A System to Help With Freezing of Gait in Parkinson's Patients

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Barron Associates, Inc.
Study ID
NCT07542743
Status
Not Yet Recruiting

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Conditions

  • Freezing of Gait Symptoms in Parkinson Disease

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ParkinSense System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: ParkinSense first, then Control
    Participants will perform the FOG-inducing protocol first wearing the ParkinSense instrument, and then again without wearing it. During the home study, participants will first wear the ParkinSense instrument for one week, and then not wear the ParkinSense instrument for one week.
  • Experimental: Control first, then ParkinSense
    Participants will perform the FOG-inducing protocol first without wearing the ParkinSense instrument, and then while wearing the system. During the home study, participants will first not wear the ParkinSense instrument for one week, and then wear the ParkinSense instrument for the second week.

Primary Outcome Measure

Percent of time frozen [ Time Frame: Day 1 (during the laboratory visit) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Clinical Research Coordinator
[email protected]
434-358-9515

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By research site
University of Virginia· Charlottesville, VA

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