Status:
NOT_YET_RECRUITING
Smartshoes for Freezing of Gait in Parkinson's Disease
Lead Sponsor:
Stanford University
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief 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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07001072
Start Date
September 1 2025
End Date
September 1 2026
Last Update
June 3 2025
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 94305