Virtual Reality Games for Healthy Aging

Overseen By Édith Martin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TOPMED

Disqualifiers: Functional limitations, Cognitive impairments, Epilepsy, 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: 1

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this clinical trial is to understand the determinants and opportunities for acceptance of immersive technologies to support physical, cognitive, and social health and the possibilities for "aging well" among the new generation of older adults. The main questions it aims to answer are: * What are the needs and expectations in terms of immersive activities and intervention methods according to age? * Do different game modes influence the needs and expectations in immersive activities of this population? 50 participants will be asked to complete a preliminary questionnaire about their activity habits and preferences. They will then be invited to participate in individual or multiplayer virtual reality game trials, a post-trial discussion about their experience and a questionnaire completion.

Do I need to stop my current medications for this trial?

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 Games for Healthy Aging?

Research shows that virtual reality games can improve motivation and enjoyment in therapy, which may lead to better adherence and outcomes. Studies also suggest that VR games can enhance mobility skills and balance in older adults, potentially helping with fall prevention. ^{1 2 3 4 5}

Is it safe for humans to use virtual reality games for health purposes?

Research shows that immersive virtual reality games are generally safe for humans, with no serious adverse events reported in a study involving patients with brain injuries. Some users may experience mild side effects like dizziness, but these are not common. ^{6 7 8 9 10}

How is the virtual reality treatment for healthy aging different from other treatments?

The virtual reality treatment for healthy aging is unique because it uses interactive video games to encourage physical activity and improve balance in older adults, which is not a common approach in traditional therapies. This method is innovative as it combines entertainment with exercise, making it more engaging and potentially more effective for fall prevention and mobility improvement. ^{5 8 11 12 13}

Eligibility Criteria

This trial is for individuals who are 50 years or older and interested in how virtual reality can support healthy aging. It's not suitable for those with functional limitations, cognitive impairments, epilepsy risks, non-autonomy, or a pacemaker.

Inclusion Criteria

You are 50 years or older.

Exclusion Criteria

Having functional limitations

Having cognitive impairments

Being at risk of epilepsy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preliminary Assessment

Participants complete a preliminary questionnaire about their activity habits and preferences

1 week

1 visit (virtual)

Intervention

Participants engage in individual or multiplayer virtual reality game trials followed by a post-trial discussion and questionnaire completion

2 weeks

Multiple sessions (virtual)

Follow-up

Participants are monitored for changes in interest and perception of immersive activities

Immediately after intervention

Treatment Details

Interventions

• Virtual Reality Games

Trial Overview The study explores the impact of virtual reality games on physical, cognitive, and social health in older adults. Participants will answer questions about their habits and try out VR games to see if different modes affect their experience.

Participant Groups

Group I: Multiplayer then individual games Experimental Treatment 1 Intervention

Participants of this group will conduct the sessions in the following order : Focus group about multiplayer virtual reality games then Focus group about individual virtual reality games.

Group II: Individual then multiplayer games Experimental Treatment 1 Intervention

Participants of this group will conduct the sessions in the following order : Focus group about individual virtual reality games then Focus group about multiplayer virtual reality games.

Who Is Running the Clinical Trial?

TOPMED

Lead Sponsor

Trials

10

Recruited

290+

Fédération de l'Age D'Or du Québec

Collaborator

Trials

1

Recruited

50+

Fédération Québécoise des Loisirs en Institution

Collaborator

Trials

1

Recruited

50+

Conseil de recherches en sciences naturelles et en génie du Canada

Collaborator

Trials

3

Recruited

110+

SEC Fonds Immobilier Groupe Maurice

Collaborator

Trials

2

Recruited

100+

Findings from Research

Involving end users, such as therapists and rehabilitation clients, in the research and implementation of virtual reality (VR) and active video games (AVGs) can significantly improve the alignment of these technologies with their needs, potentially increasing clinical uptake.

The authors identified common benefits from user engagement, including enhanced buy-in from therapists and better technology integration, while also noting challenges in balancing technology capabilities with practical rehabilitation goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End-user involvement in rehabilitation virtual reality implementation research. Proffitt, R., Glegg, S., Levac, D., et al.[2022]

The mobile game-based VR rehabilitation program (MoU-Rehab) significantly improved upper extremity function in stroke patients compared to conventional therapy, as measured by the Fugl-Meyer Assessment and other metrics.

The program was well-tolerated with no adverse effects reported, and patients expressed high satisfaction, indicating its feasibility as a rehabilitation tool for upper limb recovery after ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. Choi, YH., Ku, J., Lim, H., et al.[2019]

The study involving 24 older women (average age 70.5 years) demonstrated that a combined pelvic floor muscle exercises and virtual reality rehabilitation (PFM/VRR) program is feasible, with high participation and adherence rates (91% and 92% respectively).

Post-treatment results showed significant improvements in urinary incontinence symptoms and quality of life, with 91% of participants reporting high satisfaction with the program, indicating its potential as an effective treatment option for mixed urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. Elliott, V., de Bruin, ED., Dumoulin, C.[2019]

Virtual reality (VR) rehabilitation systems can enhance human performance and health outcomes, with varying effects on postural stability, navigation tasks, and joint mobility depending on the level of immersion.

While the data on enjoyment and adherence to VR rehabilitation routines is limited, patients generally reported higher enjoyment and willingness to participate when VR was included in their care plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersion of virtual reality for rehabilitation - Review. Rose, T., Nam, CS., Chen, KB.[2018]

Virtual reality games have been shown to significantly improve balance and reduce fear of falling in elderly participants compared to no intervention, based on a review of 28 studies involving 1121 elderly individuals.

