Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-09-30
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Parkinson's disease with freezing episodes
Participants perform 3 walking tasks in random order: 1 with receiving vibrotactile feedback in swing-phase of gait, 1 with receiving vibrotactile feedback in metronome (regularly timed) vibration (set at low/medium/fast based on preferred/natural walking speed of the patient at baseline), and another with no vibration.
Smartshoes with haptic vibration feedback
wearable smartshoe with capability to deliver haptic/vibration feedback to assess effect on freezing of gait
Parkinson's disease without freezing episodes
Participants perform 3 walking tasks in random order: 1 with receiving vibrotactile feedback in swing-phase of gait, 1 with receiving vibrotactile feedback in metronome (regularly timed) vibration (set at low/medium/fast based on preferred/natural walking speed of the patient at baseline), and another with no vibration.
Smartshoes with haptic vibration feedback
wearable smartshoe with capability to deliver haptic/vibration feedback to assess effect on freezing of gait
Healthy Controls
Participants perform 3 walking tasks in random order: 1 with receiving vibrotactile feedback in swing-phase of gait, 1 with receiving vibrotactile feedback in metronome (regularly timed) vibration (set at low/medium/fast based on preferred/natural walking speed of the patient at baseline), and another with no vibration.
Smartshoes with haptic vibration feedback
wearable smartshoe with capability to deliver haptic/vibration feedback to assess effect on freezing of gait
Interventions
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Smartshoes with haptic vibration feedback
wearable smartshoe with capability to deliver haptic/vibration feedback to assess effect on freezing of gait
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
Yes
Sponsors
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Stanford University
OTHER
Responsible Party
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Hengameh Zahed
Clinical Assistant Professor of Neurology
Principal Investigators
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Hengameh Zahed, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Palo Alto, California, United States
Countries
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Other Identifiers
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79809
Identifier Type: -
Identifier Source: org_study_id
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