Smartshoes for Freezing of Gait in Parkinson's Disease

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07001072
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Smartshoes with haptic vibration feedback — DEVICE
    wearable smartshoe with capability‬ to deliver haptic/vibration feedback to assess effect on freezing of gait

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Participant device tolerance survey score [ Time Frame: immediately after completion of walking tasks on day 1 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305-

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