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

Trial Summary

What is the purpose of this trial?

The primary objective of this pilot randomized controlled trial (RCT) is to test the feasibility (recruitment rate, retention rate, participant burden, adherence, technical issues, safety) and usability (system usability scale, SUS) of Omnidirectional treadmill Virtual Reality training (omni-VR) among chronic stroke survivors. Our secondary objective is to (1) estimate the extent to which cognition, brain activation during a dual task activity, walking ability, and dynamic balance change after 3 months of training among intervention participants (omni-VR) and traditional exercise controls, and (2) estimate the extent to which health-related quality of life and motivation co-evolve with our secondary outcomes. Researchers will compare the intervention group and control group to evaluate the impact of omni-VR on cognition and physical function among stroke survivors. Participants will: * undergo a 45-minute training session 3 times per week for 12 weeks * intervention group: omni-VR * control group: traditional exercise program (strengthening and walking activities)

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 data supports the effectiveness of the treatment Omnidirectional Virtual Reality and Treadmill Training for stroke?

Research shows that virtual reality (VR) can help in stroke rehabilitation by improving physical and psychological recovery. Studies have found that VR-based therapies can enhance neural plasticity (the brain's ability to adapt and change) and aid in upper limb recovery, suggesting potential benefits for stroke patients. ^{1 2 3 4 5}

Is virtual reality and treadmill training safe for stroke rehabilitation?

Virtual reality and treadmill training appear to be generally safe for stroke rehabilitation, with no serious adverse events reported. Some participants experienced dizziness, but overall satisfaction and adherence were high. ^{6 7 8 9 10}

How is the treatment 'Omnidirectional Virtual Reality and Treadmill Training' unique for stroke rehabilitation?

This treatment is unique because it combines virtual reality (VR) with treadmill training to create an immersive environment that enhances motor learning and functional recovery after a stroke. VR provides task-specific training and multimodal feedback, which can help improve movement skills and transfer them to real-world tasks, potentially offering advantages over traditional rehabilitation methods. ^{1 3 4 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The Use of the Term Virtual Reality in Post-Stroke Rehabilitation: A Scoping Review and Commentary. [2023]

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

Computer-Mediated Therapies for Stroke Rehabilitation: A Systematic Review and Meta-Analysis. [2022]

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

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

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

Effects of Virtual Reality Intervention on Neural Plasticity in Stroke Rehabilitation: A Systematic Review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of a Virtual Reality Commercial Gaming Device in Upper Limb Recovery after Stroke: A Randomized, Controlled Study. [2019]

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

Safety and Feasibility of a First-Person View, Full-Body Interaction Game for Telerehabilitation Post-Stroke. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality during Robot-Assisted Gait Training: Validation of a New Device in Stroke Rehabilitation. [2023]

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

Effectiveness and safety of virtual reality rehabilitation after stroke: an overview of systematic reviews. [2023]

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

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

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

Potential of the omnidirectional walking platform with virtual reality as a rehabilitation tool. [2023]

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

Virtual environments for motor rehabilitation: review. [2022]

12. England 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. [2023]