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

NCT06147713 | Unknown DMC

• 1 other identifier: Vibrotactile Foot Device
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Freezing of Gait

Outcome Measures

Primary Outcomes (2)

• New Freezing of Gait Questionnaire (NFOGQ)

  Changes in the New Freezing of Gait Questionnaire (NFOGQ) score

  2 weeks

• Freezing severity

  Changes in the quantified freezing severity during walking task, videotape reviewed by movement disorder specialists

  2 weeks

Secondary Outcomes (6)

• Quantitative Gait parameters

  2 weeks

• MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III

  2 weeks

• Berg Balance Scale

  2 weeks

• Number of falls and near falls

  2 weeks

• 39-item Parkinson's Disease Questionnaire (PDQ-39)

  2 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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)

Interventions

Vibrotactile foot device (Smart shoe) DEVICE

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

Intervention

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Stroke and other diseases interfering ambulation
• Severe foot sensory impairments disabling the individual to perceive vibratory stimulation
• History of deep brain stimulation surgery

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Piu Chan, MD. PhD.

CONTACT

+86-010-83198677; pbchan@hotmail.com

Shanshan Cen, MD. PhD.

CONTACT

censs843@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 28, 2023
• Study Start: May 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2023-08

Locations

CN (1)