Exercise + VR for Parkinson's Disease

Overseen By Anjali Sivaramakrishnan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Seizure medications

Disqualifiers: Stroke, Multiple sclerosis, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 25

Duration: 8 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how aerobic exercise combined with virtual reality (VR) can help people with Parkinson's disease improve balance and brain function. Participants will be divided into two groups: one performing high-intensity exercises with VR gaming, and the other doing stretching exercises with VR. It suits those diagnosed with Parkinson's who find balance or mobility challenging and are interested in new ways to manage symptoms. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to managing Parkinson's symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes individuals using medications that could affect brain activity or increase seizure risk. It's best to discuss your specific medications with the trial team.

What prior data suggests that this exercise and VR-based rehabilitation is safe for individuals with Parkinson's disease?

Past studies found no reported side effects from using virtual reality (VR) for Parkinson's disease. Participants were just as likely to continue with VR exercises as with other exercise types. Research has also shown that combining exercise with VR is generally safe. High-intensity exercise, such as indoor cycling, is considered a good and safe option for people with Parkinson's disease. These findings suggest that both the high-intensity exercise and VR games used in this study are safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining exercise with virtual reality (VR) gaming for Parkinson's disease because it offers a unique and engaging way to potentially improve motor functions. Unlike standard treatments, which often rely on medication like levodopa to manage symptoms, this approach incorporates high-intensity endurance exercises and interactive VR games. This method not only targets physical fitness but also stimulates cognitive and sensory engagement, which could enhance overall brain health. Additionally, the use of VR makes the exercise routine more enjoyable and motivating, which might lead to better adherence and more significant improvements in patients' daily lives.

What evidence suggests that this trial's treatments could be effective for Parkinson's disease?

This trial will compare two exercise regimens combined with virtual reality (VR) for people with Parkinson's disease. One group will participate in high-intensity endurance exercise with VR-based gaming, while the other group will engage in stretching exercises with VR-based gaming. Studies have shown that combining high-intensity exercise with VR can improve balance and movement in Parkinson's patients. These programs create realistic environments where participants perform activities that enhance physical abilities. Research indicates that VR-based rehabilitation can lead to better daily functioning, improved quality of life, and may even slow disease progression. High-intensity exercise with VR has effectively improved motor skills and the body's ability to use oxygen efficiently. This approach might also enhance neuroplasticity, the brain's ability to adapt and change. ^{1 2 6 7 8}

Who Is on the Research Team?

Anjali Sivaramakrishnan

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for people aged 18-85 with Parkinson's Disease in moderate stages (2-3), who can think clearly (score ≥23 on a mental exam) and have some balance issues (score ≤21.5 on a balance test). It's not for those with other neurological conditions, severe heart/lung/bone/joint diseases, uncontrolled diabetes or hypertension, brain surgery for PD, head injuries, seizures/epilepsy, pregnancy, certain medications or skull problems.

Inclusion Criteria

My balance score is 21.5 or lower.

You need to score 23 or higher on a test that checks how well your brain is working.

I have Parkinson's disease, am between 18-85 years old, and my condition is moderate.

Exclusion Criteria

Subjects with a history of head injury

I take medication that could affect my brain's activity or increase my risk of seizures.

I have a history of neurological diseases like stroke or multiple sclerosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either high intensity endurance exercise and VR or stretching and VR, performed 3 times a week for 8 weeks

8 weeks

24 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High intensity endurance exercise
• Stretching exercise
• Virtual reality (VR)-based gaming

Trial Overview

The study tests if high-intensity endurance exercise followed by VR-based gaming improves balance and brain adaptability in Parkinson's patients compared to just stretching exercises plus VR. Participants are split into two groups randomly and assessed over eight weeks of treatment and six weeks after.

How Is the Trial Designed?

Group I: Stretching and virtual reality (control) Experimental Treatment 2 Interventions

The stretching group will perform stretching exercises and VR-based games 3 times a week for 8 weeks.

Group II: High intensity endurance exercise and virtual reality (experimental) Experimental Treatment 2 Interventions

The exercise group will perform high intensity interval exercise and VR-based games 3 times a week for 8 weeks.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

A 6-week virtual reality rehabilitation program significantly improved balance and gait in patients with Parkinson's disease compared to a conventional rehabilitation program, as shown by higher scores on the Balance Berg Scale and Dynamic Gait Index.

The VR program also enhanced mental quality of life, while the conventional program only showed improvement in upper limb performance, indicating that VR may offer a more comprehensive benefit for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of virtual reality rehabilitation and conventional rehabilitation in Parkinson's disease: a randomised controlled trial. Pazzaglia, C., Imbimbo, I., Tranchita, E., et al.[2021]

Exergaming, particularly using platforms like Nintendo Wii, shows promise as a rehabilitation tool for improving motor symptoms in people with Parkinson's disease, with six studies indicating positive effects on balance and motor function.

The only randomized controlled trial found that exergaming was as effective as traditional balance training, with benefits maintained for 60 days post-training, but more research is needed to assess safety and tailor games to the specific needs of individuals with Parkinson's.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of exergaming in Parkinson's disease rehabilitation: a systematic review of the evidence. Barry, G., Galna, B., Rochester, L.[2022]

A novel telerehabilitation program using a treadmill-virtual reality system for patients with Parkinson's disease showed high adherence to training and significant improvements in walking duration, gait speed, and overall mobility over a year-long period.

The program allowed simultaneous training of two patients at home, which not only enhanced individual treatment but also saved time for therapists, making it a practical solution for maintaining exercise adherence during challenges like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-Rehabilitation with Virtual Reality: A Case Report on the Simultaneous, Remote Training of Two Patients with Parkinson Disease. Cornejo Thumm, P., Giladi, N., Hausdorff, JM., et al.[2023]

A 6-week treadmill training combined with virtual reality (TT + VR) led to decreased brain activation in certain areas associated with cognitive control in patients with Parkinson's disease, suggesting improved brain efficiency during ambulation tasks.

