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

25 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Aerobic Exercise + Virtual Reality for Parkinson's Disease?

Research shows that virtual reality (VR) therapy can help improve balance, daily activities, and mood in Parkinson's disease patients. Studies also indicate that VR can safely promote physical activity and enhance rehabilitation outcomes, making it a promising addition to traditional exercise therapies for Parkinson's disease. ^{1 2 3 4 5}

Is aerobic exercise combined with virtual reality safe for people with Parkinson's disease?

Research shows that aerobic exercise combined with virtual reality is generally safe for people with Parkinson's disease, with studies reporting no adverse effects and high satisfaction among participants. ^{2 3 4 6 7}

How does the Aerobic Exercise + Virtual Reality treatment for Parkinson's Disease differ from other treatments?

This treatment combines aerobic exercise with virtual reality to enhance motivation and adherence, offering a unique way to improve mobility, balance, and quality of life for Parkinson's patients. Unlike traditional therapies, it allows for engaging, multisensory experiences that can be done at home, reducing travel burdens and increasing patient confidence. ^{2 3 4 7 8}

What is the purpose of this trial?

This project will provide preliminary data on the feasibility and effects of exercise and VR on motor behavior and neuroplasticity in PD. Results from this work will provide insight into whether combination interventions utilizing AE and VR have parallel effects on cognition, gait, and neuroplasticity in PD.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

References

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

Comparison of virtual reality rehabilitation and conventional rehabilitation in Parkinson's disease: a randomised controlled trial. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable Immersive Virtual Reality Device for Promoting Physical Activity in Parkinson's Disease Patients. [2022]

3. Japan 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. [2020]

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

Fully immersive virtual reality exergames with dual-task components for patients with Parkinson's disease: a feasibility study. [2023]

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

The effectiveness of virtual reality for rehabilitation of Parkinson disease: an overview of systematic reviews with meta-analyses. [2022]

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

Disparate effects of training on brain activation in Parkinson disease. [2019]

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

Tele-Rehabilitation with Virtual Reality: A Case Report on the Simultaneous, Remote Training of Two Patients with Parkinson Disease. [2023]

8. Italy pubmed.ncbi.nlm.nih.gov

The effects of augmented and virtual reality gait training on balance and gait in patients with Parkinson's disease. [2023]