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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
A foot device deliver vibrotactile stimulation triggered by a foot pressure sensor.
Xuanwu Hospital
Beijing, China
RECRUITINGNew Freezing of Gait Questionnaire (NFOGQ)
Changes in the New Freezing of Gait Questionnaire (NFOGQ) score
Time frame: 2 weeks
Freezing severity
Changes in the quantified freezing severity during walking task, videotape reviewed by movement disorder specialists
Time frame: 2 weeks
Quantitative Gait parameters
Changes in gait parameters such as stride length, et al. during walking tasks
Time frame: 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
Time frame: 2 weeks
Berg Balance Scale
Changes in the Berg Balance Scale score
Time frame: 2 weeks
Number of falls and near falls
Changes in number of falls and near falls during intervention period
Time frame: 2 weeks
39-item Parkinson's Disease Questionnaire (PDQ-39)
Changes in the 39-item Parkinson's Disease Questionnaire (PDQ-39) score
Time frame: 2 weeks
Clinical Global Impressions Scale (CGI-I)
Changes in the Clinical Global Impressions Scale (CGI-I) score
Time frame: 2 weeks
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