When compared to conventional therapy, virtual reality games were more effective in enhancing balance and mobility, although the overall evidence is inconclusive due to high risk of bias and variability in study protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do virtual reality games improve mobility skills and balance measurements in community-dwelling older adults? Systematic review and meta-analysis. Neri, SG., Cardoso, JR., Cruz, L., et al.[2019]

The study involving 78 patients with brain injury found that immersive virtual reality (VR) training is safe, with no serious adverse events reported, although some patients experienced minor issues like dizziness.

Patients who adhered to the VR training (participating 3 or more times) reported higher satisfaction and perceived effectiveness in their recovery from upper limb paralysis compared to those who participated less frequently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. Lim, I., Cha, B., Cho, DR., et al.[2023]

Stakeholders, including adolescents, parents, and community partners, expressed strong support for using the PlayForward videogame as an effective tool to teach important topics like sex, alcohol, and drugs, which are often neglected in educational settings.

The study identified that while stakeholders found the game acceptable, they also suggested the need for supplementary materials, such as manuals and discussion questions, to enhance its implementation in real-world environments like after-school programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

If We Build It, Will They Come? A Qualitative Study of Key Stakeholder Opinions on the Implementation of a Videogame Intervention for Risk Reduction in Adolescents. Pendergrass, TM., Hieftje, K., Crusto, CA., et al.[2023]

A 30-day virtual reality training program using Xbox 360 Kinect significantly improved balance and mobility in 23 elderly participants, as evidenced by enhanced scores in multiple functional tests, including the 6-minute walking test and Dynamic Gait Index.

The VR training not only improved physical performance but also reduced depressive symptoms, indicating that this innovative rehabilitation method can enhance both physical and mental well-being in fall-prone elderly individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality training in reducing the risk of falls among elderly people. Kamińska, MS., Miller, A., Rotter, I., et al.[2022]

In a study with 40 participants, both a motion-controlled video game and a sterile version led to similar improvements in learning, suggesting that engagement through game mechanics may not enhance learning outcomes as previously thought.

A significant relationship was found between self-reported engagement and the early-P3a component of brain activity, indicating that higher engagement levels are associated with more efficient information processing, as evidenced by reduced attentional reserve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship Between Engagement and Neurophysiological Measures of Attention in Motion-Controlled Video Games: A Randomized Controlled Trial. Leiker, AM., Miller, M., Brewer, L., et al.[2020]

Virtual reality (VR) technology can effectively assess fall risk in elderly individuals by capturing stepping performance parameters, providing a more immersive and intuitive experience compared to traditional clinical tests.

Using interactive game technology as a cost-effective alternative to expensive clinical equipment allows for reliable fall risk measurement, enabling seniors to focus on their motor and cognitive functions during the assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virtual Reality Game-Like Tool for Assessing the Risk of Falling in the Elderly. Garcia, JA.[2019]

A systematic review of 14 studies on the use of virtual reality and gaming systems by older adults found that while there is potential for these technologies to promote physical activity, the overall evidence for their effectiveness is weak due to low study quality and high risk of bias.

Feasibility of using VR/gaming systems was reported with good retention and adherence rates, but concerns about initial assistance, monitoring exertion, and risks of musculoskeletal symptoms and falls were noted, indicating the need for careful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and feasibility of virtual reality and gaming system use at home by older adults for enabling physical activity to improve health-related domains: a systematic review. Miller, KJ., Adair, BS., Pearce, AJ., et al.[2018]

Non-immersive virtual reality (VR) balance exercises significantly improve overall balance function in older adults, with a moderate to large effect size based on a meta-analysis of 25 studies.

The presence of avatars and knowledge of performance (KP) feedback during VR exercises enhances their effectiveness, particularly for static balance compared to gait improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of non-immersive virtual reality exercises for balance and gait improvement in older adults: A meta-analysis. Park, JH., Jeon, HS., Kim, JH., et al.[2023]

Videogame technology is increasingly being used in health care, particularly for rehabilitation in older adults after strokes or falls, highlighting its potential to improve independence.

The review emphasizes the need for a game classification system to ensure that videogames are suitable for the physical, cognitive, and social needs of older adults and those with disabilities, which could enhance their effectiveness in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Videogame Technologies to Support Independence in the Elderly: A Narrative Review. Marston, HR., Smith, ST.[2015]

References

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

End-user involvement in rehabilitation virtual reality implementation research. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. [2019]

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

Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. [2019]

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

Immersion of virtual reality for rehabilitation - Review. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Do virtual reality games improve mobility skills and balance measurements in community-dwelling older adults? Systematic review and meta-analysis. [2019]

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

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. [2023]

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

If We Build It, Will They Come? A Qualitative Study of Key Stakeholder Opinions on the Implementation of a Videogame Intervention for Risk Reduction in Adolescents. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality training in reducing the risk of falls among elderly people. [2022]

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

The Relationship Between Engagement and Neurophysiological Measures of Attention in Motion-Controlled Video Games: A Randomized Controlled Trial. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

A Virtual Reality Game-Like Tool for Assessing the Risk of Falling in the Elderly. [2019]

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

Effectiveness and feasibility of virtual reality and gaming system use at home by older adults for enabling physical activity to improve health-related domains: a systematic review. [2018]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of non-immersive virtual reality exercises for balance and gait improvement in older adults: A meta-analysis. [2023]

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

Interactive Videogame Technologies to Support Independence in the Elderly: A Narrative Review. [2015]