Aerobic Exercise + Virtual Reality for Parkinson's Disease

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, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining aerobic exercise (a type of physical activity that improves cardiovascular fitness) with virtual reality can help people with Parkinson's Disease move better and think more clearly. Researchers aim to determine if this combination can improve walking, thinking skills, and brain health. The trial seeks participants diagnosed with Parkinson's Disease who experience movement difficulties. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance the quality of life for those with Parkinson's Disease.

Will I have to stop taking my current medications?

The trial excludes participants who use medications that could alter brain activity or increase the risk of seizures, so you may need to stop certain medications. It's best to discuss your specific medications with the trial team.

What prior data suggests that this combination of aerobic exercise and virtual reality is safe for individuals with Parkinson's Disease?

Research has shown that virtual reality (VR) in rehabilitation for Parkinson's disease (PD) can improve walking ability similarly to traditional physical therapy, suggesting it could be a useful tool without additional risks. One study found that immersive VR is safe for managing PD and might even enhance the benefits of physical therapy.

Intense aerobic activities, such as indoor cycling, are considered safe and may help protect the brain and nerves in people with PD.

Overall, combining aerobic exercise and VR appears well-tolerated by people with Parkinson's. No strong evidence of serious side effects exists, making it a promising approach to explore in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of aerobic exercise and virtual reality for Parkinson's Disease because this approach offers a fresh angle compared to standard treatments like medication and physical therapy. Unlike traditional methods, this treatment uses virtual reality to create engaging and immersive environments that can enhance motivation and potentially improve motor skills more effectively. Moreover, incorporating aerobic exercise can boost cardiovascular health and brain function, which might lead to better overall outcomes for those with Parkinson's Disease. This innovative blend of physical activity and technology aims to address both the physical and cognitive challenges of the condition in a novel way.

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

Research shows that combining aerobic exercise with virtual reality (VR) can benefit people with Parkinson's disease. In this trial, participants will engage in a combined aerobic exercise and VR-based program. Studies have found that VR can moderately improve the distance and quality of walking in people with Parkinson's. Aerobic exercise is known to protect and enhance brain functions, which is crucial for Parkinson's patients. Specifically, one study found that a 6-week VR rehab program significantly improved balance and walking ability compared to regular therapy. This suggests that using both aerobic exercise and VR might enhance movement and brain health in people with Parkinson's. ^{1 3 5 6 7}

Who Is on the Research Team?

Anjali Sivaramakrishnan, PT, PhD

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 early to mid-stages (stages 1-3) who can think clearly enough (score ≥23 on a mental state exam). It's not for those with other neurological diseases, severe heart/lung conditions, uncontrolled diabetes or blood pressure issues, severe bone weakness, brain surgery for PD, head injuries, seizures/epilepsy, pregnancy or certain medication use.

Inclusion Criteria

Subjects need to demonstrate a score of equal to or greater than 23 on the Mini Mental State Examination

Exclusion Criteria

I have skull abnormalities, fractures, or often get unexplained headaches.

Subjects who are currently pregnant

Subjects with a history of seizures or epilepsy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform aerobic exercise followed by virtual reality to assess effects on motor behavior and neuroplasticity

3 weeks

Multiple sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise
• Virtual Reality

Trial Overview

The study tests how aerobic exercise combined with virtual reality affects movement and brain changes in Parkinson's. Participants will do physical exercises while engaging in VR tasks to see if this improves their motor skills and cognitive functions.

How Is the Trial Designed?

Group I: Combined Aerobic Exercise (AE) and Virtual Reality (VR)-based program Experimental Treatment 2 Interventions

Individuals diagnosed with PD will participate in AE and VR.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Texas Physical Therapy Association

Collaborator

Trials

6

Recruited

190+

Published Research Related to This Trial

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]

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]

In a study involving 20 Parkinson's disease patients, those who participated in virtual reality dance exercise showed significant improvements in balance, daily living activities, and depressive symptoms after 6 weeks of treatment.

The experimental group, which included dance exercise in addition to standard neurodevelopment treatment and electrical stimulation, outperformed the control group in all assessed areas, highlighting the potential of dance as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of virtual reality dance exercise on the balance, activities of daily living, and depressive disorder status of Parkinson's disease patients. Lee, NY., Lee, DK., Song, HS.[2020]

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]

Virtual reality (VR) therapy shows potential benefits for improving stride/step length, balance, and neuropsychiatric symptoms in patients with Parkinson's disease, but the overall quality of evidence is low to very low due to poor methodological quality in the systematic reviews analyzed.

The review highlighted that while VR therapy may outperform passive interventions in several areas like gait speed and activities of daily living, the lack of high-quality randomized controlled trials means we cannot confidently determine its overall effectiveness or safety for patients with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality for rehabilitation of Parkinson disease: an overview of systematic reviews with meta-analyses. Lu, Y., Ge, Y., Chen, W., et al.[2022]

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]

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]

Augmented reality (AR) and virtual reality (VR) gait training significantly improved motor symptoms, balance, and gait in 30 patients with Parkinson's Disease over 6 weeks, compared to conventional training alone.

While both training methods improved balance confidence and some gait parameters, the AR and VR group showed greater overall improvements in various motor and functional mobility assessments, highlighting the efficacy of immersive training environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of augmented and virtual reality gait training on balance and gait in patients with Parkinson's disease. Gulcan, K., Guclu-Gunduz, A., Yasar, E., et al.[2023]

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Aerobic Exercise + Virtual Reality for Parkinson's Disease

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