Virtual Reality and Treadmill Training for Stroke

(PROVE Trial)

Overseen By Adria Quigley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Visual deficits, Cardiovascular, Orthopedic, Neurological, others

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

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to improve thinking skills and walking ability in stroke survivors. One group will use virtual reality combined with a special treadmill (omnidirectional virtual reality and treadmill training), while the other group will perform traditional exercises. The researchers aim to determine if the virtual reality method can more effectively enhance balance, walking, and overall quality of life. Individuals who had a stroke more than six months ago and have difficulty walking may be suitable for this trial. Participants should live near Halifax, Nova Scotia, and be able to exercise for at least 15 minutes without major health or vision issues affecting walking.

As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation methods that could enhance recovery and quality of life.

Will I have to stop taking my current medications?

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 prior data suggests that this virtual reality and treadmill training is safe for stroke survivors?

Research has shown that using virtual reality with treadmill exercises is generally safe and well-received. Studies with similar setups have found that stroke survivors often walk faster and feel more motivated, with no major side effects. Although detailed safety data from large groups is lacking, virtual reality has shown promise in addressing various health issues. This suggests it could be safe for stroke recovery as well. Before joining a trial, discussing potential risks and benefits with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using omnidirectional virtual reality and treadmill training for stroke rehabilitation because it offers a new, immersive way to engage patients. Unlike traditional physiotherapy that typically involves repetitive, unidirectional treadmill exercises, this method uses virtual environments to simulate real-world scenarios, which could enhance motor learning and engagement. Additionally, the ability to move in multiple directions can better mimic everyday activities, potentially leading to more effective recovery of mobility and coordination for stroke survivors.

What evidence suggests that this trial's treatments could be effective for stroke survivors?

Research has shown that virtual reality (VR) can aid stroke survivors by enhancing both physical abilities and mental well-being. Studies have found that VR therapy significantly increases walking speed and distance, as well as overall movement. It also boosts motivation and supports neuroplasticity, which aids recovery. In this trial, participants in the Omni-VR group will train using omnidirectional virtual reality and treadmill training, which has proven especially effective for those more than six months post-stroke. This suggests that VR and treadmill training could be a promising method for stroke recovery. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for chronic stroke survivors who had a stroke at least 6 months ago, can walk with minimal assistance, have walking limitations, moderate or severe cognitive impairment but can still exercise for at least 15 minutes. They must live near Halifax and not have other health issues affecting balance or vision.

Inclusion Criteria

I live within 50 km of Halifax, Nova Scotia.

I do not have vision loss or ignore one side of my body.

I can exercise for 15 minutes or more.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 45-minute training sessions 3 times per week for 12 weeks using either omnidirectional virtual reality and treadmill training or traditional exercise program

12 weeks

36 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omnidirectional Virtual Reality and Treadmill Training

Trial Overview

The study tests if using Omnidirectional Virtual Reality (omni-VR) on a treadmill helps improve cognition, brain function during multitasking, walking ability, and balance in chronic stroke patients compared to traditional exercises. Participants will train three times weekly for three months.

How Is the Trial Designed?

Group I: Omni-VR group Experimental Treatment 1 Intervention

20 participants will undergo 45-minute training sessions 3 times per week for 12 weeks using omnidirectional virtual reality and treadmill training.

Group II: Control group Active Control 1 Intervention

10 participants will undergo 45-minute traditional physiotherapy training sessions including lower limb strengthening and unidirectional treadmill training 3 times per week for 12 weeks.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Brain Canada

Collaborator

Trials

22

Recruited

6,100+

Published Research Related to This Trial

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]

In a study involving 105 stroke patients, both Nintendo Wii gaming and conventional therapy did not show significant improvements in upper limb recovery compared to a control group after 12 sessions over 3 weeks.

The primary outcome measure, the Fugl-Meyer assessment, and secondary measures indicated no differences in recovery outcomes among the three groups at the end of the intervention or at follow-up periods of 4 and 8 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Virtual Reality Commercial Gaming Device in Upper Limb Recovery after Stroke: A Randomized, Controlled Study. Kong, KH., Loh, YJ., Thia, E., et al.[2019]

Virtual reality (VR) interventions, when combined with conventional therapy, appear to be more effective than conventional therapy alone for improving upper limb function in stroke patients, based on an overview of 58 systematic reviews involving 345 unique studies.

