Virtual Reality Rehabilitation for Stroke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Brainstem stroke, Parkinson's, Apraxia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 47 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) can enhance arm movement recovery after a stroke. It compares VR-based therapy with usual care to determine which improves arm function more effectively and assesses if patients find VR easy and enjoyable. The trial seeks individuals who have experienced a first-time stroke and face challenges in arm movement. Participants will receive either standard care or engage in VR activities and provide feedback on their experience. This research aims to determine if VR can make stroke rehabilitation more accessible, particularly for those in areas with limited therapy options. As an unphased trial, this study offers participants the chance to contribute to innovative research that could transform stroke rehabilitation.

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 rehabilitation is safe for stroke patients?

Research has shown that virtual reality (VR) rehabilitation is generally safe for stroke patients. Studies have found that VR-based therapies are as safe as, or even better than, traditional therapy methods. For example, a review of several studies found that stroke survivors often find VR therapy easy to use and engaging. This means that people using VR for rehabilitation usually don't face major safety issues or discomfort.

One study found that fully immersive VR applications were suitable for stroke rehabilitation, suggesting that the technology can be used without causing significant negative effects. Moreover, stroke survivors have reported positive experiences with VR, indicating its safety and acceptability as part of their recovery.

Overall, VR rehabilitation is well-tolerated by patients and has not been linked to serious negative events. This makes it a promising option for stroke patients seeking effective and safe rehabilitation methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about virtual reality rehabilitation for stroke because it offers a new way to enhance motor recovery. Unlike traditional therapies, which often involve standard physical exercises, this method uses immersive virtual environments to engage patients actively. The use of a virtual reality headset provides an interactive and engaging experience, potentially improving motivation and consistency in rehabilitation exercises. This innovative approach could lead to better outcomes by making rehabilitation more enjoyable and accessible, even at home.

What evidence suggests that virtual reality rehabilitation is effective for stroke recovery?

This trial will compare Virtual Reality (VR) guided motor rehabilitation with standard care for stroke patients. Studies have shown that VR can significantly aid stroke patients in regaining movement skills. Research indicates that VR therapy enhances arm and hand movement more effectively than traditional care. One study found that VR not only aids in movement recovery but also improves cognitive skills and mental health. Another review concluded that VR serves as a useful and flexible addition to regular stroke rehabilitation. These findings suggest that VR therapy could be a practical and effective method to enhance recovery for stroke patients, especially when traditional rehab is difficult to access. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who've had their first ischemic stroke and are dealing with moderate to severe upper limb motor deficits. It's designed to help those in the hospital or at home, especially in rural areas with few rehab resources. People can't join if they don't meet specific health conditions set by the researchers.

Inclusion Criteria

Score between 6 and 40 on Fugl-Meyer Assessment's Upper Limb Extremity Subscore (FM - UE), indicating moderate to severe motor deficit

I can understand and agree to the study, or someone legally authorized can consent for me.

INPATIENT ARM: Less than 5 weeks since stroke onset with admission to Valley Regional Hospital in Kentville, NS, Canada

Exclusion Criteria

I have a neurological condition like Parkinson's disease.

Apraxia as identified by clinical assessment

I have had a stroke affecting my brainstem, cerebellum, or both sides of my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VR-based motor therapy or standard care for motor recovery both in the hospital and at home

47 days

Multiple sessions both in-person and at home

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Extension

Participants may continue VR therapy independently if they meet certain criteria

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality guided motor rehabilitation

Trial Overview Researchers are testing a low-cost VR system that guides patients through games aimed at improving arm movement after a stroke. They want to see if it's better than standard care and if patients find it doable and like using it.

How Is the Trial Designed?

Group I: In Hospital - Virtual Reality Rehabilitation Experimental Treatment 1 Intervention

Inpatient supplementary rehabilitation delivered through a virtual reality headset

Group II: At Home - Virtual Reality Rehabilitation Experimental Treatment 1 Intervention

Outpatient supplementary rehabilitation delivered through a virtual reality headset

Group III: In Hospital - Standard of Care Active Control 1 Intervention

Inpatient standard of care for acute stroke

Group IV: At Home - Standard of care Active Control 1 Intervention

Outpatient standard of care for acute stroke

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Acadia University

Collaborator

Trials

4

Recruited

270+

Published Research Related to This Trial

In a study involving 120 stroke patients, upper extremity virtual reality (VR) rehabilitation training was found to be equally effective as conventional training (CT) in improving motor function, with no significant differences in outcomes measured by the Action Research Arm Test (ARAT).

