Remote Dynamic Cycling for the Customized Off-site Rehab in Parkinson's Disease (PDBIKE)

VA Office of Research and Development

Status: Enrolling

Conditions: Parkinson's Disease

Treatments: Other: Dynamic cycling; Other: Forced cycling

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05298150

E3676-R

1I01RX003676-01A2 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Parkinson's disease (PD) progressively deteriorates motor function. Successful rehabilitation, leading to a favorable course of movement disorders in PD, is contingent upon frequent, regular, and patient-specific exercise regimen that is customized to the individual needs. Latter requires regular interventions from the provider and frequent visits to the rehab facility. Lack of access, poor social support, inability to travel, home-bound status, or pandemics are significant hurdles in delivering effective rehab to the PD patients. The investigators' vision is to offer customized and cost-effective PD rehab using a remotely operated technology near or at the patients' homes. This technology would be remotely monitored and customized online to titrate therapeutic outcomes optimized for each patient. The proof of this concept was already established in the investigators' laboratory, a technology called dynamic cycling. The highlight of this technology is a stationary bike operating at a rapid speed (cadence) with programmable variability in speed and power/torque hence promoting motor performance superior to traditional motorized bikes (i.e. static cycling). The next step towards the ultimate vision of at-home exercise therapy is remotely operated dynamic bike. The investigators have already built remotely operated dynamic bike; the current proposal will objectively examine the efficacy of a novel, remotely delivered and remotely adjusted dynamic cycling paradigm using remotely monitored motor outcomes. Comparison will be made with remote static cycling. The study will be launched at three community based wellness locations to assure the subject safety, ease of access, compliance, and as needed support. Aim 1 will examine the hypothesis that dynamic cycling will immediately improve the motor function in PD. The effects will be prominent on the dopamine-sensitive motor deficits. The repetition will enhance motor improvement. The participants will use wearable sensors for the remote assessments of motor symptoms in PD before and immediately after each exercise session. The information from the wearable sensors and the bike will be utilized to further adjust the bike parameters for the next dynamic cycling session. The investigators will also measure effects on subjective ratings of motor function, cognition and balance before, and at 0, 3, and 6 months after the cycling intervention. Aim 2 will analyze the effects of dynamic cycling on motor fluctuations, declining response to levodopa in an early and unpredictable manner significantly affecting the quality of life in the PD. The investigators hypothesize that dynamic cycling will reduce the motor fluctuations in PD. The efficacy of dynamic cycling on improvement in motor fluctuation over a 12-hour awake period will be measured every day with the wearable sensors that communicate via secure cloud. The immediate clinical impact is that the technology will be immediately deployed to the Veteran's group homes, nursing homes, and community based VA clinics. The project will provide sufficient information to carry the investigators' ultimate vision, at-home dynamic cycling serving three critical needs: 1) customized therapy, 2) easy access, and 3) safety and cost-effectiveness.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Diagnosis of PD using the UK Brain Bank criteria

• Ability to perform informed consent.
• Hoehn and Yahr (H&Y) stages I-III when off medication,
• Stable medical regimen of antiparkinsonian medication for at least six months

Exclusion criteria

• Montreal Cognitive Assessment Scoreless than 18
• Hamilton depression score of 20 or higher
• Hamilton anxiety rating score greater than 24
• Clinical diagnosis including perinatal brain injury, stroke, and atypical parkinsonism
• One or more signs or symptoms of untreated cardiovascular disease including Pain, discomfort in the chest, neck, jaw, arms or other areas that may result from ischemia - Shortness of breath at rest or with mild exertion - Dizziness or syncope - Orthopnea or paroxysmal nocturnal dyspnea - Ankle edema - Palpitations or tachycardia - Intermittent claudication - heart murmur - Unusual fatigue or shortness of breath with usual activity (ACSM Cardiovascular Risk Assessment)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups

Dynamic cycling

Experimental group

Description:

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.

Treatment:

Other: Dynamic cycling

Forced cycling

Active Comparator group

Description:

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.

Treatment:

Other: Forced cycling