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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06147713
• Other study ID #: Vibrotactile Foot Device
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: August 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Piu Chan, MD. PhD.
• Phone: +86-010-83198677
• Email: pbchan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Freezing of Gait
• Parkinson Disease

Intervention

Device:
• Vibrotactile foot device (Smart shoe)
A foot device deliver vibrotactile stimulation triggered by a foot pressure sensor.

Locations

Country	Name	City	State
China	Xuanwu Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New Freezing of Gait Questionnaire (NFOGQ)	Changes in the New Freezing of Gait Questionnaire (NFOGQ) score	2 weeks
Primary	Freezing severity	Changes in the quantified freezing severity during walking task, videotape reviewed by movement disorder specialists	2 weeks
Secondary	Quantitative Gait parameters	Changes in gait parameters such as stride length, et al. during walking tasks	2 weeks
Secondary	MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III	Changes in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score	2 weeks
Secondary	Berg Balance Scale	Changes in the Berg Balance Scale score	2 weeks
Secondary	Number of falls and near falls	Changes in number of falls and near falls during intervention period	2 weeks
Secondary	39-item Parkinson's Disease Questionnaire (PDQ-39)	Changes in the 39-item Parkinson's Disease Questionnaire (PDQ-39) score	2 weeks
Secondary	Clinical Global Impressions Scale (CGI-I)	Changes in the Clinical Global Impressions Scale (CGI-I) score	2 weeks