Virtual Reality Therapy for Stroke Recovery

Recruiting at 1 trial location

Overseen By Andréanne Blanchette, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Walking, visual perception, exercise clearance

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) can help stroke survivors improve their walking skills in real-world settings. Participants will use VR goggles and game controllers to navigate a simulated shopping mall and surrounding streets. The goal is to determine if this approach, known as Virtual Reality and Field Training (VRFT), is safe, well-received, and effective for those who have difficulty walking after a stroke. Ideal participants are stroke survivors who still struggle with walking, have mild movement limitations, and can walk for at least one minute with or without a walking aid. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance rehabilitation techniques for stroke survivors.

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 prior data suggests that this virtual reality therapy is safe for stroke recovery?

Research has shown that virtual reality (VR) therapy offers a safe and effective method for stroke recovery. Studies have found that VR therapy enhances balance, movement, and the ability to perform everyday tasks in stroke survivors. Specifically, a review of 16 studies with 496 participants revealed that VR therapy significantly improved leg movement compared to those who did not use VR.

The engaging nature of VR keeps patients interested and motivated during recovery, making it both helpful and enjoyable. These studies have reported no serious side effects, indicating that most people tolerate VR well. Overall, VR therapy appears to be a promising and safe option for improving stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality and Field Training (VRFT) for stroke recovery because it offers a unique, immersive experience that standard physical therapy options don't provide. Unlike traditional methods, which often involve repetitive physical exercises, VRFT uses virtual reality to simulate real-world environments, making rehabilitation more engaging and motivating. This approach not only enhances the patient's ability to perform daily tasks but also has the potential to accelerate recovery by making therapy sessions more enjoyable and personalized. By integrating cutting-edge technology, VRFT could bring a fresh and dynamic element to stroke rehabilitation, aiming to improve outcomes in a shorter time frame.

What evidence suggests that Virtual Reality and Field Training is effective for stroke recovery?

Research has shown that virtual reality (VR) can significantly aid stroke recovery, particularly in enhancing movement and balance. Studies have found benefits for both arm and leg recovery, as well as walking speed and balance. VR engages and motivates patients, encouraging them to persist with therapy. Previous patients demonstrated significant improvements in physical abilities after using VR for rehabilitation. In this trial, participants will engage in Virtual Reality and Field Practice Training (VRFT), which combines VR with real-world practice, potentially helping stroke survivors walk better in their communities. ^{1 3 6 7 8}

Who Is on the Research Team?

Anouk Lamontagne, PhD

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

This trial is for chronic stroke survivors aged 40-74 with walking, cognitive, or visual-perceptual deficits. They must have had their first-ever unilateral stroke 9-24 months prior and be able to walk independently at a certain speed. Participants need normal vision/hearing (with aids if necessary) and mild-to-moderate hemiparesis.

Inclusion Criteria

I have long-term effects from a stroke affecting my walking, vision, or thinking.

Your ability to see and understand things is mostly normal or only slightly affected.

I can walk on my own with or without help for at least 1 minute.

Exclusion Criteria

You have other health conditions that affect your ability to see.

You haven't been given permission by a doctor to exercise.

I have health conditions that make it hard for me to walk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention Assessment

Participants are assessed on measures of functional walking, balance, and mobility before the intervention

4 weeks

2 visits (in-person)

Treatment

Participants engage in a 4-week VR and field training program, including VR sessions in a clinical setting and community ambulation practice

4 weeks

3 visits (in-person) per week for VR, 2 supervised sessions per week for field training

Post-intervention Assessment

Participants are assessed immediately after the intervention on various outcome measures

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality and Field Training (VRFT)

Trial Overview The study tests a new intervention combining virtual reality (VR) and field training aimed at improving community walking skills in stroke survivors. It involves VR exercises in a simulated environment and supervised outdoor walking practice over a four-week program.

How Is the Trial Designed?

Group I: Virtual Reality and Field Practice Training (VRFT) Experimental Treatment 1 Intervention

Participants will engage in a 4-week VRFT intervention that comprises of 1-hour training sessions, 3 times/week.

Virtual Reality and Field Training (VRFT) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Virtual Reality Therapy for:

• Stroke rehabilitation
• Motor re-learning
• Balance and gait recovery

Approved in United States as Virtual Reality Rehabilitation for:

• Stroke rehabilitation
• Cognitive and motor recovery
• Community ambulation skills

Approved in Canada as Virtual Environment Training for:

• Stroke rehabilitation
• Balance and gait recovery
• Neuroplasticity enhancement

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

Jewish Rehabilitation Hospital

Collaborator

Trials

7

Recruited

810+

Laval University

Collaborator

Trials

439

Recruited

178,000+

Integrated University Health and Social Services Center of the Capitale-Nationale

Collaborator

Trials

5

Recruited

580+

Published Research Related to This Trial

Patients with upper limb motor impairments who participated in virtual reality (VR) training were significantly more active during sessions, with an activity rate of 77.6% compared to 67.3% in conventional task-oriented training (CT).

This increased activity was particularly notable in patients with severe motor impairments, suggesting that VR training may enhance engagement and potentially improve recovery outcomes, although further results from the VIRTUES trial are needed to confirm this effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is upper limb virtual reality training more intensive than conventional training for patients in the subacute phase after stroke? An analysis of treatment intensity and content. Brunner, I., Skouen, JS., Hofstad, H., et al.[2022]

A meta-meta-analysis of 10 studies involving nearly 550 stroke patients found that virtual reality (VR) training significantly improves upper limb function and balance, with effect sizes indicating strong benefits (SMD 4.606 for upper limb function and SMD 2.101 for balance).

