Smartshoes for Freezing of Gait in Parkinson's Disease (NCT07001072) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Smartshoes for Freezing of Gait in Parkinson's Disease
United States20 participantsStarted 2026-09
Plain-language summary
This is a pilot research study aimed at evaluating whether an FDA listed wearable shoe with capability to deliver vibration feedback can be safe and tolerable for patients with Parkinson disease and control participants and explore whether such a feedback can be useful for treating freezing of gait (FOG) in patients with Parkinson disease.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For patients with Parkinson disease:
* diagnosis of PD according to the UK Brain Bank criteria
* Hoehn and Yahr stages 2 to 3 during the ON phase of PD medication
* Self-report episodes of FoG based on item 1 of the NFOG-Q, and score of 3 on item 2, part II
For patients with Parkinson disease withOUT freezing of gait:
* diagnosis of PD according to the UK Brain Bank criteria
* Hoehn and Yahr stages 2 to 3 during the ON phase of PD medication
For all participants (PD with or without freezing, or age-matched controls):
* adult age 40-80
* able to walk 10 minutes at baseline
* able to provide consent
* able to read and write in English at an 8th grade level.
Exclusion Criteria:
For all participants (PD with or without freezing, or age-matched controls)
* moderate to severe peripheral neuropathy (based on self report or clinical exam using vibration tuning fork) which may limit ability to sense the vibratory feedback
* use of orthotics incompatible with the haptic wearable shoes
* severe balance deficits or daily falls at baseline
* patients with dementia (MoCA\<18) who are not able to appropriately provide consent for the study
* pregnant persons
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participant device tolerance survey score
Timeframe: immediately after completion of walking tasks on day 1
2
Total duration of freezing episodes
Timeframe: Baseline, and day 1 during each walking task (2 min per assessment)