Speed Manipulated Adaptive Rehabilitation Therapy Bike for Parkinson's Disease

NCT ID: NCT05361200

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-11
• Study Completion Date: 2024-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dynamic high-cadence cycling

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Dynamic high-cadence cycling

Intervention Type: BEHAVIORAL

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

Interventions

Dynamic 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

Intervention Type: BEHAVIORAL

Other Intervention Names

S.M.A.R.T. cycling

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kent State University

OTHER

Sponsor Role: lead

Responsible Party

Angela Ridgel

Professor, School of Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kent State University

Kent, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Angela L Ridgel, PhD

Role: CONTACT

aridgel@kent.edu

330-672-7495

Facility Contacts

Ridgel Angela, PhD

Role: primary

aridgel@kent.edu

330-672-7495

References

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.

Reference Type: RESULT

PMID: 31197095 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27298575 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30944720 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27046905 (View on PubMed)

Other Identifiers

SMARTPD

Identifier Type: -

Identifier Source: org_study_id