Remote Dynamic Cycling for the Customized Off-site Rehab in Parkinson's Disease

NCT05298150 | Recruiting

• 2 other identifiers: E3676-R1I01RX003676-01A2
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This research will develop novel and accessible way to deliver effective and customized rehab to those suffering from common and devastating neurodegenerative condition called Parkinson's disease. The investigators will examine the efficacy of novel rehab technique that can be monitored and modified in real-time but over virtual interface using a remotely located device in a paradigm called dynamic cycling. This technology will benefit thousands of Veterans who need customized and cost-effective rehab but cannot travel to specialized facilities due to inevitable limitations such as pandemics or because of lack of resources, social support, frailty, or home-bound status.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Stationary bike; Exercise; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Intensity of abnormal movements measured with wearable sensors (acceleorometers)

  1. Before and after exercise sensing: Participants will perform finger taps, reaching, extending their arms, and hand opening and closing. As they do so, the investigators will measure their body movements, looking for abnormal involuntary movements, using wearable sensors comprised of accelerometers. Collected data will be used to determine improvement in involuntary movements. 2. 12 hour awake period sensing: Participants will wear sensor that looks like a 'wrist watch', and will spend their day in a normal way. Sensor will constantly sense and store their activity measures. Both sensor outcomes will be transmitted to the laboratory, via secure cloud, for further analysis. The analysis is comprised of looking at change in abnormal movements in response to exercise (cycling) intervention. The change in parameters will be used to further adjust exercise paradigm, if subjects are in dynamic cycling group. The wearable sensors are non-invasive and highly tolerable.

  Four week

Secondary Outcomes (4)

• Montreal Cognitive Assessment Scale

  before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention

• Berg Balance test

  before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention

• Mini Balance Evaluation System Test

  before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention

• Activity-specific Balance Confidence scale

  before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention.

Study Arms (2)

Dynamic cycling

EXPERIMENTAL

The cycling parameters will change according to motor performance of the participants. Motor performance will be measured by assessing the change in tremor and movement speed.

Other: Dynamic cycling

Forced cycling

ACTIVE COMPARATOR

The cycling parameters will not change regardless of the motor performance. Motor performance will be measured by assessing the change in tremor and movement speed.

Other: Forced cycling

Interventions

Dynamic cycling OTHER

The dynamic cycling involves smart bike that changes according to participants' performance.

Dynamic cycling

Forced cycling OTHER

The same smart bike as used for dynamic cycling, but its adaptive capacity will be disabled. In this case, the bike will behave as standard exercise stationary bike. It will not change its performance according to participants' response.

Forced cycling

Eligibility Criteria

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

You may qualify if:

• Diagnosis of PD using the UK Brain Bank criteria
• Ability to perform informed consent.
• Hoehn and Yahr (H\&Y) stages I-III when off medication,
• Stable medical regimen of antiparkinsonian medication for at least six months

You may not qualify if:

• Montreal Cognitive Assessment Scoreless than 18
• Hamilton depression score of 20 or higher
• Hamilton anxiety rating score greater than 24
• Clinical diagnosis including perinatal brain injury, stroke, and atypical parkinsonism
• One or more signs or symptoms of untreated cardiovascular disease including Pain, discomfort in the chest, neck, jaw, arms or other areas that may result from ischemia - Shortness of breath at rest or with mild exertion - Dizziness or syncope - Orthopnea or paroxysmal nocturnal dyspnea - Ankle edema - Palpitations or tachycardia - Intermittent claudication - heart murmur - Unusual fatigue or shortness of breath with usual activity (ACSM Cardiovascular Risk Assessment)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Aasef G. Shaikh, MD PhD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aasef G Shaikh, MD PhD

CONTACT

(216) 791-3800; Aasef.Shaikh@va.gov

Varun Sundaram, MBBS PhD

CONTACT

(216) 679-3800; varun.sundaram@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Two interventions are dynamic cycling and forced cycling. Participants will randomly assigned to one of the two interventions, and they will be kept blinded. Outcome assessment, such as subjective rating scale, behavioral rating scales, and quality of life assessment will be done in blinded fashion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Exercise intervention

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 28, 2022
• Study Start: April 1, 2022
• Primary Completion: March 31, 2026
• Study Completion: April 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)