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New wearable device helps Parkinson's patients unfreeze their steps

NCT ID NCT06385392

Symptom relief Sponsor: HealthPartners Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a wearable system (a haptic module and insole device) designed to detect freezing of gait in people with Parkinson's disease and then trigger cues to help them start walking again. The study enrolled 31 participants and aimed to validate the device's performance in daily, in-community use. The main goal was to see if the device could reduce the duration of freezing episodes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
haptic module and insole device
What this could lead to
If it works, this could provide a practical, daily-use tool to help people with Parkinson's walk more freely by reducing episodes of freezing.
What could go wrong
This is a small, early-stage study with only 31 participants. The device may not work well for everyone, and long-term benefits or safety outside a lab setting are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

31 people

The number who actually took part.

Started

Sep 2024

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants aged 45-80 who have a diagnosis of Parkinson's disease with Freezing of Gait symptoms who live in the community.

Ages

45 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

Contacts and locations

Locations

  • HealthPartners Neuroscience Center

    Saint Paul, Minnesota, 55130, United States

  • Struthers Parkinson's Center

    Golden Valley, Minnesota, 55427, United States

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