Suspended

Vibrotactile Foot Device for Freezing of Gait in Parkinson's Disease

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What is being tested

Vibrotactile foot device (Smart shoe)

Device
Who is being recruted

Synucleinopathies+6

+ Basal Ganglia Diseases

+ Brain Diseases

From 30 to 80 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2022
See protocol details

Summary

Principal SponsorXuanwu Hospital, Beijing
Study ContactPiu Chan, MD. PhD.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2022

Actual date on which the first participant was enrolled.

This study focuses on helping people with Parkinson's Disease who experience a symptom called "freezing of gait" (FOG). FOG can be very challenging as it makes walking difficult and increases the risk of falls, especially in the later stages of Parkinson's. Existing treatments like medication and deep brain stimulation don't always work for everyone. This study aims to test a new device called a "Smart shoe," which uses gentle vibrations to possibly improve walking ability in those affected by FOG. The goal is to determine if this non-invasive approach can be a practical, everyday aid for those struggling with this aspect of Parkinson's. Participants in the study will wear the Smart shoe, which is designed to provide vibrotactile stimulation to the foot. While using the device, researchers will monitor brain activity using EEG and fMRI scans to understand how the brain responds to this treatment. This will help determine if and how the device helps alleviate FOG symptoms. The study aims to provide insights into the effectiveness of the device, with the hope of improving mobility and reducing falls in people with Parkinson's.

Official TitleVibrotactile Foot Device for Freezing of Gait in Parkinson's Disease
NCT06147713
Principal SponsorXuanwu Hospital, Beijing
Study ContactPiu Chan, MD. PhD.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesParkinson DiseaseNeurodegenerative DiseasesParkinsonian Disorders

Criteria

7 inclusion criteria required to participate
Age 30-80 years

Diagnosed with Parkinson's Disease according to MDS Clinical Diagnostic Criteria

Stable drug therapy without any change in the past one month

Subjective presence of FOG more than once per day

Show More Criteria

3 exclusion criteria prevent from participating
Stroke and other diseases interfering ambulation

Severe foot sensory impairments disabling the individual to perceive vibratory stimulation

History of deep brain stimulation surgery

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The subjects will be examined during the drug-off period with the vibrotactile foot device off and on at different patterns. The tests will be carried out during the onsite clinical visits on the day of initial enrollment and two weeks after home wearing.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Xuanwu Hospital

Beijing, ChinaOpen Xuanwu Hospital in Google Maps
SuspendedOne Study Center