Virtual Rehab Cycling for Parkinson's Disease

(PDBIKE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Aasef G. Shaikh, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Must be taking: Antiparkinsonian

Disqualifiers: Stroke, Atypical parkinsonism, Cardiovascular, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This research will develop novel and accessible way to deliver effective and customized rehab to those suffering from common and devastating neurodegenerative condition called Parkinson's disease. The investigators will examine the efficacy of novel rehab technique that can be monitored and modified in real-time but over virtual interface using a remotely located device in a paradigm called dynamic cycling. This technology will benefit thousands of Veterans who need customized and cost-effective rehab but cannot travel to specialized facilities due to inevitable limitations such as pandemics or because of lack of resources, social support, frailty, or home-bound status.

Will I have to stop taking my current medications?

The trial requires that participants have a stable medical regimen of antiparkinsonian medication for at least six months, so you will not need to stop taking your current medications if they are stable.

What data supports the effectiveness of the treatment Virtual Rehab Cycling for Parkinson's Disease?

Research shows that high-cadence cycling, including forced and active-assisted cycling, can improve motor symptoms like tremor and bradykinesia (slowness of movement) in people with Parkinson's disease. Additionally, virtual environments with auditory and visual cues can enhance exercise intensity and engagement, potentially benefiting motor function. ^{1 2 3 4 5}

Is virtual rehab cycling safe for humans?

Research on functional electrical stimulation (FES) cycling, which is similar to virtual rehab cycling, shows it is generally safe for humans. Studies involving people with conditions like multiple sclerosis and spinal cord injury have not reported significant safety concerns, suggesting it is a safe exercise option. ^{6 7 8 9 10}

How is the Virtual Rehab Cycling treatment for Parkinson's disease different from other treatments?

Virtual Rehab Cycling is unique because it uses high-cadence cycling, which involves pedaling at a fast pace, to improve motor symptoms in Parkinson's disease. This approach is different from traditional treatments as it combines physical exercise with virtual environments and cueing strategies to enhance engagement and effectiveness. ^{1 2 3 4 5}

Research Team

Aasef G. Shaikh, MD PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Eligibility Criteria

This trial is for individuals with Parkinson's Disease who can consent, have been on stable Parkinson's medication for at least six months, and are in stages I-III of the disease without medication. It excludes those with severe cognitive impairment, depression or anxiety disorders, certain other neurological conditions, untreated cardiovascular issues, or significant fatigue or breathlessness during mild activity.

Inclusion Criteria

My Parkinson's is in the early to mid stages without medication.

My Parkinson's medication has been the same for at least 6 months.

You have been diagnosed with Parkinson's disease using the UK Brain Bank criteria.

Exclusion Criteria

I have symptoms like chest pain or shortness of breath, indicating heart issues.

I have been diagnosed with a brain injury, stroke, or a type of Parkinson's disease.

Your anxiety score is higher than 24 on the Hamilton scale.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in dynamic cycling exercise regimen, monitored and adjusted remotely, for 4 weeks

4 weeks

Remote monitoring with wearable sensors

Follow-up

Participants are monitored for changes in motor function, balance, and cognitive outcomes at 0, 3, and 6 months after the intervention

6 months

Remote assessments at 0, 3, and 6 months

Treatment Details

Interventions

• Dynamic cycling (Behavioural Intervention)
• Forced cycling (Behavioural Intervention)

Trial Overview The study tests a new rehab method called dynamic cycling that patients can do from home using virtual technology. This could help people who can't travel to specialized centers due to various limitations like pandemics or lack of resources.

Participant Groups

Group I: Dynamic cycling Experimental Treatment 1 Intervention

The cycling parameters will change according to motor performance of the participants. Motor performance will be measured by assessing the change in tremor and movement speed.

Group II: Forced cycling Active Control 1 Intervention

The cycling parameters will not change regardless of the motor performance. Motor performance will be measured by assessing the change in tremor and movement speed.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Louis Stokes VA Medical Center, Cleveland, OH Cleveland, OH

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1691

Patients Recruited

3,759,000+

Findings from Research

Dynamic cycling at a high cadence (75-85 rpm) significantly improved motor function in individuals with Parkinson's disease, showing a 13.9% improvement in UPDRS scores and a 16.5% improvement in Timed Up and Go (TUG) times after just three sessions.

In contrast, static cycling resulted in only minor improvements (0.9% in UPDRS scores and 8% in TUG times), suggesting that the high cadence and dynamic nature of cycling are crucial for enhancing motor function in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic High-Cadence Cycling Improves Motor Symptoms in Parkinson's Disease. Ridgel, AL., Phillips, RS., Walter, BL., et al.[2022]

A pilot trial involving 10 individuals with Parkinson's disease demonstrated that a 40-minute session of active-assisted cycling (AAC) was well tolerated and did not cause excessive fatigue.

Most participants experienced immediate improvements in tremor and bradykinesia after the AAC session, suggesting that high-intensity cycling could be an effective intervention for enhancing motor function in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active-assisted cycling improves tremor and bradykinesia in Parkinson's disease. Ridgel, AL., Peacock, CA., Fickes, EJ., et al.[2022]

Persons with Parkinson's disease (PD) and age-matched healthy adults both increased their pedaling rates while cycling in a virtual environment (VE) with auditory and visual cues, indicating that these cues can effectively enhance exercise intensity.

