Freezing of Gait Symptoms in Parkinson DiseaseNCT07542743
A System to Help With Freezing of Gait in Parkinson's Patients
A study testing ParkinSense System in people with Freezing of Gait Symptoms in Parkinson Disease, run by Barron Associates, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Freezing of Gait Symptoms in Parkinson Disease
- What is being tested?
- ParkinSense System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Peripheral neuropathy
- Dementia
- Severe gait abnormalities not related to Parkinson's Disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Connie Hoover contact
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
Clinical Research Coordinator, 434-358-9515, FDK5DN@uvahealth.org
About this study
Official title: 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.
Read the 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.
- Being tested
- ParkinSense System
- Keywords
- FOG, Freezing of Gait, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParkinSense SystemDevice
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 group | Role | What they receive |
|---|---|---|
| ParkinSense first, then Control | Experimental | 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. Receives: Device: ParkinSense System |
| Control first, then ParkinSense | Experimental | 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. Receives: Device: ParkinSense System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of time frozen
The total duration of annotated FOG events for that sequence divided by the total duration of the sequence.
Measured: Day 1 (during the laboratory visit)
Secondary outcomes (8)
Gait speed
Average gait speed (meters/second)
Measured: Day 1
Step Cadence
Average steps per second during each sequence
Measured: Day 1
Step cadence variability
The variability in step cadence for each sequence (steps/second)
Measured: Day 1
Average step length
The average step length for each sequence (meters).
Measured: Day 1
Activity level
Average activity level per day expressed in calories
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One time at the end of the participant's intervention week, assessed up to 2 weeks after study start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Freezing of Gait Symptoms in Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barron Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), University of Virginia
- Responsible party
- Sponsor
- Investigators
- Brian Clark, Principal investigator, Barron Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542743
- Sponsor's protocol ID
- ParkinSense1
- Other IDs
- R44AG074825
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Instrument to Address Freezing of Gait in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT07542743
- Acronym / sponsor ID
- ParkinSense1
- Keywords
- FOG, Freezing of Gait, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Barron Associates, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), University of Virginia
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ParkinSense first, then Control | Experimental | Device: ParkinSense SystemParticipants 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. |
| Control first, then ParkinSense | Experimental | Device: ParkinSense SystemParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Peripheral neuropathy
- Dementia
- Severe gait abnormalities not related to Parkinson's Disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParkinSense SystemThe 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. | Device | Control first, then ParkinSense, ParkinSense first, then Control |
Primary outcome
Percent of time frozen
Time frame: Day 1 (during the laboratory visit)
The total duration of annotated FOG events for that sequence divided by the total duration of the sequence.
8 secondary outcomes
Gait speed
Time frame: Day 1
Step Cadence
Time frame: Day 1
Step cadence variability
Time frame: Day 1
Average step length
Time frame: Day 1
Activity level
Time frame: Week 1 and week 2
Freezing of Gait Questionnaire (FOG-Q)
Time frame: Daily for 2 weeks of the home study
Parkinson's Disease Questionnaire results
Time frame: Week 1 and week 2
System Usability Scale (SUS) results
Time frame: One time at the end of the participant's intervention week, assessed up to 2 weeks after study start.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Connie Hoover contact
Brian Clark principal investigator
Barron Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ParkinSense System in people with Freezing of Gait Symptoms in Parkinson Disease, run by Barron Associates, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Clark (434-973-1215, clark1n@bainet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of time frozen (time frame: Day 1 (during the laboratory visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.