Virtual Reality vs Traditional Physical Therapy for Children's Physical Health

(iMOVE Trial)

Overseen By Man Yee Suen

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Neurological condition, Developmental disability, Seizures, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

40 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Virtual Reality Physical Therapy for children's physical health?

Research shows that virtual reality can enhance physical therapy by increasing patient engagement and improving movement, as seen in stroke patients. Additionally, virtual reality-based therapy has been found to improve balance and manual ability in children with cerebral palsy, suggesting potential benefits for other pediatric populations. ^{1 2 3 4 5}

Is virtual reality physical therapy safe for children?

Research suggests that virtual reality physical therapy is generally safe for children, as it can improve functional disabilities, alleviate perceived pain, and increase exercise duration without reported adverse effects. ^{1 3 4 6 7}

How does Virtual Reality Physical Therapy differ from Traditional Physical Therapy for children's physical health?

Virtual Reality Physical Therapy is unique because it uses immersive technology to make exercises more engaging and less painful, which can help children participate more fully and enjoyably in their therapy sessions compared to traditional methods. ^{3 4 5 6 8}

What is the purpose of this trial?

This pragmatic, crossover, randomized controlled study evaluates the efficacy of virtual reality assisted physical therapy (VRPT) for improving the physical activity of hospitalized children as compared to traditional physical therapy. This is a pilot study that will be used to identify patient populations that can benefit the most from VRPT and estimate this effect for future studies. Patients with a significant neurological condition, major developmental disability, active infection of the face or hand, history of severe motion sickness, history of seizures caused by flashing light or had a major surgery within the last 48 hours will be excluded.

Research Team

Thomas Caruso

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for hospitalized children and young adults aged 7-25 who need physical therapy and will stay in the hospital for at least two more days. It's not for those with serious neurological issues, developmental disabilities, infections on their face or hand, severe motion sickness, a history of seizures triggered by flashing lights, or recent major surgery.

Inclusion Criteria

I am between 7 and 25 years old.

I am currently seeing a physical therapist.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Virtual Reality assisted Physical Therapy (VRPT) and traditional Physical Therapy (PT) sessions in a crossover design

6 weeks

Multiple sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Traditional Physical Therapy
• Virtual Reality Physical Therapy

Trial Overview The study compares virtual reality-assisted physical therapy (VRPT) to traditional methods to see which improves physical activity more in hospitalized kids. Participants are randomly chosen to start with one type of therapy and then switch to the other.

Participant Groups

Group I: 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.

Group II: 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 Virtual Reality assisted Physical Therapy sessions (VRPT) in the second Physical Therapy session under the supervision of the accredited physical therapist.

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

Approved in United States as Physical Therapy for:

• Knee pain due to osteoarthritis
• Musculoskeletal injuries and conditions
• Postoperative rehabilitation
• Chronic conditions affecting bones, muscles, joints, ligaments, and tendons

Approved in European Union as Physical Therapy for:

• Musculoskeletal injuries and conditions
• Postoperative rehabilitation
• Chronic conditions affecting bones, muscles, joints, ligaments, and tendons
• Neurological disorders like stroke, Parkinson’s disease, spinal cord injuries, and multiple sclerosis

Approved in Canada as Physical Therapy for:

• Knee pain due to osteoarthritis
• Musculoskeletal injuries and conditions
• Postoperative rehabilitation
• Chronic conditions affecting bones, muscles, joints, ligaments, and tendons

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

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 study involving 29 children with cerebral palsy showed that virtual reality-based training (VRBT) significantly improved balance and manual ability compared to traditional rehabilitation methods, with notable improvements in the study group for participation, motivation, cooperation, and satisfaction.

This research is pioneering in exploring VRBT for postoperative rehabilitation in children with cerebral palsy, indicating its potential as an effective therapeutic tool, although further studies with larger sample sizes are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality based therapy for post operative rehabilitation of children with cerebral palsy. Sharan, D., Ajeesh, PS., Rameshkumar, R., et al.[2012]

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]

The INOVATE-Pain consortium, consisting of 16 experts, aims to improve the use of virtual reality (VR) and augmented reality (AR) in treating pediatric chronic pain by establishing best practices for designing and evaluating these interventions.

Key recommendations include fostering partnerships among stakeholders, standardizing outcome measures for evaluation, and ensuring access to resources, all of which are essential for developing effective VR-based pain management solutions for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management. Logan, DE., Simons, LE., Caruso, TJ., et al.[2021]

References

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

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality based therapy for post operative rehabilitation of children with cerebral palsy. [2012]

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

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

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

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

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Playing your pain away: designing a virtual reality physical therapy for children with upper limb motor impairment. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The efficacy of virtual reality interventions compared with conventional physiotherapy in improving the upper limb motor function of children with cerebral palsy: a systematic review of randomised controlled trials. [2023]