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

Trial Summary

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 data supports the effectiveness of this treatment for Parkinson's disease?

Research shows that virtual reality (VR) rehabilitation can improve mobility, balance, and confidence in people with Parkinson's disease. VR-based exercises have been found to increase motivation and adherence to physical training, which is crucial for managing symptoms. Additionally, immersive VR video games have been well-received by patients, with high satisfaction and no adverse effects reported. ^{1 2 3 4 5}

Is exercise combined with virtual reality generally safe for humans?

Research shows that exercise combined with virtual reality is generally safe for humans. Studies involving healthy individuals and Parkinson's disease patients reported no adverse effects, with participants finding the activities enjoyable and safe. ^{2 6 7 8 9}

How is the Exercise + VR treatment for Parkinson's Disease different from other treatments?

This treatment is unique because it combines high-intensity exercise with virtual reality (VR) gaming, which can increase motivation and adherence to exercise. VR provides a safe and engaging environment that can improve mobility, balance, and cognitive function, making it a novel approach compared to traditional exercise programs. ^{2 10 11 12 13}

What is the purpose of this trial?

This study aims to determine the effects of aerobic exercise as a primer to add-on virtual reality (VR)-based rehabilitation on balance, postural control and neuroplasticity (ability of brain to adapt in structure and function) in individuals with Parkinson's disease (PD). This study will utilize two groups - one group will receive the exercise and VR, while the other group will receive stretching exercise and VR over eight weeks. The study team will administer outcomes at baseline, post-intervention (8 weeks) and follow-up (6 weeks after post-assessment).

Research Team

Anjali Sivaramakrishnan

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

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 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]

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]

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 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 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]

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 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 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]

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]

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]

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. 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]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Can Immersive Virtual Reality Videogames Help Parkinson's Disease Patients? A Case Study. [2021]

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

The role of exergaming in Parkinson's disease rehabilitation: a systematic review of the evidence. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Effect of virtual reality in Parkinson's disease: a prospective observational study. [2018]

6. United States 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. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Gamification of Cervical Spine Physiotherapy by Virtual Reality Software: Is This Real Rehabilitation? [2023]

9. China 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. [2022]

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

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

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

Perceptions of a Videogame-Based Dance Exercise Program Among Individuals with Parkinson's Disease. [2021]

12. Switzerland 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. [2023]

13. 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]