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

Study Overview
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Brief Summary
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Freezing of gait (FOG) is a common, disabling symptom of later stage Parkinson's disease (PD), and can induce significant morbidity and mortality by increasing risk of falls as the disease progresses. Despite optimum medical management and deep brain stimulation therapy, many patients with PD are incapacitated by FOG and gait disorders. Non-invasive vibrotactile stimulation has been reported to potentially improve FOG of patients with PD. However, results of studies were variable, and there is a lack of convenient vibrotactile devices ready for daily use with reliable clinical trial data. In the proposed study, the investigator will test the effect of a newly developed vibrotactile foot device (Smart shoe) on participants diagnosed with PD and FOG. EEG and fMRI are obtained in order to investigate the underlying neurological mechanism.

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

Conditions
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Parkinson Disease, Freezing of Gait

Intervention / Treatment
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* Device: Vibrotactile foot device (Smart shoe)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Objective presence of FOG by provoking tasks, e.g., gait initiation, rapid full turn, et al. Able to walk unaided at least 20 meters Provide written informed consent Exclusion Criteria: Stroke and other diseases interfering ambulation Severe foot sensory impairments disabling the individual to perceive vibratory stimulation History of deep brain stimulation surgery

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The subjects will be examined for at least 12 hours 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. | Device: Vibrotactile foot device (Smart shoe)<br>* A foot device deliver vibrotactile stimulation triggered by a foot pressure sensor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Freezing of Gait Questionnaire (NFOGQ) | Changes in the New Freezing of Gait Questionnaire (NFOGQ) score | 2 weeks | 
| Freezing severity | Changes in the quantified freezing severity during walking task, videotape reviewed by movement disorder specialists | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Gait parameters | Changes in gait parameters such as stride length, et al. during walking tasks | 2 weeks | 
| MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III | Changes in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score | 2 weeks | 
| Berg Balance Scale | Changes in the Berg Balance Scale score | 2 weeks | 
| Number of falls and near falls | Changes in number of falls and near falls during intervention period | 2 weeks | 
| 39-item Parkinson's Disease Questionnaire (PDQ-39) | Changes in the 39-item Parkinson's Disease Questionnaire (PDQ-39) score | 2 weeks | 
| Clinical Global Impressions Scale (CGI-I) | Changes in the Clinical Global Impressions Scale (CGI-I) score | 2 weeks |