However, individuals with PD needed explicit instructions to focus on visual cues to increase their cycling speed, suggesting that attention to cues is crucial for this group to benefit from the exercise intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory and visual cueing modulate cycling speed of older adults and persons with Parkinson's disease in a Virtual Cycling (V-Cycle) system. Gallagher, R., Damodaran, H., Werner, WG., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of passive leg cycling on upper extremity tremor and bradykinesia in Parkinson's disease. Ridgel, AL., Muller, MD., Kim, CH., et al.[2011]

A pilot study involving 10 participants with Parkinson's disease showed that a 50-minute session of fast-paced rhythmic upper limb exercise improved their movement accuracy and speed, indicating potential benefits for motor function.

The exercise program also led to significant improvements in upper-limb motor scores, suggesting that rhythmic movements could be a feasible and beneficial intervention for patients with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in upper-limb UPDRS motor scores following fast-paced arm exercise: A pilot study. Levy-Tzedek, S., Arbelle, D., Forman, D., et al.[2023]

Low cadence cycling (20 RPM) resulted in greater torque and improved bone health indicators, such as decreased bone turnover markers, compared to high cadence cycling (50 RPM) in individuals with spinal cord injury, suggesting it may be more beneficial for musculoskeletal health.

Both cycling methods increased muscle volume, but low cadence cycling showed potential for better trabecular bone microarchitecture, indicating it could help reduce fracture risk in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Musculoskeletal Effects of 2 Functional Electrical Stimulation Cycling Paradigms Conducted at Different Cadences for People With Spinal Cord Injury: A Pilot Study. Johnston, TE., Marino, RJ., Oleson, CV., et al.[2018]

This study will assess whether pedalling on a modified exercise bike can enhance recovery in stroke survivors who are within 30 days post-stroke and have unilateral weakness, involving 24 participants in a randomized controlled trial.

The primary outcome will measure the ability to voluntarily contract affected lower limb muscles, which could provide insights into the effectiveness of early pedalling exercise as a rehabilitation strategy after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy and prognostic indicators for lower limb pedalling exercise early after stroke: study protocol for a pilot randomised controlled trial. Hancock, NJ., Shepstone, L., Rowe, P., et al.[2021]

A new stimulation pattern for functional electrical stimulation (FES) cycling was developed, which improved muscle control and efficiency in producing forward torque, leading to better cadence tracking in both able-bodied individuals and a subject with Parkinson's disease.

Experimental results showed that the new controller achieved low cadence tracking errors of 5.27 ± 2.14 revolutions per minute during FES-induced cycling in able-bodied subjects and even lower errors in a Parkinson's disease subject, indicating its potential effectiveness for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Switched Control of Cadence During Stationary Cycling Induced by Functional Electrical Stimulation. Bellman, MJ., Cheng, TH., Downey, RJ., et al.[2017]

The study found that corticospinal excitability to the biceps brachii muscle remains unchanged whether participants cycle at a self-selected cadence or a fixed cadence, indicating that the cycling speed does not affect motor cortex activity.

Using transcranial magnetic stimulation (TMS) to measure motor evoked potentials (MEPs) in both conditions showed no significant differences, suggesting that the brain's control over muscle activation is consistent regardless of cycling pace.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticospinal Excitability to the Biceps Brachii is Not Different When Arm Cycling at a Self-Selected or Fixed Cadence. Lockyer, EJ., Nippard, AP., Kean, K., et al.[2020]

In a study involving 11 participants with severe mobility impairment due to multiple sclerosis, functional electrical stimulation (FES) cycling was found to significantly improve cardiorespiratory fitness (CRF) compared to passive leg cycling, indicating its potential as an effective exercise modality.

The FES cycling resulted in moderate-to-vigorous intensity exercise, with participants achieving 63.5% of their peak oxygen consumption and 76.4% of their peak heart rate, suggesting that it can provide a sufficient stimulus for enhancing CRF in individuals with severe MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorespiratory demand of acute voluntary cycling with functional electrical stimulation in individuals with multiple sclerosis with severe mobility impairment. Edwards, T., Motl, RW., Pilutti, LA.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Dynamic High-Cadence Cycling Improves Motor Symptoms in Parkinson's Disease. [2022]

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

Active-assisted cycling improves tremor and bradykinesia in Parkinson's disease. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Auditory and visual cueing modulate cycling speed of older adults and persons with Parkinson's disease in a Virtual Cycling (V-Cycle) system. [2018]

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

Acute effects of passive leg cycling on upper extremity tremor and bradykinesia in Parkinson's disease. [2011]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Improvement in upper-limb UPDRS motor scores following fast-paced arm exercise: A pilot study. [2023]

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

Musculoskeletal Effects of 2 Functional Electrical Stimulation Cycling Paradigms Conducted at Different Cadences for People With Spinal Cord Injury: A Pilot Study. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Clinical efficacy and prognostic indicators for lower limb pedalling exercise early after stroke: study protocol for a pilot randomised controlled trial. [2021]

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

Switched Control of Cadence During Stationary Cycling Induced by Functional Electrical Stimulation. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Corticospinal Excitability to the Biceps Brachii is Not Different When Arm Cycling at a Self-Selected or Fixed Cadence. [2020]

10. Canada pubmed.ncbi.nlm.nih.gov

Cardiorespiratory demand of acute voluntary cycling with functional electrical stimulation in individuals with multiple sclerosis with severe mobility impairment. [2018]