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

NCT06147713 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-02-02

No results posted yet for this study

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.

Conditions

  • Parkinson Disease
  • Freezing of Gait

Interventions

DEVICE

Vibrotactile foot device (Smart shoe)

A foot device deliver vibrotactile stimulation triggered by a foot pressure sensor.

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-11-01
Completion
2024-11-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06147713 on ClinicalTrials.gov