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Speed Manipulated Adaptive Rehabilitation Therapy Bike for Parkinson's Disease (SMART)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynamic high-cadence cycling
Sponsored by
Kent State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring movement disorders, exercise, adaptive therapy, cycling

Eligibility Criteria

50 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kent State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adaptive dynamic cycling

Non-adaptive dynamic cycling

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in motor symptoms
MDS-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 kinematics
Kinesia One- Accelerometry

Secondary Outcome Measures

Change in quality of life
PDQ-39 (Parkinson' disease quality of life, 39 questions) Minimum Score- 0 Maximum Score- 156
Change in mobility
Timed up and Go

Full Information

First Posted
March 21, 2022
Last Updated
May 3, 2022
Sponsor
Kent State University
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1. Study Identification

Unique Protocol Identification Number
NCT05361200
Brief Title
Speed Manipulated Adaptive Rehabilitation Therapy Bike for Parkinson's Disease
Acronym
SMART
Official Title
Effects of Patient-Specific Adaptive Dynamic Cycling on Function Improvement in Individuals With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kent State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
movement disorders, exercise, adaptive therapy, cycling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study with 2 arms
Masking
Participant
Masking Description
Participant will not be told which group they were assigned to
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adaptive dynamic cycling
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-adaptive dynamic cycling
Arm Type
Active Comparator
Arm Description
For the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol.
Intervention Type
Behavioral
Intervention Name(s)
Dynamic high-cadence cycling
Other Intervention Name(s)
S.M.A.R.T. cycling
Intervention Description
Resistance settings will be changed based on entropy of cadence every 3 sessions. Cadence will be set at 80RPM for both groups
Primary Outcome Measure Information:
Title
Change in motor symptoms
Description
MDS-UPDRS Motor III (Movement Disorders Society- Unified Parkinson's Disease Rating Scale) Minimum Score-0 Maximum Score- 138 Lower score represents improvement
Time Frame
4 weeks
Title
Change in motor kinematics
Description
Kinesia One- Accelerometry
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
PDQ-39 (Parkinson' disease quality of life, 39 questions) Minimum Score- 0 Maximum Score- 156
Time Frame
4 weeks
Title
Change in mobility
Description
Timed up and Go
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Change in mood and affect
Description
Mood and affective scales
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela L Ridgel, PhD
Phone
330-672-7495
Email
aridgel@kent.edu
Facility Information:
Facility Name
Kent State University
City
Kent
State/Province
Ohio
ZIP/Postal Code
44242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ridgel Angela, PhD
Phone
330-672-7495
Email
aridgel@kent.edu
First Name & Middle Initial & Last Name & Degree
Younguk Kim
First Name & Middle Initial & Last Name & Degree
Smith Brittany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31197095
Citation
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.
Results Reference
result
PubMed Identifier
27298575
Citation
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.
Results Reference
result
PubMed Identifier
30944720
Citation
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.
Results Reference
result
PubMed Identifier
27046905
Citation
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.
Results Reference
result

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Speed Manipulated Adaptive Rehabilitation Therapy Bike for Parkinson's Disease

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