Smartshoes for Freezing of Gait in Parkinson's Disease

NCT07001072 | Not Yet Recruiting FDA Device

• 1 other identifier: 79809
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

freezing of gait

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (3)

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.

Device: Smartshoes with haptic vibration feedback

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.

Device: Smartshoes with haptic vibration feedback

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.

Device: Smartshoes with haptic vibration feedback

Interventions

Smartshoes with haptic vibration feedback DEVICE

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

Also known as: NUSHU research

Healthy Controls; Parkinson's disease with freezing episodes; Parkinson's disease without freezing episodes

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Hengameh Zahed, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Neurology

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 3, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)