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Not yet recruiting NCT07001072

Smartshoes for Freezing of Gait in Parkinson's Disease

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smartshoes with haptic vibration feedback.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Participant device tolerance survey score [Time frame: immediately after completion of walking tasks on day 1]
  • Total duration of freezing episodes [Time frame: Baseline, and day 1 during each walking task (2 min per assessment)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Palo Alto

Identifiers

NCT: NCT07001072 · 79809

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