Remote Dynamic Cycling for the Customized Off-site Rehab in Parkinson's Disease
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT05298150
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dynamic cycling — OTHERThe dynamic cycling involves smart bike that changes according to participants' performance.
- Forced cycling — OTHERThe 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.
Study Details
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.
Key Dates
- Start date
- Apr 1, 2022
- Status verified
- Jan 2026
- Primary completion
- Mar 31, 2026
- Completion
- Apr 1, 2026
Study Design
- Enrollment
- 72 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Dynamic cyclingThe 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.
- Active Comparator: Forced cyclingThe cycling parameters will not change regardless of the motor performance. Motor performance will be measured by assessing the change in tremor and movement speed.
Primary Outcome Measure
Intensity of abnormal movements measured with wearable sensors (acceleorometers) [ Time Frame: Four week ]
Central Contacts
- Aasef G Shaikh, MD PhD(216) 791-3800
- Varun Sundaram, MBBS PhD(216) 679-3800
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106-1702 | Aasef G. Shaikh, MD PhD (PRINCIPAL_INVESTIGATOR) |
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