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

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 cycling
    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.
  • Active Comparator: Forced cycling
    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.

Primary Outcome Measure

Intensity of abnormal movements measured with wearable sensors (acceleorometers) [ Time Frame: Four week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Louis Stokes VA Medical Center, Cleveland, OHClevelandOhio44106-1702
Holly B Henry
216-791-3800
Aasef G. Shaikh, MD PhD (PRINCIPAL_INVESTIGATOR)

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