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Behavioral Intervention

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

N/A

Recruiting

Research Sponsored by Kent State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Idiopathic Parkinson's disease

50-79 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

SMART Trial Summary

This trial will investigate how patient-specific settings for high-cadence cycling can improve functional performance in individuals with Parkinson's disease.

Who is the study for?

This trial is for individuals aged 50-79 with idiopathic Parkinson's disease who can safely exercise without the risk of cardiovascular or pulmonary complications. It aims to help those looking to improve their motor function and quality of life through a specialized cycling program.Check my eligibility

What is being tested?

The study tests dynamic high-cadence cycling, which means pedaling at a speed faster than one's natural pace, to see if it improves movement and functional performance in Parkinson's patients. Participants will cycle in 12 sessions over a month while being monitored for improvements.See study design

What are the potential side effects?

Since this intervention involves physical exercise, potential side effects may include muscle soreness, fatigue, and an increased risk of falls or injuries related to balance issues that are common in Parkinson’s disease.

SMART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Parkinson's disease.

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I am between 50 and 79 years old.

SMART Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in motor kinematics

Change in motor symptoms

Secondary outcome measures

Change in mobility

Change in quality of life

Other outcome measures

Change in affect

Change in mood

SMART Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adaptive dynamic cyclingExperimental Treatment1 Intervention

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 II: Non-adaptive dynamic cyclingActive Control1 Intervention

For the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kent State UniversityLead Sponsor

41 Previous Clinical Trials

6,553 Total Patients Enrolled

Media Library

Dynamic high-cadence cycling (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05361200 — N/A

Parkinson's Disease Research Study Groups: Adaptive dynamic cycling, Non-adaptive dynamic cycling

Parkinson's Disease Clinical Trial 2023: Dynamic high-cadence cycling Highlights & Side Effects. Trial Name: NCT05361200 — N/A

Dynamic high-cadence cycling (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05361200 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for enrolment in this experiment?

"Affirmative. According to the information found on clinicaltrials.gov, this medical experiment is currently enrolling participants; it was initially posted on April 11th 2022 and recently revised on May 3rd 2022. Forty patients are necessary for the study which is being conducted at one site only."

Answered by AI

Does this research encompass participants aged 30 or older?

"As stipulated in the criteria for admittance, this trial only accepts patients between 50 and 79 years of age."

Answered by AI

How many participants is the trial accommodating?

"Correct. According to clinicaltrials.gov, this medical research project is actively searching for 40 participants from one site; the listing was posted on April 11th 2022 and updated May 3rd 2022."

Answered by AI

Is it possible for me to become a participant in this clinical experiment?

"The present clinical trial is accepting a cohort of 40 elderly patients, aged between 50 and 79, who suffer from idiopathic Parkinson's disease. Preceding admission to the study, it must be confirmed that there are no contraindications for exercise due to cardiovascular disease or stroke."

Answered by AI

Recent research and studies

IEEE Transactions on Neural Systems and Rehabilitation EngineeringJournal

Test and Validation of a Smart Exercise Bike for Motor Rehabilitation in Individuals with Parkinson’s Disease

Mohammadi-Abdar, Hassan, Angela L. Ridgel, Fred M. Discenzo, Robert S. Phillips, Benjamin L. Walter, and Kenneth A. Loparo. 2016. “Test and Validation of a Smart Exercise Bike for Motor Rehabilitation in Individuals with Parkinson’s Disease”. IEEE Transactions on Neural Systems and Rehabilitation Engineering. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/tnsre.2016.2549030.

IEEE/ASME Transactions on MechatronicsJournal

Design and Development of a Smart Exercise Bike for Motor Rehabilitation in Individuals with Parkinson's Disease

Mohammadi-Abdar, Hassan, Angela L. Ridgel, Fred M. Discenzo, and Kenneth A. Loparo. 2016. “Design and Development of a Smart Exercise Bike for Motor Rehabilitation in Individuals with Parkinson's Disease”. IEEE/ASME Transactions on Mechatronics. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/tmech.2015.2508030.

Parkinson's DiseaseJournal

High-cadence Cycling Promotes Sustained Improvement in Bradykinesia, Rigidity, and Mobility in Individuals with Mild-moderate Parkinson’s Disease

Ridgel, Angela L., and Dana L. Ault. 2019. “High-cadence Cycling Promotes Sustained Improvement in Bradykinesia, Rigidity, and Mobility in Individuals with Mild-moderate Parkinson’s Disease”. Parkinson's Disease. Hindawi Limited. doi:10.1155/2019/4076862.

International Journal of Environmental Research and Public HealthJournal