SCH: Context-aware Freezing of Gait Mitigation in Real-world Setting

People with Parkinson's disease (PD) may experience a walking problem called freezing of gait (FoG) that can interfere with the person's ability to conduct daily activities. FoG has been described as feeling like one's feet are glued or stuck to the floor. Drug treatments for PD rarely improve FoG. Researchers have found that vibration therapy may help improve FoG. The purpose of this research study is to test the safety, tolerability, and effectiveness of using a wearable device (UG motion sensor, that is the size of a watch) that will recognize FoG and then send a signal to another small watch-like device (PDVibe3) to deliver a vibration stimuli to participant's feet. The researchers believe the vibration stimulus (which feels like a phone on vibration mode) will help reduce FoG in persons with PD. The study is open to people who have been diagnosed with Parkinson's disease, have FoG, and meet the study entry requirements.

The PDVibe3 is an investigational device, which means it has not been approved by the U.S. Food and Drug Administration (FDA). The UG motion sensor is also an investigational device.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: UG motion sensor with PDVibe3

Detailed Description

Usual care for PD involves taking medications to help with disease. In this study, participants will receive usual care. Participants will be asked to have taken their medication before they arrive, and to bring extra medicine with them should their next dose be due while they are at the study site.

Participants will be asked to walk on certain paths, and when the device detects a freeze in their gait, they will receive a dose of vibration to their feet. This vibration is felt differently by different people and it may feel very light or a little stronger (like a phone set to vibrate), or it may feel somewhere in between.

During the study, participants will be asked to do the following things:

1. Visit the research site at VCU, one time for the study
2. Complete a short cognitive exam
3. Answer questions about their medical history
4. Complete a few brief surveys about fatigue, balance, falls, freezing of gait, quality of life, and activities of daily living
5. Complete a 10-meter walk test
6. Wear the UG motion sensor (which detects FoG) on each ankle
7. Wear the PDVibe3 (which provides vibration) on each ankle

8. Walk five, 5-meter scenarios without vibration, and then again three more times with vibration therapy in a public setting on VCU campus. The five scenarios include:

   1. Walking through a narrow passage
   2. Walk and turn 540 degrees
   3. Walk toward a chair
   4. Walk while performing a verbal task
   5. Walk through a door before it closes

Participants will be able to take breaks at any time if they feel tired. Participants will be photographed and videotaped during the walking sessions, but faces will be blurred so that the recordings will not be identifiable.

Participation in this study can last up to 5 hours with several breaks. Approximately 20 individuals will participate in this study.

• Study Type: Interventional
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion

• age >18 years,
• Parkinson's disease (PD) diagnosed by a movement disorder specialist using UK Brain Bank criteria,
• are able to walk independently or with a simple device (e.g., cane or walker), and
• are observed by the research team to have PD-related FoG in at least two of the five previously described common trigger scenarios (i.e., freezing upon gait initiation, walking through tight quarters, freezing when changing directions, approaching a visual target, dual tasking, and stressful, time sensitive situations such as entering an elevator before the doors close).

Exclusion

• individuals with known Parkinson plus syndrome,
• presence of dementia (Montreal Cognitive Assessment < 21),
• an additional disorder (not related to PD) impairing gait,
• history of implantable cardiac device or any other implanted electronic device except DBS,
• peripheral neuropathy (determined by use of tuning fork to check for ability to feel vibration),
• any condition that, in the opinion of the PI, would compromise participant safety, data integrity, or data interpretation,
• pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibration therapy; 5-meter walk scenarios with vibration therapy	Device: UG motion sensor with PDVibe3; UG motion sensor (which detects FoG) on worn each ankle. PDVibe3 (which provides vibration) on worn each ankle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Freezing of Gait (FoG) Episodes	Participants will be videotaped during each walking task and the number of FoG episodes will be counted. Change in number of FoG episodes will be calculated by subtracting the average number of FoG episodes while experiencing vibration vs the number of episodes without vibration. For this test, the null hypothesis of no difference between the treatments versus the alternative hypothesis that the two groups differed.	Baseline to final walk task - up to 5 hours
Duration of Freezing of Gait (FoG) Episodes.	Participants will be videotaped during each walking task and the duration of each FoG episodes will be calculated. Change in duration of FoG episodes will be calculated by subtracting the average duration of FoG episodes while experiencing vibration vs the average duration without vibration.	Baseline to final walk task - up to 5 hours

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): March 10, 2025
• Study Completion (Actual): March 10, 2025

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Freezing of Gait
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: HM20020085; R01NS120560 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO