Remote cycling rehabilitation for Parkinson's disease
Remote Dynamic Cycling for the Customized Off-site Rehab in Parkinson's Disease
This study is testing a new way for people with Parkinson's disease to do rehabilitation exercises on a stationary bike from home, using a virtual system that adjusts to their needs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05298150 on ClinicalTrials.gov |
What this trial studies
This research aims to develop an innovative and accessible method for delivering effective rehabilitation to individuals with Parkinson's disease through a remote dynamic cycling approach. The study will evaluate the efficacy of a stationary bike that can be monitored and adjusted in real-time via a virtual interface, allowing for customized rehabilitation tailored to each patient's needs. This approach addresses significant barriers to traditional rehabilitation, such as travel limitations and lack of resources, particularly benefiting veterans who may be home-bound. The technology has already shown promise in preliminary laboratory settings, and this study seeks to validate its effectiveness in a real-world context.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Parkinson's disease who are in Hoehn and Yahr stages I-III and can provide informed consent.
Not a fit: Patients with significant cognitive impairment, severe depression or anxiety, or untreated cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a cost-effective and personalized rehabilitation option for patients with Parkinson's disease, improving their motor function and quality of life.
How similar studies have performed: While this specific approach is novel, similar studies utilizing remote rehabilitation techniques have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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)
Where this trial is running
Cleveland, Ohio
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Aasef G. Shaikh, MD PhD — Louis Stokes VA Medical Center, Cleveland, OH
- Study coordinator: Aasef G Shaikh, MD PhD
- Email: Aasef.Shaikh@va.gov
- Phone: (216) 791-3800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.