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

A Novel Instrument to Address Freezing of Gait in Parkinson's Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Freezing of Gait Symptoms in Parkinson Disease
• Intervention / Treatment: Device: ParkinSense System

Detailed 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 setting with respect to freezing of gait (FOG) prevalence and physical capacity metrics (viz., gait speed, step cadence, step cadence variability, and average step length).

Consented participants will be shown the ParkinSense instrument, and its function and purpose will be fully explained. Participants will then perform a trial run of the protocol, with guidance from study personnel, to familiarize them with ParkinSense and to allow the cue presentation to be initially personalized. When the participant is satisfied with the operation of ParkinSense, the study will proceed with the protocol discussed below.

The study protocol is designed to elicit FOG. The protocol will consist of the following activities: (1) a timed-up-and-go (TUG) test where the patient will sit in a chair, get up (without verbal prompting), walk 3 m, turn 180 degrees, walk back (as rapidly as possible in both directions), and then sit down in the chair; (2) a cognitive TUG (C-TUG), where the patient will perform a TUG while counting backwards by 3 starting from a random number provided by the PT; (3) a manual TUG (M-TUG), where the patient will perform a TUG while carrying a cup of water on a tray; and (4) the participant will be asked to walk through several doorways of different sizes and into a small room, turn 360 degrees from standstill, and then walk back through the doorways again.

Participants will perform the same protocol twice after the trial run, once while wearing the ParkinSense instrument and once without wearing the system. The order of the test (ParkinSense vs. no ParkinSense) will be randomized in a crossover design. The trials will be video recorded for FOG event and duration scoring. In order to collect the gait parameters of interest, participants will be asked to wear commercial gait tracking insoles during the study. Once the protocol has been completed, the participant's ParkinSense instrument will be packed into its carrying case, and the participant will be instructed regarding the home-based component.

-Home-based Protocol. The purpose of the home-based study component is to provide patients with real-world use experience, inform refinements and enhancements to the ParkinSense device, ascertain usability and user-acceptance of the Phase II prototype, and compare overall activity levels of participants when the ParkinSense is being used vs. when it is not being used. Participants will be provided a ParkinSense system and a research-grade activity tracker for this two-week field trial. They will have been trained regarding proper use of the ParkinSense device by study personnel under the Laboratory Protocol.

Participants will use ParkinSense during awake hours for one week, and refrain from using the system during the alternate week. The week chosen to use the ParkinSense system will be randomized in a crossover design similar to the laboratory component. The time spent wearing the system will be tracked. Participants will be asked to use the activity tracker for both weeks in order to track activity throughout the study.

Participants will complete the Freezing of Gait Questionnaire (FOG-Q) and a Hauser Parkinson's Disease Diary daily for the duration of the at-home study (alternatively, a caretaker can fill out the forms with the patient's input). Participants will complete the Parkinson's Disease Questionnaire (PDQ-8) at the end of each week. At the completion of the study, participants will be interviewed and asked to complete the System Usability Scale.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian Clark; Phone Number: 434-973-1215; Email: clark1n@bainet.com
• Study Contact Backup: Name: Connie Hoover; Phone Number: 434-973-1215

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
      • Contact: Clinical Research Coordinator; Phone Number: 434-358-9515; Email: FDK5DN@uvahealth.org

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: ParkinSense 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.
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.	Device: ParkinSense 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of time frozen	The total duration of annotated FOG events for that sequence divided by the total duration of the sequence.	Day 1 (during the laboratory visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait speed	Average gait speed (meters/second)	Day 1
Step Cadence	Average steps per second during each sequence	Day 1
Step cadence variability	The variability in step cadence for each sequence (steps/second)	Day 1
Average step length	The average step length for each sequence (meters).	Day 1
Activity level	Average activity level per day expressed in calories	Week 1 and week 2
Freezing of Gait Questionnaire (FOG-Q)	Freezing of Gait Questionnaire results to assess participant subjective FOG experience. Scores range from 0 to 24, with 24 indicating more severe freezing of gait.	Daily for 2 weeks of the home study
Parkinson's Disease Questionnaire results	Parkinson's Disease Questionnaire results after each week to assess quality of life. Scores range from 0 to 32 with lower scores indicating a higher quality of life.	Week 1 and week 2
System Usability Scale (SUS) results	System Usability Score results to assess usability of ParkinSense in a home environment. Measured once per participant after the intervention week; the timing of the intervention week varies by sequence in this crossover design. Scores range from 0 to 100 with 100 indicating the highest ease of use.	One time at the end of the participant's intervention week, assessed up to 2 weeks after study start.

Collaborators and Investigators

• Sponsor: Barron Associates, Inc.
• Collaborators: National Institute on Aging (NIA); University of Virginia
• Investigators: Principal Investigator: Brian Clark, Barron Associates

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Freezing of Gait; FOG
• 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: ParkinSense1; R44AG074825 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No