VR Therapy for Stroke Rehabilitation

Overseen By Virginia Chu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Sensory loss, Pain, Multiple strokes, others

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: Unknown

Duration: 12 days

13 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses VR technology to help stroke survivors practice arm movements in a simulated environment. The goal is to improve their arm strength and coordination, making it easier for them to perform everyday tasks. Virtual reality (VR) has shown promising results in improving motor function and daily activities.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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 data supports the idea that VR Therapy for Stroke Rehabilitation is an effective treatment?

The available research shows that VR Therapy for Stroke Rehabilitation is effective in improving arm function in stroke patients. One study found that patients who used immersive VR therapy showed greater improvements in arm movement and independence compared to those who received conventional therapy. Another review of multiple studies confirmed that VR therapy was more effective than traditional physical therapy in helping stroke patients regain arm function. These findings suggest that VR therapy can be a powerful tool for stroke rehabilitation. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment VR immersive therapy for stroke rehabilitation?

Research shows that immersive virtual reality (VR) therapy can significantly improve arm function in stroke patients compared to conventional therapy. This is because VR provides a realistic and engaging environment that helps patients practice movements and receive feedback, which can enhance brain recovery and improve physical abilities. ^{1 2 3 4 5}

What safety data exists for VR therapy in stroke rehabilitation?

The studies provided focus on the effectiveness and feasibility of VR therapy for stroke rehabilitation, but they do not explicitly mention safety data. However, the consistent use of VR therapy in various settings, such as home-based and fully immersive environments, suggests it is generally considered safe. The studies highlight improvements in upper limb function and electroencephalographic activity, indicating positive outcomes without reported adverse effects. Further research specifically addressing safety data would be beneficial. ^{1 6 7 8 9}

Is VR therapy safe for stroke rehabilitation?

Research on VR therapy for stroke rehabilitation suggests it is generally safe for use in humans, with studies showing it can improve arm function and brain activity without significant adverse effects. ^{1 6 7 8 9}

Is VR immersive therapy a promising treatment for stroke rehabilitation?

Yes, VR immersive therapy is a promising treatment for stroke rehabilitation. It helps improve motor skills, cognitive abilities, and psychological recovery. It also makes therapy more engaging and motivating for patients, which can lead to better results. ^{1 3 10 11 12}

How is VR Therapy for Stroke Rehabilitation different from other treatments?

VR Therapy for Stroke Rehabilitation is unique because it uses immersive virtual environments to engage multiple senses, enhancing motor and cognitive recovery by promoting neuroplasticity (the brain's ability to reorganize itself). This approach can make rehabilitation more motivating and enjoyable compared to traditional therapies. ^{1 3 10 11 12}

Research Team

Virginia Chu, PhD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for adults over 18 who had a stroke at least 6 months ago and have limited arm movement because of it. They must not be doing Yoga or Tai-Chi during the study, should have no severe cognitive issues, and can't have had multiple strokes or conditions like cyber-sickness that could affect participation.

Inclusion Criteria

My arms were fully functional before my stroke.

I finished my last treatment 2 months ago.

I will not attend Yoga, Tai-Chi, or similar classes during the study.

Exclusion Criteria

I experience significant pain in my arm that affects my daily activities.

I have had more than two strokes.

I cannot put on or take off a fitness tracker by myself and have no one to help me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive immersive Virtual Reality therapy combined with task-specific training

12 days

Follow-up

Participants are monitored for changes in hemiplegic arm movements after treatment

2-4 weeks

Treatment Details

Interventions

• VR immersive therapy

Trial Overview The study tests how well immersive Virtual Reality (VR) therapy combined with specific tasks helps improve arm function in people who've had a stroke. It looks to see if this high-tech approach encourages more arm movement than traditional methods.

Participant Groups

Group I: Virtual reality (VR) therapy Experimental Treatment 1 Intervention

VR immersive therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Immersive Virtual Reality Therapy for:

• Rehabilitation of hemiplegic arm function following stroke
• Improvement of upper limb function
• Enhancement of motor recovery

Approved in United States as VR Rehabilitation for:

• Post-stroke rehabilitation
• Upper extremity function improvement
• Motor function recovery

Approved in Canada as Virtual Reality-Based Arm Training for:

• Stroke rehabilitation
• Arm function recovery
• Neurological rehabilitation

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

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]

In a study of 65 ischemic stroke patients, immersive virtual reality (VR) rehabilitation significantly improved upper extremity function compared to conventional therapy, as measured by tests like the Fugl-Meyer Upper Extremity Scale and Action Research Arm Test.

While the VR group showed notable improvements in upper extremity function and self-care skills, it did not enhance overall functional independence, indicating that while VR is effective for specific rehabilitation goals, it may not address all aspects of recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Leap Motion-based 3D Immersive Virtual Reality Usage on Upper Extremity Function in Ischemic Stroke Patients. Ögün, MN., Kurul, R., Yaşar, MF., et al.[2020]

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]

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]

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]

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]

The study involved 12 chronic stroke patients who participated in either immersive virtual reality-based bilateral arm training (VRBAT) or normal bilateral arm training (NBAT) for 30 minutes, five times a week over four weeks, showing significant improvements in upper limb function for both groups.

Both VRBAT and NBAT were effective in enhancing upper limb function and electroencephalographic activity, although there was no significant difference in muscle activity between the two training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Immersive Virtual Reality-Based Bilateral Arm Training in Patients with Chronic Stroke. Song, YH., Lee, HM.[2021]

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]

A feasibility study involving 12 stroke patients demonstrated that a fully immersive virtual reality rehabilitation program using a head-mounted display (HTC Vive) is safe and effective for improving upper extremity function, with significant improvements observed in all functional outcome measures after 10 training sessions.

Participants reported high satisfaction with the VR training experience, averaging 6.3 out of 7 on a satisfaction scale, and no serious adverse effects were noted, indicating good usability of the VR system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper Extremity Rehabilitation Using Fully Immersive Virtual Reality Games With a Head Mount Display: A Feasibility Study. Lee, SH., Jung, HY., Yun, SJ., et al.[2021]

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]

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 involving 20 participants (10 with chronic stroke and 10 healthy adults), the EyeToy console was found to elicit significantly greater movement intensity compared to the Wii console for both groups, indicating its potential for enhancing rehabilitation exercises.

Both the EyeToy and Wii consoles were rated highly for usability and enjoyment, making them suitable options for stroke rehabilitation, but clinicians may prefer EyeToy for encouraging more intense movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sony PlayStation EyeToy elicits higher levels of movement than the Nintendo Wii: implications for stroke rehabilitation. Neil, A., Ens, S., Pelletier, R., et al.[2016]

References

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

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

2. Germany pubmed.ncbi.nlm.nih.gov

Effect of Leap Motion-based 3D Immersive Virtual Reality Usage on Upper Extremity Function in Ischemic Stroke Patients. [2020]

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

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

4. 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]

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

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

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

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

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

Effect of Immersive Virtual Reality-Based Bilateral Arm Training in Patients with Chronic Stroke. [2021]

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

Home-based virtual reality training after discharge from hospital-based stroke rehabilitation: a parallel randomized feasibility trial. [2020]

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

Upper Extremity Rehabilitation Using Fully Immersive Virtual Reality Games With a Head Mount Display: A Feasibility Study. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

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

11. 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]

12. Italy pubmed.ncbi.nlm.nih.gov

Sony PlayStation EyeToy elicits higher levels of movement than the Nintendo Wii: implications for stroke rehabilitation. [2016]