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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's disease with freezing episodes | Experimental | 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. |
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| Parkinson's disease without freezing episodes | Experimental | 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. |
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| Healthy Controls | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartshoes with haptic vibration feedback | Device | wearable smartshoe with capability‬ to deliver haptic/vibration feedback to assess effect on freezing of gait |
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| Measure | Description | 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) |
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Inclusion Criteria:
For patients with Parkinson disease:
For patients with Parkinson disease withOUT freezing of gait:
For all participants (PD with or without freezing, or age-matched controls):
Exclusion Criteria:
For all participants (PD with or without freezing, or age-matched controls)
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| Name | Affiliation | Role |
|---|---|---|
| Hengameh Zahed, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |