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

NCT ID: NCT06147713

Last Updated: 2024-02-02

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-11-01

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.

Detailed Description

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Conditions

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Parkinson Disease Freezing of Gait

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Vibrotactile foot device (Smart shoe)

Intervention Type DEVICE

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.

Intervention Type DEVICE

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuanwu Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Piu Chan, MD. PhD.

Role: CONTACT

+86-010-83198677

Shanshan Cen, MD. PhD.

Role: CONTACT

Facility Contacts

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Piu Chan, MD.,PhD.

Role: primary

+86-010-83198677

Other Identifiers

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Vibrotactile Foot Device

Identifier Type: -

Identifier Source: org_study_id

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