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

Trial Summary

What is the purpose of this trial?

While stroke survivors discharged from rehabilitation present with some recovery in mobility, their ability to ambulate in the community remains limited. The investigators propose to test a novel, low-cost, intensive and individually tailored intervention that combines virtual reality (VR) and field training to enhance community ambulation and participation in stroke survivors discharged from rehabilitation. The aims are to: (1) Assess feasibility, acceptability, safety and adherence of the intervention in stroke survivors; and (2) Examine the extent to which post-intervention changes in functional walking and participation to community walking vary according to walking, cognitive and visual-perceptual abilities. The investigators will use a virtual environment prototype simulating a shopping mall and surrounding streets, in which participants will interact using VR goggles and game controllers. Scenarios of increasing levels of complexity will be introduced. This intervention study involves a single group, multiple pre- multiple post- study design where chronic stroke participants will engage in a 4-week training program. The program will include VR training sessions performed in the clinical setting (3/week) and practice of community ambulation skills while supervised by family/caregivers (2/week). Participants will be assessed on measures of functional walking, balance \& mobility and participation to community walking. Adherence, safety and acceptability will be documented. This study will generate foundation knowledge on the response to the intervention based on individual capacities.

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 effectiveness of the treatment Virtual Reality Therapy for Stroke Recovery?

Research shows that virtual reality training can help improve arm function, balance, and walking in stroke patients. It is a promising tool for stroke rehabilitation, providing feedback that can enhance recovery. ^{1 2 3 4 5}

Is virtual reality therapy safe for stroke recovery?

The research does not specifically mention safety concerns, suggesting that virtual reality therapy is generally considered safe for stroke recovery. ^{1 2 6 7 8}

How is Virtual Reality Therapy for Stroke Recovery different from other treatments?

Virtual Reality Therapy for stroke recovery is unique because it uses computer simulations to create interactive environments that help improve motor skills, balance, and cognitive functions. This therapy can be done at home, making it more accessible and convenient for patients who may have difficulty accessing traditional rehabilitation services. ^{1 2 3 5 9}

Research Team

Anouk Lamontagne, PhD

Principal Investigator

McGill University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Canada 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. [2021]

3. Spain pubmed.ncbi.nlm.nih.gov

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

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

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

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

Effect of Virtual Reality Training on Balance and Gait Ability in Patients With Stroke: Systematic Review and Meta-Analysis. [2022]

6. England 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. [2022]

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

Sitting Balance Exercise Performed Using Virtual Reality Training on a Stroke Rehabilitation Inpatient Service: A Randomized Controlled Study. [2021]

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

Virtual reality therapy for upper limb rehabilitation in patients with stroke: a meta-analysis of randomized clinical trials. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

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