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Speed Manipulated Adaptive Rehabilitation Therapy Bike for Parkinson's Disease

Effects of Patient-Specific Adaptive Dynamic Cycling on Function Improvement in Individuals With Parkinson's Disease

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05361200
Acronym
SMART
Enrollment
40
Registered
2022-05-04
Start date
2022-04-11
Completion date
2024-12-31
Last updated
2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

movement disorders, exercise, adaptive therapy, cycling

Brief summary

Parkinson's disease (PD) is a progressive neurological disorder that results in slowness of movement, muscle stiffness, tremor, and postural instability. These symptoms significantly affect PD patients' quality of life, independence, and functional performance. There is currently no cure for PD, but symptoms can be treated with levodopa or deep brain stimulation surgery. Exercise-based rehabilitation has similar beneficial effects to surgical and pharmacological management without the potential negative side effects. Cycling-based interventions have been shown to increases motor function and mobility in individuals with PD. Specifically, benefits are greater when cycling cadence (revolutions per minute, RPM) is 30% greater than a self-selected pace. Although high cadence cycling improves motor function in individuals with PD, there is significant heterogeneity in individual responses. To maximize the treatment effects and minimize the heterogeneity of high-cadence cycling, it is important to determine patient-specific settings. Previous studies have shown that higher variability (entropy) of cadence leads to greater improvement in motor function. The entropy of cadence calculation will be utilized to understand how patient-specific settings can drive improvements. The purpose of this study is to determine patient-specific settings and measure the effects of high cadence stationary (i.e. dynamic) cycling on functional performance in individuals with PD. Volunteers with Parkinson's disease will complete 12 cycling sessions over a 1-month period and measures of motor function, quality of life, functional performance, mood and exercise readiness will be collected.

Detailed description

Potential participants will be prescreened with the ACSM pre-participation questionnaire over the phone or in person. Those who qualify will be asked to visit the research lab and sign the informed consent. Participants will be randomized into one of two groups: 1) patients-specific adaptive dynamic cycling or 2) non-adaptive dynamic cycling. Both groups will participate in a total of 12 sessions, each session consisting of 5 minutes of warm-up, 30 minutes of the main exercise, and 5 minutes of the cool-down period. For the patient-specific adaptive dynamic cycling group, the optimization process will be done after the 3rd, 6th, and 9th sessions. The optimization procedure is based on sample entropy of cadence calculation from the previous session's cycling performance. After optimization, participants will receive specific settings for the next session. For the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol.

Interventions

BEHAVIORALDynamic high-cadence cycling

Resistance settings will be changed based on entropy of cadence every 3 sessions. Cadence will be set at 80RPM for both groups

Sponsors

Kent State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participant will not be told which group they were assigned to

Intervention model description

Randomized controlled study with 2 arms

Eligibility

Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

* Idiopathic Parkinson's disease * 50-79 years of age * no contraindications to exercise including cardiovascular disease or stroke

Exclusion criteria

* one or more major signs/symptoms of cardiovascular or pulmonary disease

Design outcomes

Primary

MeasureTime frameDescription
Change in motor symptoms4 weeksMDS-UPDRS Motor III (Movement Disorders Society- Unified Parkinson's Disease Rating Scale) Minimum Score-0 Maximum Score- 138 Lower score represents improvement
Change in motor kinematics4 weeksKinesia One- Accelerometry- Lower score represents milder symptoms

Secondary

MeasureTime frameDescription
Change in quality of life4 weeksPDQ-39 (Parkinson' disease quality of life, 39 questions) Dimension score = sum of scores of each item in the dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100. Lower score reflect better QOL Minimum Score- 0 Maximum Score- 156
Change in mobility4 weeksTimed up and Go- Total time reported, lower time represents greater mobility

Other

MeasureTime frameDescription
Change in mood4 weeksMood scales
Change in affect4 weeksAffective scales

Countries

United States

Contacts

Primary ContactAngela L Ridgel, PhD
aridgel@kent.edu330-672-7495

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026