What this study is
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.
What's being tested
- Smartshoes with haptic vibration feedback
Intervention · DEVICE
wearable smartshoe with capability to deliver haptic/vibration feedback to assess effect on freezing of gait
Study details
- Official title
- Mitigating Freezing of Gait (FoG) in Parkinson's Disease With Spatiotemporal Haptic Feedback Delivered by Smartshoes
- Sponsor
- Stanford University
- Conditions
- Parkinson Disease
- Enrolling
- 20 people
- Starts
- 2026-09
- Est. completion
- 2027-09
- Design
- Triple-blind, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years – 80 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openStanford University
Palo Alto, California, United States
Study team
Sponsor
Stanford University
Study ID 79809
Principal investigator
Hengameh Zahed, MD, PhD
Stanford University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.