Vibrotactile Foot Device for Freezing of Gait in Parkinson's Disease
Vibrotactile foot device (Smart shoe)
Synucleinopathies+6
+ Basal Ganglia Diseases
+ Brain Diseases
Treatment Study
Summary
Study start date: May 1, 2022
Actual date on which the first participant was enrolled.This study focuses on helping people with Parkinson's Disease who experience a symptom called "freezing of gait" (FOG). FOG can be very challenging as it makes walking difficult and increases the risk of falls, especially in the later stages of Parkinson's. Existing treatments like medication and deep brain stimulation don't always work for everyone. This study aims to test a new device called a "Smart shoe," which uses gentle vibrations to possibly improve walking ability in those affected by FOG. The goal is to determine if this non-invasive approach can be a practical, everyday aid for those struggling with this aspect of Parkinson's. Participants in the study will wear the Smart shoe, which is designed to provide vibrotactile stimulation to the foot. While using the device, researchers will monitor brain activity using EEG and fMRI scans to understand how the brain responds to this treatment. This will help determine if and how the device helps alleviate FOG symptoms. The study aims to provide insights into the effectiveness of the device, with the hope of improving mobility and reducing falls in people with Parkinson's.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 30 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location