Virtual Reality for Physical Therapy

(iMOVE-G Trial)

Overseen By Man Yee Suen

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Neurological condition, Developmental disability, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 sessions

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an experimental study to evaluate the efficacy of a Virtual Reality aid Physical Therapy (VRPT) in increasing the physical activity levels and quality of life of children.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment Virtual Reality Physical Therapy?

Research shows that virtual reality can enhance physical therapy by improving patient engagement and has been beneficial for stroke patients and those with motor deficits. A case study also demonstrated improved balance and motor function in a patient with a brain injury using VR-based therapy. ^{1 2 3 4 5}

Is virtual reality for physical therapy safe for humans?

A study on immersive virtual reality for brain rehabilitation found it to be generally safe, with no serious adverse events reported, although some patients experienced dizziness. ^{3 5 6 7 8}

How is Virtual Reality Physical Therapy different from other treatments for physical therapy?

Virtual Reality Physical Therapy (VRPT) is unique because it allows patients to receive physical therapy remotely, overcoming barriers to access that prevent many from attending in-office sessions. It also enhances patient engagement by making exercises more interactive and immersive, which can lead to better outcomes compared to traditional physical therapy alone. ^{1 2 3 7 9}

Research Team

Thomas Caruso

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for children and young adults aged 7-25 who are currently undergoing physical therapy and expected to be inpatients for over two days. It's not suitable for those who may have conditions preventing them from using VR.

Inclusion Criteria

I am currently seeing a physical therapist.

I am between 7 and 25 years old.

I expect to stay in the hospital for more than 2 days.

Exclusion Criteria

Legal guardian not present to obtain consent

My child has a major neurological or developmental condition.

History of severe motion sickness

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive traditional Physical Therapy sessions followed by Virtual Reality assisted Physical Therapy sessions, or vice versa, under the supervision of an accredited physical therapist

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for changes in mental well-being, fatigue, and total movement immediately after each physical therapy session

immediately after each session

Treatment Details

Interventions

• Virtual Reality Physical Therapy

Trial Overview The study is testing if Virtual Reality Physical Therapy (VRPT) can boost physical activity levels and improve quality of life compared to traditional methods in a pediatric setting.

Participant Groups

Group I: Traditional PT then VRPT Experimental Treatment 2 Interventions

Participants will receive traditional Physical Therapy (PT) sessions (standard care) in the first Physical Therapy session and receive Virtual Reality assisted Physical Therapy sessions (VRPT) in the second Physical Therapy session under the supervision of the accredited physical therapist.

Group II: Experimental: VRPT then Traditional PT Experimental Treatment 2 Interventions

Participants will receive Virtual Reality assisted Physical Therapy sessions (VRPT) in the first Physical Therapy (PT) session and will receive traditional Physical Therapy sessions (standard care) in the second Physical Therapy session under the supervision of the accredited physical therapist.

Virtual Reality Physical Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Virtual Reality Physical Therapy for:

• Rehabilitation for stroke
• Traumatic brain injury
• Low back pain
• Balance issues
• Osteoarthritis
• Neurological conditions (e.g., Parkinson disease, multiple sclerosis)
• Orthopedic rehabilitation
• Chronic pain management

Approved in European Union as Virtual Reality Physical Therapy for:

• Rehabilitation for neurological disorders
• Musculoskeletal injuries
• Post-surgery recovery
• Vestibular disorders
• Pediatric conditions (e.g., autism, Down syndrome, cerebral palsy)

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

In a study involving 41 participants aged 6 to 80, physical therapy supplemented with virtual reality led to significantly more movement (1120.88 m) compared to traditional physical therapy alone (672.65 m), indicating enhanced engagement and effectiveness of the virtual reality approach.

Both patients and physical therapists reported satisfaction with the virtual reality-enhanced therapy, suggesting it is a promising tool for improving physical therapy outcomes without increasing perceived exertion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Augments Movement During Physical Therapy: A Pragmatic Randomized Trial. Hemphill, S., Rodriguez, S., Wang, E., et al.[2023]

A pilot study involving 15 orthopedic trauma patients showed that a Virtual Reality physical therapy (VR-PT) program was well-received, with an average enjoyment rating of 7.5 out of 10, indicating high patient engagement.

