Smartshoes for Freezing of Gait in Parkinson's Disease

Stanford University

Status: Not yet enrolling

Conditions: Parkinson Disease

Treatments: Device: Smartshoes with haptic vibration feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT07001072

79809

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 3 patient groups

Parkinson's disease with freezing episodes

Experimental group

Description:

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.

Treatment:

Device: Smartshoes with haptic vibration feedback

Parkinson's disease without freezing episodes

Experimental group

Description:

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.

Treatment:

Device: Smartshoes with haptic vibration feedback

Healthy Controls

Experimental group

Description:

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.

Treatment:

Device: Smartshoes with haptic vibration feedback