Parkinson DiseaseNCT06385392
Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.
An observational study of Parkinson Disease, run by HealthPartners Institute at 2 sites in United States.
Trial summary
The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Haptic module and insole device
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2024to 28 Apr 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants aged 45-80 who have a diagnosis of Parkinson's disease with Freezing of Gait symptoms who live in the community.
Who may be able to join
- Ability to provide and provision of signed and dated informed consent form.
- Age 45 or older
- Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.
- Evidence of presence of freezing gait as a symptom. Determined from combination of clinical examination (observation of freezing) and New Freezing of Gait Questionnaire (NFOG).
- Able to complete a 2-minute walk test at the pre-treatment visit.
- Currently on a stable prescription medication regimen for PD and willing to adhere to the regimen during the study.
- Ability to don and doff the insole and haptic module independently or have daily assistance during the study intervention.
Who cannot join
- Non-English speaking
- History of musculoskeletal disorders that significantly affect movement of lower limbs as determined at the time of enrollment.
- Other significant neurological disorders that may affect participation or performance in the study.
- Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module.
- Hallucinations
- Non-ambulatory
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- Legally Blind
- Symptomatic hypotension
- Any condition which would limit sensation in the legs or requires use of wraps, bandages or other items which may limit sensation in the legs (e.g., lymphedema) that would interfere with the performance of the haptic device, in the opinion of the investigator.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130
About this study
The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing.
- Conditions
- Parkinson Disease
- Being tested
- Haptic module and insole device
- Keywords
- Freezing of Gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haptic module and insole deviceDevice
System for use in daily in-community use that detects the occurrence of freezing of gait (FOG) and triggers external cueing stimuli to unfreeze the individual.
| Study group | Role | What they receive |
|---|---|---|
| People with Parkinson's disease and Freezing of Gait using experimental insole and haptic module | Not described Receives: Device: Haptic module and insole device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Validate the Haptic Module and Insole Device System and Evaluate Its Efficacy With an In-community Clinical Trial.
Change in duration of FOG events. Decreased duration of FOG events indicates higher efficacy of device system.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start11 Sep 2024
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha A Nance, MD, Principal investigator, Struthers Parkinson's Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385392
- Sponsor's protocol ID
- A23-354
- Status last verified
- May 2026
- First submitted
- 22 Apr 2024
- Last updated
- 28 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.
- ClinicalTrials.gov ID
- NCT06385392
- Acronym / sponsor ID
- A23-354
- Conditions
- Parkinson Disease
- Keywords
- Freezing of Gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Posted 28 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with Parkinson's disease and Freezing of Gait using experimental insole and haptic module | – | Device: Haptic module and insole device |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants aged 45-80 who have a diagnosis of Parkinson's disease with Freezing of Gait symptoms who live in the community.
Key inclusion criteria (7 listed)
- Ability to provide and provision of signed and dated informed consent form.
- Age 45 or older
- Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.
- Evidence of presence of freezing gait as a symptom. Determined from combination of clinical examination (observation of freezing) and New Freezing of Gait Questionnaire (NFOG).
- Able to complete a 2-minute walk test at the pre-treatment visit.
Key exclusion criteria (9 listed)
- Non-English speaking
- History of musculoskeletal disorders that significantly affect movement of lower limbs as determined at the time of enrollment.
- Other significant neurological disorders that may affect participation or performance in the study.
- Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module.
- Hallucinations
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 |
|---|---|---|
| Haptic module and insole deviceSystem for use in daily in-community use that detects the occurrence of freezing of gait (FOG) and triggers external cueing stimuli to unfreeze the individual. | Device | People with Parkinson's disease and Freezing of Gait using experimental insole and haptic module |
Primary outcome
To Validate the Haptic Module and Insole Device System and Evaluate Its Efficacy With an In-community Clinical Trial.
Time frame: 5 weeks
Change in duration of FOG events. Decreased duration of FOG events indicates higher efficacy of device system.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Martha A Nance, MD principal investigator
Struthers Parkinson's Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by HealthPartners Institute at 2 sites 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 28 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Validate the Haptic Module and Insole Device System and Evaluate Its Efficacy With an In-community Clinical Trial. (time frame: 5 weeks). 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 28 May 2026.