Vibrotactile Foot Device for Freezing of Gait in Parkinson's Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention 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)
A foot device deliver vibrotactile stimulation triggered by a foot pressure sensor.
|
Outcome Measures
Primary Outcome Measures
- New Freezing of Gait Questionnaire (NFOGQ) [2 weeks]
Changes in the New Freezing of Gait Questionnaire (NFOGQ) score
- Freezing severity [2 weeks]
Changes in the quantified freezing severity during walking task, videotape reviewed by movement disorder specialists
Secondary Outcome Measures
- Quantitative Gait parameters [2 weeks]
Changes in gait parameters such as stride length, et al. during walking tasks
- MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III [2 weeks]
Changes in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score
- Berg Balance Scale [2 weeks]
Changes in the Berg Balance Scale score
- Number of falls and near falls [2 weeks]
Changes in number of falls and near falls during intervention period
- 39-item Parkinson's Disease Questionnaire (PDQ-39) [2 weeks]
Changes in the 39-item Parkinson's Disease Questionnaire (PDQ-39) score
- Clinical Global Impressions Scale (CGI-I) [2 weeks]
Changes in the Clinical Global Impressions Scale (CGI-I) score
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 30-80 years
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Diagnosed with Parkinson's Disease according to MDS Clinical Diagnostic Criteria
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Stable drug therapy without any change in the past one month
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Subjective presence of FOG more than once per day
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Objective presence of FOG by provoking tasks, e.g., gait initiation, rapid full turn, et al.
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Able to walk unaided at least 20 meters
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Provide written informed consent
Exclusion Criteria:
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Stroke and other diseases interfering ambulation
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Severe foot sensory impairments disabling the individual to perceive vibratory stimulation
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History of deep brain stimulation surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xuanwu Hospital | Beijing | China |
Sponsors and Collaborators
- Xuanwu Hospital, Beijing
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Vibrotactile Foot Device