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

NCT04746846 | Completed Results

• 2 other identifiers: HM20020085R01NS120560
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Freezing of Gait

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Vibration therapy

EXPERIMENTAL

5-meter walk scenarios with vibration therapy

Device: UG motion sensor with PDVibe3

Interventions

UG motion sensor with PDVibe3 DEVICE

UG motion sensor (which detects FoG) on worn each ankle. PDVibe3 (which provides vibration) on worn each ankle

Vibration therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Ingrid Pretzer-Aboff, Ph.D., RN , FGSA, FAAN
• Organization: Virginia Commonwealth University

iaboff@vcu.edu

804-828-3340

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 10, 2021
• Study Start: June 11, 2021
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)