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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibrotactile foot device (Smart shoe) | Device | A foot device deliver vibrotactile stimulation triggered by a foot pressure sensor. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piu Chan, MD. PhD. | Contact | +86-010-83198677 | pbchan@hotmail.com | |
| Shanshan Cen, MD. PhD. | Contact | censs843@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |