Speed Manipulated Adaptive Rehabilitation Therapy Bike for Parkinson's Disease

NCT05361200 | Recruiting

• 1 other identifier: SMARTPD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

movement disorders; exercise; adaptive therapy; cycling

Outcome Measures

Primary Outcomes (2)

• 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

  4 weeks

• Change in motor kinematics

  Kinesia One- Accelerometry- Lower score represents milder symptoms

  4 weeks

Secondary Outcomes (2)

• Change in quality of life

  4 weeks

• Change in mobility

  4 weeks

Other Outcomes (2)

• Change in mood

  4 weeks

• Change in affect

  4 weeks

Study Arms (2)

Adaptive dynamic cycling

EXPERIMENTAL

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.

Behavioral: Dynamic high-cadence cycling

Non-adaptive dynamic cycling

ACTIVE COMPARATOR

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

Behavioral: Dynamic high-cadence cycling

Interventions

Dynamic high-cadence cycling BEHAVIORAL

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

Also known as: S.M.A.R.T. cycling

Adaptive dynamic cycling; Non-adaptive dynamic cycling

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic Parkinson's disease
• years of age
• no contraindications to exercise including cardiovascular disease or stroke

You may not qualify if:

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

Sponsors & Collaborators

• Kent State University: lead

Study Sites (1)

Kent State University

Kent, Ohio, 44242, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 31197095 RESULT

• 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.

  PMID: 27298575 RESULT

• 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.

  PMID: 30944720 RESULT

• 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.

  PMID: 27046905 RESULT

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Behavior

Central Study Contacts

Angela L Ridgel, PhD

CONTACT

330-672-7495; aridgel@kent.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will not be told which group they were assigned to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Health Sciences

Model Details: Randomized controlled study with 2 arms

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: May 4, 2022
• Study Start: April 11, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)