Virtual Reality Therapy for Stroke

Overseen By Ruth Reinsel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stony Brook University

Disqualifiers: Plegia, Vertigo, Epilepsy, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

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: 1

Duration: 5 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

Use the template below as a guide to write a brief study description in plain language. Tailor the text that appears in brackets and yellow to your research study. To finalize, delete the text in italics. The goal of this single-arm study is to explore the use of early virtual reality-based rehabilitation as an adjunct to conventional physical/occupational therapy in adult patients with acute ischemic stroke. The main question it aims to answer is: Feasibility and tolerability of using immersive Virtual Reality technology-based therapy for patients suffering from acute ischemic stroke in an inpatient hospital setting Participants will receive 1 or 2 virtual reality therapy sessions and complete surveys at the end of each session.

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 Based Rehabilitation (VRBR) for stroke?

Research shows that virtual reality therapy can help stroke patients improve their movement and daily activities by providing engaging exercises that enhance brain recovery. Studies have found that virtual reality-based rehabilitation can be more effective than standard therapy for improving walking speed, balance, and mobility after a stroke. ^{1 2 3 4 5}

Is virtual reality therapy safe for stroke rehabilitation?

Virtual reality therapy has been studied for stroke rehabilitation and is generally considered safe for use in humans, with no major safety concerns reported in the research. ^{2 6 7 8 9}

How is virtual reality therapy different from other stroke treatments?

Virtual reality therapy for stroke is unique because it uses immersive technology to create a simulated environment that engages multiple senses, enhancing motor, cognitive, and psychological recovery. Unlike traditional therapies, it provides real-time feedback and task-specific training, which can drive brain plasticity and improve functional recovery. ^{2 6 7 10 11}

Research Team

Jason Mathew, MD

Principal Investigator

Stony Brook University Hospital

Eligibility Criteria

This trial is for adults who have recently had an ischemic stroke and are currently in the hospital. They should be able to participate in physical or occupational therapy sessions and willing to try virtual reality-based exercises.

Inclusion Criteria

I am older than 18 years.

MRI or CT imaging confirmed ischemic stroke

I can understand and follow complex instructions.

Exclusion Criteria

Pregnant patients

Patients with a pre-existing condition that interferes with virtual reality usage (e.g., visual impairment, limitation of either upper extremity or neck)

I have epilepsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 1 or 2 virtual reality therapy sessions as an adjunct to conventional therapy

5 weeks

1-2 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Virtual Reality Based Rehabilitation

Trial Overview The study is testing how feasible and tolerable it is for patients with acute ischemic stroke to use immersive Virtual Reality (VR) as part of their rehabilitation while they're still hospitalized.

Participant Groups

Group I: Virtual Reality Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

Good Samaritan Hospital

Collaborator

Trials

2

Recruited

170+

Findings from Research

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]

The Rapael Smart Board™ (SB) showed significant improvements in upper limb function for stroke survivors, particularly in shoulder abduction and internal rotation, when compared to conventional therapy, indicating its efficacy as a rehabilitation tool.

The study demonstrated that the SB not only enhances functional outcomes but also correlates well with clinical assessments of upper limb ability, suggesting it can be a valuable tool for both rehabilitation and evaluation in stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of virtual reality-based planar motion exercises on upper extremity function, range of motion, and health-related quality of life: a multicenter, single-blinded, randomized, controlled pilot study. Park, M., Ko, MH., Oh, SW., et al.[2020]

In a study of 26 individuals in the acute stage of stroke, those who received intensive virtual reality (VR) training alongside conventional therapy showed significant improvements in upper extremity function as measured by the Fugl-Meyer Assessment (FMA) and Manual Function Test (MFT).

Both the VR and control groups improved in activities of daily living (ADL), but there were no significant differences between the two groups in overall upper extremity function or ADL performance, suggesting that while VR is beneficial, it may not provide additional advantages over conventional therapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of virtual reality on upper extremity function and activities of daily living performance in acute stroke: a double-blind randomized clinical trial. Kwon, JS., Park, MJ., Yoon, IJ., et al.[2016]

Virtual reality therapy significantly improves upper limb function and activities of daily living in stroke rehabilitation compared to conventional therapy, based on a review of 19 studies with 565 participants.

While virtual reality shows promise, it did not demonstrate significant effects on grip strength or gait speed, indicating that more research is needed to fully understand its benefits in stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochrane review: virtual reality for stroke rehabilitation. Laver, K., George, S., Thomas, S., et al.[2022]

A systematic review of 15 trials with 341 stroke patients found that replacing some or all standard rehabilitation with virtual reality-based rehabilitation (VRBR) significantly improved walking speed, balance, and mobility.

Adding VRBR to standard rehabilitation showed a small but significant improvement in mobility, although more research is needed to assess its impact on walking speed and balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation that incorporates virtual reality is more effective than standard rehabilitation for improving walking speed, balance and mobility after stroke: a systematic review. Corbetta, D., Imeri, F., Gatti, R.[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]

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 multi-faceted knowledge translation (KT) intervention improved therapists' knowledge and skills in using the Interactive Exercise Rehabilitation System (IREX) for stroke rehabilitation, with significant increases in perceived behavioral control and self-efficacy related to VR use.

Despite these improvements, the actual use of the IREX remained low due to perceived barriers such as poor system usability and lack of time, indicating that simply enhancing knowledge may not be enough to change practice behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A knowledge translation intervention to enhance clinical application of a virtual reality system in stroke rehabilitation. Levac, D., Glegg, SM., Sveistrup, H., et al.[2021]

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]

Virtual Reality-Based Rehabilitation (VRBR) significantly enhances patient engagement and motivation in stroke rehabilitation, leading to improved treatment adherence and functional recovery outcomes.

VRBR's ability to simulate real-life scenarios allows stroke survivors to practice essential daily activities, promoting greater functional independence compared to traditional rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the efficacy of virtual reality-based rehabilitation in stroke: a narrative review of current evidence. Aderinto, N., Olatunji, G., Abdulbasit, MO., et al.[2023]

Combining traditional rehabilitation with virtual reality significantly improves upper limb motor function and manual dexterity in stroke patients, as shown by a meta-analysis of 21 randomized controlled trials involving 619 participants.

However, this combined approach does not show a significant advantage over traditional rehabilitation in improving activities of daily living or balance, suggesting its primary benefit lies in enhancing specific motor skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Traditional Plus Virtual Reality Rehabilitation on Prognosis of Stroke Survivors: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Fang, Z., Wu, T., Lv, M., et al.[2022]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Current evidence on virtual reality and its potential usefulness in post-stroke neurorehabilitation]. [2020]

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

Effects of virtual reality-based planar motion exercises on upper extremity function, range of motion, and health-related quality of life: a multicenter, single-blinded, randomized, controlled pilot study. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of virtual reality on upper extremity function and activities of daily living performance in acute stroke: a double-blind randomized clinical trial. [2016]

4. Italy pubmed.ncbi.nlm.nih.gov

Cochrane review: virtual reality for stroke rehabilitation. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Rehabilitation that incorporates virtual reality is more effective than standard rehabilitation for improving walking speed, balance and mobility after stroke: a systematic review. [2022]

6. 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]

7. Canada pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality to Improve Outcomes in Veterans With Stroke: Protocol for a Single-Arm Pilot Study. [2021]

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

A knowledge translation intervention to enhance clinical application of a virtual reality system in stroke rehabilitation. [2021]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Exploring the efficacy of virtual reality-based rehabilitation in stroke: a narrative review of current evidence. [2023]

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

Effect of Traditional Plus Virtual Reality Rehabilitation on Prognosis of Stroke Survivors: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]