72 Participants Needed

Virtual Rehab Cycling for Parkinson's Disease

(PDBIKE Trial)

VS
AG
Overseen ByAasef G Shaikh, MD PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
Must be taking: Antiparkinsonian
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.678910

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.678910

Who Is on the Research Team?

AG

Aasef G. Shaikh, MD PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Are You a Good Fit for This Trial?

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.
See 1 more

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.
See 2 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Dynamic cycling
  • Forced cycling
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Dynamic cyclingExperimental Treatment1 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 cyclingActive Control1 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.

Dynamic cycling is already approved in United States for the following indications:

🇺🇸
Approved in United States as Dynamic cycling for:
  • Parkinson's disease rehabilitation

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Published Research Related to This Trial

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.
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.
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.
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]

Citations

Dynamic High-Cadence Cycling Improves Motor Symptoms in Parkinson's Disease. [2022]
Active-assisted cycling improves tremor and bradykinesia in Parkinson's disease. [2022]
Auditory and visual cueing modulate cycling speed of older adults and persons with Parkinson's disease in a Virtual Cycling (V-Cycle) system. [2018]
Acute effects of passive leg cycling on upper extremity tremor and bradykinesia in Parkinson's disease. [2011]
Improvement in upper-limb UPDRS motor scores following fast-paced arm exercise: A pilot study. [2023]
Musculoskeletal Effects of 2 Functional Electrical Stimulation Cycling Paradigms Conducted at Different Cadences for People With Spinal Cord Injury: A Pilot Study. [2018]
Clinical efficacy and prognostic indicators for lower limb pedalling exercise early after stroke: study protocol for a pilot randomised controlled trial. [2021]
Switched Control of Cadence During Stationary Cycling Induced by Functional Electrical Stimulation. [2017]
Corticospinal Excitability to the Biceps Brachii is Not Different When Arm Cycling at a Self-Selected or Fixed Cadence. [2020]
Cardiorespiratory demand of acute voluntary cycling with functional electrical stimulation in individuals with multiple sclerosis with severe mobility impairment. [2018]
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