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

NCT ID: NCT04746846

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-11
• Study Completion Date: 2025-03-10

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.

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Vibration therapy

5-meter walk scenarios with vibration therapy

Group Type: EXPERIMENTAL

UG motion sensor with PDVibe3

Intervention Type: DEVICE

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

Interventions

UG motion sensor with PDVibe3

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01NS120560

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20020085

Identifier Type: -

Identifier Source: org_study_id