Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702, United States
NCT Number: NCT05298150
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44106-1702, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Diagnosis of PD using the UK Brain Bank criteria
Exclusion criteria
The dynamic cycling involves smart bike that changes according to participants' performance.
The same smart bike as used for dynamic cycling, but its adaptive capacity will be disabled. In this case, the bike will behave as standard exercise stationary bike. It will not change its performance according to participants' response.
Time frame: Four week
Both sensor outcomes will be transmitted to the laboratory, via secure cloud, for further analysis. The analysis is comprised of looking at change in abnormal movements in response to exercise (cycling) intervention. The change in parameters will be used to further adjust exercise paradigm, if subjects are in dynamic cycling group.
The wearable sensors are non-invasive and highly tolerable.
Time frame: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention
We will examine total score of cognitive outcome measure with Montreal Cognitive Assessment Scale before intervention, immediately after (at 4 weeks), 3 months, and 6 months. We will track whether there is any change in the total score after intervention (at mentioned intervals) compared to before intervention. The range of Montreal Cognitive Assessment Scale is between 0 (worst) and 30 (best, that is normal). This is standard and highly tolerable rating scale frequently used in various clinical trials and clinical practice.
Time frame: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention
Measure balance outcome measures with Berg Balance test at 0 (i.e., at week 4), 3, and 6 months after the exercise and compare them with pre-exercise baseline. This balance outcome measure depicts change in postural instability in response to exercise regimen, immediately after completion (4 weeks) and at 3 and 6 months. The range is between 0 (worst) and 56 (best, normal). This is standard and highly tolerable rating scale frequently used in various clinical trials and clinical practice.
Time frame: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention
Measure balance outcome measures will be done with Mini Balance Evaluation System Test. It will be done before intervention and at the time of completion of exercise intervention 0 month (4 weeks) and at 3 and 6 month follow up. Post-exercise scores will be compared with pre-exercise baseline. The balance outcome measure depicts change in postural instability and balance in response to exercise regimen. The score ranges between 0 (worst) and 28 (best, normal). This is standard and highly tolerable rating scale frequently used in various clinical trials and clinical practice.
Time frame: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention.
Measure balance function will be performed with Activity-specific Balance Confidence scale. This measure will be performed immediately before the exercise intervention, and after 0 month (at 4 weeks) and at 3 month and 6 months after the exercise and compare them with pre-exercise baseline. The balance outcome measure depicts change in balance function and postural instability in response to exercise regimen. The score ranges from 0 (worst) and 100 (best, normal). This is standard and highly tolerable rating scale frequently used in various clinical trials and clinical practice.
VA Office of Research and Development
Fed
Acronym: PDBIKE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03808675
Adherence Interventions, Basal Ganglia Diseases
Iowa City, Iowa, United States
View Trial DetailsNCT02598973
Basal Ganglia Diseases, Behavior
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT05485428
Basal Ganglia Diseases, Behavior
Plymouth, Devon, United Kingdom
View Trial DetailsNCT05575479
Basal Ganglia Diseases, Behavior
Columbus, Ohio, United States
View Trial Details