Despite the promising results for upper limb function, the overall methodological quality of the reviews was low, indicating that while VR shows potential, clinicians should be cautious and consider individual patient needs and preferences when integrating VR into rehabilitation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of virtual reality rehabilitation after stroke: an overview of systematic reviews. Bargeri, S., Scalea, S., Agosta, F., et al.[2023]

The study tested the safety of using Microsoft Kinect® with Oculus Rift® for telerehabilitation in 14 participants without disabilities and 5 post-stroke individuals, finding no significant adverse events overall.

While the technology was safe for most, participants post-stroke required significant physical support for balance, which limits its practical application in telerehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of a First-Person View, Full-Body Interaction Game for Telerehabilitation Post-Stroke. Proffitt, R., Warren, J., Lange, B., et al.[2020]

A new fully immersive virtual reality (VR) application for robot-assisted gait training (RAGT) was tested on 37 healthy participants, showing high usability and a low incidence of cybersickness, with 78.4% reporting no significant adverse effects.

Participants experienced a strong sense of presence in the virtual environment, indicating that the VR device is engaging and could potentially enhance rehabilitation for non-ambulatory stroke patients in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality during Robot-Assisted Gait Training: Validation of a New Device in Stroke Rehabilitation. Morizio, C., Compagnat, M., Boujut, A., et al.[2023]

A review of 121 papers on virtual reality (VR) for post-stroke rehabilitation found that only 64% explicitly defined VR, highlighting a need for consistent terminology in the field.

The study developed a new taxonomy categorizing 16 mixed reality systems based on display type, information mixing, and input devices, which could improve communication and understanding of the efficacy and feasibility of different VR rehabilitation systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of the Term Virtual Reality in Post-Stroke Rehabilitation: A Scoping Review and Commentary. Huygelier, H., Mattheus, E., Abeele, VV., et al.[2023]

A systematic review of 27 studies involving 232 stroke survivors found that virtual reality (VR) rehabilitation significantly improves neural plasticity, evidenced by enhanced cortical connectivity and increased cortical mapping of affected limb muscles.

The improvements in neural plasticity were positively correlated with better functional recovery, suggesting that VR interventions can effectively aid in stroke rehabilitation by promoting brain changes that support recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Virtual Reality Intervention on Neural Plasticity in Stroke Rehabilitation: A Systematic Review. Hao, J., Xie, H., Harp, K., et al.[2022]

Individuals with disabilities can effectively learn motor skills in virtual reality environments, which can translate to real-world tasks and even improve untrained skills.

Clinical studies indicate that virtual reality training may offer advantages over traditional motor learning methods, with no reported cases of cybersickness in patients using VR for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual environments for motor rehabilitation: review. Holden, MK.[2022]

A preliminary study involving 35 participants found that using virtual reality with an omnidirectional walking platform (ODWP) for rehabilitation is perceived as relatively safe (mean score of 78.9/100) and has moderate acceptance (64.5/100).

However, 71% of participants reported experiencing mild to moderate cybersickness, indicating that while the technology shows promise, further improvements are needed to enhance user comfort and acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential of the omnidirectional walking platform with virtual reality as a rehabilitation tool. Soon, B., Lee, N., Lau, J., et al.[2023]

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]

Virtual reality (VR) is a feasible intervention for stroke rehabilitation within one month after a stroke, as confirmed by a systematic review of 17 high-quality randomized controlled trials.

While VR shows promise, the meta-analysis indicated that it does not significantly outperform conventional rehabilitation methods in improving upper extremity function, daily living activities, balance, or cognition in early-stage stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of virtual reality in the early-stage stroke rehabilitation: A systematic review and meta-analysis of randomized controlled trials. Hao, J., Yao, Z., Harp, K., et al.[2023]

Immersive virtual reality (IVR) treatments showed comparable improvements in upper limb activity and daily functioning in stroke patients when compared to conventional therapy (CT), indicating its potential as an effective rehabilitation tool.

Non-immersive virtual reality (NIVR) also provided similar benefits to CT for various physical and psychological outcomes, but IVR may offer additional advantages for upper limb training, suggesting that the type of VR used can influence treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Mediated Therapies for Stroke Rehabilitation: A Systematic Review and Meta-Analysis. Mugisha, S., Job, M., Zoppi, M., et al.[2022]

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