Speed Manipulated Adaptive Rehabilitation Therapy Bike for Parkinson's Disease (SMART)
Effects of Patient-Specific Adaptive Dynamic Cycling on Function Improvement in Individuals With Parkinson's Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Angela L Ridgel, PhD
- Phone Number: 330-672-7495
- Email: aridgel@kent.edu
Study Locations
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Ohio
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Kent, Ohio, United States, 44242
- Recruiting
- Kent State University
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Contact:
- Ridgel Angela, PhD
- Phone Number: 330-672-7495
- Email: aridgel@kent.edu
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Sub-Investigator:
- Smith Brittany
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Sub-Investigator:
- Shigo Lara
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Sub-Investigator:
- Shaikh Aasef
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Sub-Investigator:
- Joshi Prajakta
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Adaptive dynamic cycling
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.
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Resistance settings will be changed based on entropy of cadence every 3 sessions.
Cadence will be set at 80RPM for both groups
Other Names:
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Active Comparator: Non-adaptive dynamic cycling
For the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol.
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Resistance settings will be changed based on entropy of cadence every 3 sessions.
Cadence will be set at 80RPM for both groups
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in motor symptoms
Time Frame: 4 weeks
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MDS-UPDRS Motor III (Movement Disorders Society- Unified Parkinson's Disease Rating Scale) Minimum Score-0 Maximum Score- 138 Lower score represents improvement
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4 weeks
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Change in motor kinematics
Time Frame: 4 weeks
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Kinesia One- Accelerometry- Lower score represents milder symptoms
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in quality of life
Time Frame: 4 weeks
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PDQ-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
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4 weeks
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Change in mobility
Time Frame: 4 weeks
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Timed up and Go- Total time reported, lower time represents greater mobility
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4 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in mood
Time Frame: 4 weeks
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Mood scales
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4 weeks
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Change in affect
Time Frame: 4 weeks
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Affective scales
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4 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Harper SA, Dowdell BT, Kim JH, Pollock BS, Ridgel AL. Non-Motor Symptoms after One Week of High Cadence Cycling in Parkinson's Disease. Int J Environ Res Public Health. 2019 Jun 14;16(12):2104. doi: 10.3390/ijerph16122104.
- Mohammadi-Abdar H, Ridgel AL, Discenzo FM, Loparo KA. Design and Development of a Smart Exercise Bike for Motor Rehabilitation in Individuals with Parkinson's Disease. IEEE ASME Trans Mechatron. 2016 Jun;21(3):1650-1658. doi: 10.1109/TMECH.2015.2508030. Epub 2015 Dec 11.
- Ridgel AL, Ault DL. High-Cadence Cycling Promotes Sustained Improvement in Bradykinesia, Rigidity, and Mobility in Individuals with Mild-Moderate Parkinson's Disease. Parkinsons Dis. 2019 Mar 3;2019:4076862. doi: 10.1155/2019/4076862. eCollection 2019.
- Mohammadi-Abdar H, Ridgel AL, Discenzo FM, Phillips RS, Walter BL, Loparo KA. Test and Validation of a Smart Exercise Bike for Motor Rehabilitation in Individuals With Parkinson's Disease. IEEE Trans Neural Syst Rehabil Eng. 2016 Nov;24(11):1254-1264. doi: 10.1109/TNSRE.2016.2549030. Epub 2016 Mar 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMARTPD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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