Parkinson DiseaseNCT07001072
Smartshoes for Freezing of Gait in Parkinson's Disease
A study testing Smartshoes with haptic vibration feedback in people with Parkinson Disease, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Smartshoes with haptic vibration feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mitigating Freezing of Gait (FoG) in Parkinson's Disease With Spatiotemporal Haptic Feedback Delivered by Smartshoes
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
- Being tested
- Smartshoes with haptic vibration feedback
- Keywords
- freezing of gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartshoes with haptic vibration feedbackDevice
Also called NUSHU research
wearable smartshoe with capability to deliver haptic/vibration feedback to assess effect on freezing of gait
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Smartshoes with haptic vibration feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant device tolerance survey score
Measured: immediately after completion of walking tasks on day 1
Total duration of freezing episodes
Measured: Baseline, and day 1 during each walking task (2 min per assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hengameh Zahed, Stanford University
- Investigators
- Hengameh Zahed, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001072
- Sponsor's protocol ID
- 79809
- Status last verified
- May 2026
- First submitted
- 20 May 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Freezing of Gait (FoG) in Parkinson's Disease With Spatiotemporal Haptic Feedback Delivered by Smartshoes
- ClinicalTrials.gov ID
- NCT07001072
- Acronym / sponsor ID
- 79809
- Conditions
- Parkinson Disease
- Keywords
- freezing of gait
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease with freezing episodes | Experimental | Device: Smartshoes with haptic vibration feedbackParticipants 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. |
| Parkinson's disease without freezing episodes | Experimental | Device: Smartshoes with haptic vibration feedbackParticipants 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. |
| Healthy Controls | Experimental | Device: Smartshoes with haptic vibration feedbackParticipants 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- diagnosis of PD according to the UK Brain Bank criteria
- Hoehn and Yahr stages 2 to 3 during the ON phase of PD medication
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartshoes with haptic vibration feedbackAlso: NUSHU researchwearable smartshoe with capability to deliver haptic/vibration feedback to assess effect on freezing of gait | Device | Healthy Controls, Parkinson's disease with freezing episodes, Parkinson's disease without freezing episodes |
Primary outcome
Participant device tolerance survey score
Time frame: immediately after completion of walking tasks on day 1
Total duration of freezing episodes
Time frame: Baseline, and day 1 during each walking task (2 min per assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hengameh Zahed, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartshoes with haptic vibration feedback in people with Parkinson Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant device tolerance survey score (time frame: immediately after completion of walking tasks on day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.