Both VR and CT groups showed similar improvements in upper extremity function after 16 sessions over 4 weeks, suggesting that while VR is a motivating alternative, it does not provide additional benefits over traditional rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Training for Upper Extremity in Subacute Stroke (VIRTUES): A multicenter RCT. Brunner, I., Skouen, JS., Hofstad, H., et al.[2022]

RehabMaster™, a virtual reality system designed for post-stroke rehabilitation, was found to be safe and feasible, showing significant improvements in upper extremity function as measured by the Fugl-Meyer Assessment (FMA) and modified Barthel Index (MBI) in a clinical trial with seven chronic stroke patients.

In a randomized controlled trial with 16 acute or subacute stroke patients, adding RehabMaster to conventional occupational therapy showed a trend towards greater improvement in FMA scores, indicating its potential to enhance rehabilitation outcomes, although it did not significantly affect MBI scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A task-specific interactive game-based virtual reality rehabilitation system for patients with stroke: a usability test and two clinical experiments. Shin, JH., Ryu, H., Jang, SH.[2021]

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]

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]

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) rehabilitation significantly improved upper limb motor function in chronic stroke patients compared to their pre-treatment scores, with a moderate effect size (SMD = 0.28).

VR interventions were found to be as effective as conventional physical therapy, showing no statistically significant difference in outcomes, indicating that both methods can be beneficial for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality-based rehabilitation versus conventional therapy on upper limb motor function of chronic stroke patients: a systematic review and meta-analysis of randomized controlled trials. Al-Whaibi, RM., Al-Jadid, MS., ElSerougy, HR., et al.[2022]

Using commercial video games like the Nintendo Wii® in virtual reality rehabilitation for stroke patients showed significant improvements in dynamic balance, upper limb motor function, and quality of life, based on an integrative review of 13 studies involving 5-47 participants each.

The virtual reality interventions were found to be more effective than conventional treatments specifically for improving dynamic balance, although some studies did not report changes in static balance or daily living activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality in the rehabilitation of patients with stroke: an integrative review. Aramaki, AL., Sampaio, RF., Reis, ACS., et al.[2020]

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]

An umbrella review of 41 meta-analyses found mostly low- to very low-quality evidence supporting the effectiveness of virtual reality (VR) interventions in the rehabilitation of patients with neurological disorders, such as stroke and cerebral palsy.

Despite the potential benefits of VR for improving functions like ambulation in children with cerebral palsy and mobility in stroke patients, most studies did not adequately address safety concerns, highlighting the need for high-quality randomized controlled trials to establish robust evidence and guidelines for VR rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality in Neurorehabilitation: An Umbrella Review of Meta-Analyses. Voinescu, A., Sui, J., Stanton Fraser, D.[2021]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8131676/

Effectiveness of Virtual Reality in the Rehabilitation of Motor ... We conducted this meta-analysis to determine the efficacy of VR, compared to CT, in restoring motor function in this patient population.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0048712025000271

Review Rehabilitation applied with virtual reality improves ... Virtual reality in stroke rehabilitation: a systematic review of its effectiveness for upper limb motor recovery. Top Stroke Rehabil, 14 (2007), pp. 52-61.

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

Patient-centered insights into virtual reality rehabilitation for ... Research has already shown that VRR can effectively enhance patients' motor function, cognitive abilities, and psychological well-being [13,14, ...

4. frontiersin.org frontiersin.org/journals/virtual-reality/articles/10.3389/frvir.2025.1653968/full

A systematic review on the use of virtual reality in post- ... Conclusion: VR is an effective and versatile adjunct to conventional stroke rehabilitation, with SI-VR showing the most consistent motor benefits and immersive ...

5. signavitae.com signavitae.com/articles/10.22514/sv.2025.096

Meta-analysis on the impact of virtual reality technology ... As an emerging rehabilitation intervention, VR technology can effectively promote the recovery of motor function in stroke patients and significantly improve ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10514431/

Effectiveness and safety of virtual reality rehabilitation after ... Systematic reviews of VR-based post-stroke interventions have shown that VR made be superior to23, 24, 25 or equal to, conventional therapy, engendering ...

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0313296

A protocol for systematic review and meta-analysis | PLOS One Virtual reality (VR)-based rehabilitation holds potential for enhancing rehabilitation intensity and engagement by stimulating tasks. While ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2324242624000421

Virtual reality as a non-conventional rehabilitation for stroke Our findings show that VR based rehabilitations can be beneficial in restoring post-stroke upper limb functions and improving routine life of survivors.