A Novel Instrument to Address Freezing of Gait in Parkinson's Patients
Barron Associates, Inc.
Summary
The goal of this clinical trial is to learn if the ParkinSense system, a customizable, multimodal, and adaptable cueing system, can assist with freezing of gait (FOG) in patients with Parkinson's disease. The main question it aims to answer is: is the percent of time spent frozen reduced when using the system compared to not using the system? Participants will be asked to take part in a single-visit laboratory study where they will wear the system in a controlled environment, followed by a two weeks of home use.
Description
The ParkinSense instrument will be evaluated in a clinical trial with a laboratory and a home component. The study protocol involves two clinic visits. The first visit will involve consent and screening. The laboratory protocol will also take place during the this visit. The home-based protocol will follow the laboratory protocol. After the home protocol, the participant will return a final time to drop off the unit and complete the follow-up interview/questionnaires. -Laboratory Protocol. The purpose of the laboratory protocol will be to evaluate the ParkinSense instrument in a controlled se…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed diagnosis of idiopathic Parkinson's Disease * Prior identified presence of Freezing of Gait * Ability to ambulate; * Montreal Cognitive Assessment (MOCA) MOCA questionnaire score \>=21. Exclusion Criteria: * Peripheral neuropathy * Dementia * Severe gait abnormalities not related to Parkinson's Disease.
Interventions
- DeviceParkinSense System
The noninvasive, body-worn ParkinSense system is intended help patients with Parkinson's prevent freezing of gait (FOG) and resume ambulation when FOG occurs. The system provides multiple modes of cueing, offers extensive cue personalization, and automatically detects FOG and issues one or more cues that have been tailored to an individual when FOG is detected.
Location
- University of VirginiaCharlottesville, Virginia