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

40 Participants Needed

Trial Summary

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 Virtual Reality guided motor rehabilitation for stroke?

Research shows that virtual reality rehabilitation can be as effective as traditional physical therapy in helping stroke patients regain movement in their arms. Studies have found that using virtual reality systems, like gaming devices, can improve recovery in stroke patients by making therapy more engaging and motivating. ^{1 2 3 4 5}

Is virtual reality rehabilitation safe for stroke patients?

Most studies on virtual reality rehabilitation for stroke do not focus on safety, but a few reviews have reported some adverse effects. Overall, the evidence on safety is limited, and more high-quality studies are needed to better understand any potential risks. ^{4 6 7 8 9}

How does virtual reality guided motor rehabilitation differ from other stroke treatments?

Virtual reality guided motor rehabilitation is unique because it uses computer-generated environments to help stroke patients practice movements, which can improve their ability to perform real-world tasks. Unlike traditional therapies, VR can provide immersive and engaging experiences that may enhance motivation and learning, and studies suggest it can be more effective than conventional training in some cases. ^{2 3 4 10 11}

What is the purpose of this trial?

The goal of this clinical trial is to test whether a low-cost virtual reality (VR) motor rehabilitation platform can improve motor recovery in people recovering from a first-time ischemic stroke both in the hospital and at home. The study focuses on adults aged 18 and older who have experienced moderate to severe upper limb motor deficits. The main questions it aims to answer are: * Can VR-based motor therapy improve upper limb motor function compared to standard care? * Is VR-based motor therapy a feasible and acceptable treatment option for stroke patients? Researchers will compare patients receiving VR therapy to those receiving standard care to see if the VR therapy leads to greater improvements in motor recovery and more positive patient experiences. Participants will: * Complete standardized assessments of motor function and quality of life at multiple time points. * Participate in VR therapy sessions (if in the treatment group), using gamified activities designed to improve upper limb movement. * Provide feedback on their experience with the VR system, including ease of use, motion sickness, and engagement. This study will help determine whether VR-based rehabilitation can be a practical, effective way to improve access to therapy and recovery outcomes for stroke patients, especially in rural settings with limited rehabilitation resources.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

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

Virtual Reality Training for Upper Extremity in Subacute Stroke (VIRTUES): A multicenter RCT. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

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. Germany pubmed.ncbi.nlm.nih.gov

Virtual reality in the rehabilitation of patients with stroke: an integrative review. [2020]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England 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. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality in Neurorehabilitation: An Umbrella Review of Meta-Analyses. [2021]

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

Virtual environments for motor rehabilitation: review. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Can specific virtual reality combined with conventional rehabilitation improve poststroke hand motor function? A randomized clinical trial. [2023]