality of evidence is weak to moderate, with only three randomized controlled trials showing statistical significance, highlighting the need for more rigorous research to fully assess VR's effectiveness in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality in stroke rehabilitation: still more virtual than real. Crosbie, JH., Lennon, S., Basford, JR., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

When is virtual reality "therapy"? [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Results From a Randomized Controlled Trial to Address Balance Deficits After Traumatic Brain Injury. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of adding virtual reality to physiotherapeutic treatment in patients with total hip arthroplasty. A randomized controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Integrating virtual reality video games into practice: clinicians' experiences. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Barriers, Facilitators and Interventions to Support Virtual Reality Implementation in Rehabilitation: A Scoping Review. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Mobilization and calibration of the HTC VIVE for virtual reality physical therapy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Human factors consideration in clinical applications of virtual reality. [2005]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality in Neurorehabilitation: An Umbrella Review of Meta-Analyses. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Motor rehabilitation using virtual reality. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Moving beyond single user, local virtual environments for rehabilitation. [2016]

12. England pubmed.ncbi.nlm.nih.gov

Considerations for the future development of virtual technology as a rehabilitation tool. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Virtual reality in stroke rehabilitation: still more virtual than real. [2016]