Clinical trial NCT05298150: Remote Dynamic Cycling for the Customized Off-site Rehab in Parkinson's Disease
Official title: Remote Dynamic Cycling for the Customized Off-site Rehab in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Stationary bike
Exercise
Rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-03-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Exercise intervention
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Intensity of abnormal movements measured with wearable sensors (acceleorometers)
timeFrame: Four week
Secondary outcomes:
measure: Montreal Cognitive Assessment Scale
timeFrame: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention
measure: Berg Balance test
timeFrame: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention
measure: Mini Balance Evaluation System Test
timeFrame: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention
measure: Activity-specific Balance Confidence scale
timeFrame: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: Louis Stokes VA Medical Center, Cleveland, OH
name: Aasef G. Shaikh, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: