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NCT Number: NCT07001072

Smartshoes for Freezing of Gait in 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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartshoes with haptic vibration feedback

Device

wearable smartshoe with capability‬ to deliver haptic/vibration feedback to assess effect on freezing of gait

Other names: NUSHU research

Primary outcomes

  1. Participant device tolerance survey score

    Time frame: immediately after completion of walking tasks on day 1

  2. Total duration of freezing episodes

    Time frame: Baseline, and day 1 during each walking task (2 min per assessment)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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