Despite the positive results, the analysis revealed considerable heterogeneity among the studies, suggesting that the findings should be interpreted with caution and indicating a need for further research, particularly regarding the impact of VR on walking ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Virtual Reality Training on Upper Limb Function and Balance in Stroke Patients: Systematic Review and Meta-Meta-Analysis. Wu, J., Zeng, A., Chen, Z., et al.[2021]

Virtual reality therapy (VRT) has been shown to safely enhance motor and functional recovery in stroke patients, improving upper limb function, gait, balance, and quality of life when used alongside conventional therapy.

While VRT demonstrates significant benefits, it does not show clear superiority over traditional rehabilitation methods, indicating a need for further research to identify which patients respond best to this therapy and to establish optimal treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current evidence on virtual reality and its potential usefulness in post-stroke neurorehabilitation]. León-Ruiz, M., Pérez-Nieves, MT., Arce-Arce, S., et al.[2020]

This feasibility trial involves 40 stroke patients to assess the use of home-based virtual reality training (VRT) for rehabilitation, focusing on improving arm function, balance, and walking after discharge from inpatient care.

The study aims to evaluate the practicality of VRT in a home setting, including participant recruitment, technology handling, compliance, and perceived effectiveness, which could pave the way for a larger trial on its efficacy in stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based virtual reality training after discharge from hospital-based stroke rehabilitation: a parallel randomized feasibility trial. Sheehy, L., Taillon-Hobson, A., Sveistrup, H., et al.[2020]

In a study involving 76 stroke rehabilitation inpatients, virtual reality training (VRT) for sitting balance did not show significant improvements compared to a control group, indicating that VRT may not be effective for enhancing sitting balance after stroke.

Both groups demonstrated similar outcomes in sitting balance and upper extremity function, suggesting that more challenging exercises and higher treatment intensity are needed in future research to better assess the efficacy of VRT in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sitting Balance Exercise Performed Using Virtual Reality Training on a Stroke Rehabilitation Inpatient Service: A Randomized Controlled Study. Sheehy, L., Taillon-Hobson, A., Sveistrup, H., et al.[2021]

A systematic review of 21 randomized controlled trials found that virtual reality (VR) training significantly improves balance and gait recovery in stroke patients compared to conventional training methods.

VR training was particularly effective when combined with traditional therapy, showing better results in measures like gait speed and balance tests, suggesting it could be a valuable addition to rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality Training on Balance and Gait Ability in Patients With Stroke: Systematic Review and Meta-Analysis. de Rooij, IJ., van de Port, IG., Meijer, JG.[2022]

The pilot study aims to assess the feasibility and tolerability of a therapeutic virtual reality (VR) platform in inpatient stroke rehabilitation, focusing on its potential to enhance upper extremity recovery and pain management for veterans over a 4-6 week period.

Preliminary findings suggest that VR interventions could provide effective adjunct therapy in stroke rehabilitation, with the potential for seamless transition from hospital to home, thereby improving patient engagement in self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality to Improve Outcomes in Veterans With Stroke: Protocol for a Single-Arm Pilot Study. Tran, JE., Fowler, CA., Delikat, J., et al.[2021]

A meta-analysis of 27 studies found that virtual reality (VR) therapy significantly improves upper limb (UL) function, activity, and participation in stroke patients compared to conventional therapies, with notable improvements in specific tests like the Fugl-Meyer Upper Extremity and Box and Block Test.

The results suggest that VR is a promising and effective rehabilitation tool for enhancing motor recovery in stroke patients, indicating its potential as a valuable addition to traditional therapy methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality therapy for upper limb rehabilitation in patients with stroke: a meta-analysis of randomized clinical trials. Mekbib, DB., Han, J., Zhang, L., et al.[2021]

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]

Citations

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Virtual reality in stroke recovery: a meta-review of systematic ... Evidence from high-quality systematic reviews suggests that there is benefit from VR in upper limb, lower limb, gait, and balance recovery.

2. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01641-9

Patient-centered insights into virtual reality rehabilitation for ... Most stroke survivors experienced significant improvements in physical function after participating in VR rehabilitation training. This ...

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Review Rehabilitation applied with virtual reality improves ... The aim of this study was to systematically explore the effects of VR rehabilitation program on functional capacity of stroke patients. We conducted a ...

4. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD008349.pub5/full

Virtual reality for stroke rehabilitation - Laver, KE - 2025 Outcomes. The critical outcome of interest was upper limb function and activity. Important outcomes included mobility outcomes (gait speed, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10836287/

Exploring the efficacy of virtual reality-based rehabilitation ... VRBR holds promise as an efficacious intervention in stroke rehabilitation. Its immersive nature enhances patient engagement and motivation.

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Virtual reality in stroke recovery: a meta-review of systematic ... Evidence from high-quality systematic reviews suggests that there is benefit from VR in upper limb, lower limb, gait, and balance recovery.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2667032125000149

Virtual reality-based robotic training for lower limb ... The VR-based robotic training for lower limb rehabilitation showed promise in improving motor function, activities of daily living, and quality of life in ...

8. jmir.org jmir.org/2025/1/e72364

Effect of Virtual Reality–Based Therapies on Lower Limb ... Meta-analysis of 16 studies (496 participants) showed VR therapy significantly improved lower limb mobility in patients with stroke compared to ...