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

January 31, 2024 updated by: Xuanwu Hospital, Beijing
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Xuanwu Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Vibrotactile foot device (Smart shoe)
A foot device deliver vibrotactile stimulation triggered by a foot pressure sensor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New Freezing of Gait Questionnaire (NFOGQ)
Time Frame: 2 weeks
Changes in the New Freezing of Gait Questionnaire (NFOGQ) score
2 weeks
Freezing severity
Time Frame: 2 weeks
Changes in the quantified freezing severity during walking task, videotape reviewed by movement disorder specialists
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Gait parameters
Time Frame: 2 weeks
Changes in gait parameters such as stride length, et al. during walking tasks
2 weeks
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
Time Frame: 2 weeks
Changes in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score
2 weeks
Berg Balance Scale
Time Frame: 2 weeks
Changes in the Berg Balance Scale score
2 weeks
Number of falls and near falls
Time Frame: 2 weeks
Changes in number of falls and near falls during intervention period
2 weeks
39-item Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: 2 weeks
Changes in the 39-item Parkinson's Disease Questionnaire (PDQ-39) score
2 weeks
Clinical Global Impressions Scale (CGI-I)
Time Frame: 2 weeks
Changes in the Clinical Global Impressions Scale (CGI-I) score
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vibrotactile Foot Device

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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