The study found that the TT + VR group showed a correlation between reduced fall frequency and changes in brain activation, indicating that this combined training may enhance both motor function and cognitive processing in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disparate effects of training on brain activation in Parkinson disease. Maidan, I., Rosenberg-Katz, K., Jacob, Y., et al.[2019]

A dance exercise program using the video game 'Dance Dance Revolution' (DDR) was found to be enjoyable and easy to use for 16 participants with mild to moderate Parkinson's disease, potentially improving their adherence to physical activity.

Participants reported benefits such as improved balance and coordination, indicating that DDR could effectively incorporate key physical therapy recommendations for Parkinson's disease, warranting further research in a larger study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of a Videogame-Based Dance Exercise Program Among Individuals with Parkinson's Disease. Natbony, LR., Zimmer, A., Ivanco, LS., et al.[2021]

The study demonstrated that fully immersive virtual reality (VR) exergames, which combine physical and cognitive tasks, can improve balance and executive function in patients with Parkinson's disease, with significant improvements noted in the Berg Balance Scale and Stroop test.

The intervention was well-tolerated by the 12 participants, with no serious adverse effects reported, indicating that VR exergames can be a safe and engaging rehabilitation tool for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fully immersive virtual reality exergames with dual-task components for patients with Parkinson's disease: a feasibility study. Yun, SJ., Hyun, SE., Oh, BM., et al.[2023]

Immersive virtual reality video gaming is a feasible rehabilitation tool for patients with mild to moderate Parkinson's disease, as demonstrated by a study involving four participants aged 53-71 years.

All participants reported high satisfaction and usability scores after two gaming sessions, with no adverse effects or symptoms of simulator sickness, indicating a safe and effective approach for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Immersive Virtual Reality Videogames Help Parkinson's Disease Patients? A Case Study. Campo-Prieto, P., Rodríguez-Fuentes, G., Cancela-Carral, JM.[2021]

A study involving 16 patients with Parkinson's disease demonstrated that balance exercises using virtual reality games significantly improved balance and reduced dizziness, as measured by the Dizziness Handicap Inventory and Berg Balance Scale.

The Tightrope Walk and Ski Slalom virtual reality games were particularly effective, leading to notable improvements in functional capacity and mental health aspects of the participants after rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of virtual reality in Parkinson's disease: a prospective observational study. Severiano, MIR., Zeigelboim, BS., Teive, HAG., et al.[2018]

A network meta-analysis of 60 randomized controlled trials involving 2859 Parkinson's disease patients found that dance training significantly improves balance and reduces motor symptoms, as indicated by the Berg Balance Scale and Unified Parkinson's Disease Rating Scale scores.

Yoga, along with dance, virtual reality training, and resistance training, also showed notable benefits for motor function in Parkinson's patients, suggesting these interventions are particularly effective compared to other exercise options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Ten Different Exercise Interventions on Motor Function in Parkinson's Disease Patients-A Network Meta-Analysis of Randomized Controlled Trials. Hao, Z., Zhang, X., Chen, P.[2023]

A 30-minute immersive virtual reality (IVR) exergaming session resulted in a high energy expenditure of 440 calories and a mean heart rate of 176 beats per minute, indicating significant metabolic and physiological demand among 14 healthy college-aged participants.

Participants found the IVR training enjoyable, rating it as 'somewhat hard-to-hard' on the exertion scale, and reported no symptoms of cybersickness, suggesting that IVR exergaming could be a safe and effective way to enhance fitness and health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological and Metabolic Requirements, and User-Perceived Exertion of Immersive Virtual Reality Exergaming Incorporating an Adaptive Cable Resistance System: An Exploratory Study. Hu, J., Browne, JD., Arnold, MT., et al.[2021]

In a study involving 20 healthy participants, a fully immersive virtual reality game (VRPhysio) successfully prompted neck movements that were identified by physiotherapists as appropriate rehabilitation exercises.

No adverse events were reported during the session, suggesting that VR gamification could be a safe and effective method for encouraging adherence to neck rehabilitation exercises, warranting further evaluation in randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamification of Cervical Spine Physiotherapy by Virtual Reality Software: Is This Real Rehabilitation? Gavish, L., Weissberger, O., Barzilay, Y.[2023]

Active video games in fully immersive virtual reality (AVR) significantly increased moderate-to-vigorous physical activity (MVPA) compared to sedentary virtual reality (SVR) and control sessions, as measured by heart rate and accelerometers in a study of 29 college students.

Participants reported a more engaging and enjoyable experience during AVR sessions, which also led to marginally better cognitive performance on a memory test, indicating that AVR can enhance both physical activity and cognitive function without increasing motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active video games in fully immersive virtual reality elicit moderate-to-vigorous physical activity and improve cognitive performance in sedentary college students. Sousa, CV., Hwang, J., Cabrera-Perez, R., et al.[2022]

A study involving 32 patients with mild to moderate Parkinson's disease demonstrated that a boxing exergame using a wearable head-mounted display (HMD) was safe and well-received, with no adverse effects reported during 60 sessions.

Participants reported high satisfaction (88% rated the training as 'good' or 'very good') and good usability of the HMD (average score of 75.16/100), indicating that VR exergaming could be an effective way to promote physical activity in people with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Immersive Virtual Reality Device for Promoting Physical Activity in Parkinson's Disease Patients. Campo-Prieto, P., Cancela-Carral, JM., Rodríguez-Fuentes, G.[2022]

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