Vibrotactile Foot Device for Freezing of Gait in Parkinson's Disease
NCT ID: NCT06147713
Last Updated: 2024-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2022-05-01
2024-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
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.
Vibrotactile foot device (Smart shoe)
A foot device deliver vibrotactile stimulation triggered by a foot pressure sensor.
Interventions
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Vibrotactile foot device (Smart shoe)
A foot device deliver vibrotactile stimulation triggered by a foot pressure sensor.
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe foot sensory impairments disabling the individual to perceive vibratory stimulation
* History of deep brain stimulation surgery
30 Years
80 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Locations
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Xuanwu Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Vibrotactile Foot Device
Identifier Type: -
Identifier Source: org_study_id
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