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Smartshoes for Freezing of Gait in Parkinson's Disease
Smartshoes for Freezing of Gait in Parkinson's Disease

NCT07001072

Not Yet RecruitingNA

Sponsor: Stanford University

Conditions: Parkinson Disease

Interventions: Smartshoes with haptic vibration feedback

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
Locations (1)
  • Palo Alto, California, United States