Parkinson Disease
Conditions
Keywords
freezing of gait
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 control participants and explore whether such a feedback can be useful for treating freezing of gait (FOG) in patients with Parkinson disease.
Interventions
DEVICESmartshoes with haptic vibration feedback
wearable smartshoe with capability to deliver haptic/vibration feedback to assess effect on freezing of gait
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant device tolerance survey score | immediately after completion of walking tasks on day 1 |
| Total duration of freezing episodes | Baseline, and day 1 during each walking task (2 min per assessment) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHengameh Zahed, MD, PhD
Stanford University
Outcome results
None listed