Patients expressed a strong interest in participating in further trials of VR-PT, suggesting that this innovative approach could improve access to physical therapy for those unable to attend traditional in-office sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality-based physical therapy for patients with lower extremity injuries: feasibility and acceptability. Reilly, CA., Greeley, AB., Jevsevar, DS., et al.[2022]

Virtual reality-assisted therapy (VRAT) significantly improves vestibular symptoms in patients with peripheral vestibular disorders compared to conventional vestibular physical therapy (CVPT), as shown by various measures including the Dizziness Handicap Inventory (DHI).

While VRAT shows promise for enhancing rehabilitation outcomes, particularly for peripheral disorders, the high variability in study results indicates a need for further research with larger sample sizes to better understand its effectiveness across different vestibular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Virtual Reality-Assisted Therapy Offer Additional Benefits to Patients With Vestibular Disorders Compared With Conventional Vestibular Physical Therapy? A Meta-analysis. Chu, HY., Song, N., Zhou, ZR., et al.[2023]

A 58-year-old man with right hemiplegia showed significant improvements in gait and lower limb motor function after 8 weeks of VR-based physical therapy combined with traditional therapy, indicating the efficacy of this approach.

The use of VR technology provided real-time feedback that enhanced rehabilitation outcomes, as evidenced by increased step length, stride length, and a rise in the Fugl-Meyer assessment score from 18 to 23 points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Balance, Gait, and Lower Limb Motor Function in a 58-Year-Old Man with Right Hemiplegic Traumatic Brain Injury Following Virtual Reality-Based Real-Time Feedback Physical Therapy. Kim, KH., Kim, DH.[2023]

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]

The study involving 78 patients with brain injury found that immersive virtual reality (VR) training is safe, with no serious adverse events reported, although some patients experienced minor issues like dizziness.

Patients who adhered to the VR training (participating 3 or more times) reported higher satisfaction and perceived effectiveness in their recovery from upper limb paralysis compared to those who participated less frequently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. Lim, I., Cha, B., Cho, DR., et al.[2023]

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]

A national survey of 1071 physical and occupational therapists in Canada revealed that while 46% had experience with virtual reality (VR) and active video gaming (AVG), only 12% were currently using these technologies in practice, primarily for rehabilitation targeting balance and physical activity outcomes.

Key barriers to using VR/AVG included lack of funding, space, and time, while facilitators were client motivation and therapist knowledge; most therapists expressed a strong interest in further training to enhance their use of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality and Active Videogame-Based Practice, Learning Needs, and Preferences: A Cross-Canada Survey of Physical Therapists and Occupational Therapists. Levac, D., Glegg, S., Colquhoun, H., et al.[2021]

A systematic review of 29 studies on virtual reality (VR) rehabilitation for gait, posture, and balance revealed that most interventions were delivered by physical therapists, primarily focusing on supervision and safeguarding rather than active clinical reasoning or tailoring of the therapy.

The review highlighted a lack of detailed reporting on the rationale for technology and activity selection in VR interventions, which limits the ability to replicate these studies and develop effective clinical guidelines for therapists' roles in VR rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Commercially Available Virtual Reality-Based Interventions Are Delivered and Reported in Gait, Posture, and Balance Rehabilitation: A Systematic Review. Weber, H., Barr, C., Gough, C., et al.[2020]

References

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

Virtual Reality Augments Movement During Physical Therapy: A Pragmatic Randomized Trial. [2023]

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

Virtual reality-based physical therapy for patients with lower extremity injuries: feasibility and acceptability. [2022]

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

Can Virtual Reality-Assisted Therapy Offer Additional Benefits to Patients With Vestibular Disorders Compared With Conventional Vestibular Physical Therapy? A Meta-analysis. [2023]

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

Improved Balance, Gait, and Lower Limb Motor Function in a 58-Year-Old Man with Right Hemiplegic Traumatic Brain Injury Following Virtual Reality-Based Real-Time Feedback Physical Therapy. [2023]

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

When is virtual reality "therapy"? [2013]

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

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. [2023]

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

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

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

Virtual Reality and Active Videogame-Based Practice, Learning Needs, and Preferences: A Cross-Canada Survey of Physical Therapists and Occupational Therapists. [2021]

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

How Commercially Available Virtual Reality-Based Interventions Are Delivered and Reported in Gait, Posture, and Balance Rehabilitation: A Systematic Review. [2020]