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Smartshoes for Freezing of Gait in Parkinson's Disease

Mitigating Freezing of Gait (FoG) in Parkinson's Disease With Spatiotemporal Haptic Feedback Delivered by Smartshoes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether shoes that give vibration signals are safe and comfortable to use. It also looks at whether the signals help with freezing of gait, when a person’s feet feel stuck while walking. The study is for adults ages 40–80 with Parkinson’s disease, with or without freezing, and adults of similar ages without Parkinson’s disease.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 40–80 years old.
  • Be able to walk for 10 minutes at the start of the study.
  • Be able to understand and agree to join the study.
  • Be able to read and write in English at an 8th-grade level.
  • For Parkinson’s groups: have a Parkinson’s diagnosis that meets the UK Brain Bank rules.
  • For Parkinson’s groups: have disease at stage 2 or 3 on the Hoehn and Yahr scale while medicine is working.
  • For the freezing group: report freezing on question 1 of the NFOG-Q walking survey and score 3 on question 2, part II.

Who can't join

  • Have moderate to severe nerve damage in the feet or legs that may make it hard to feel the shoe vibrations.
  • Use shoe inserts or braces that do not work with the study shoes.
  • Have severe balance problems or fall every day at the start of the study.
  • Have dementia, with a score below 18 on the MoCA thinking and memory test, and be unable to understand and agree to join.
  • Be pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

CA