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

Not Applicable

Recruiting

• Conditions: Freezing of Gait; Parkinson Disease

• Registration Number: NCT06147713
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2023-08
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-28
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-02
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xuanwu Hospital; 🇨🇳 Beijing, China