Vibrotactile foot device for improving gait in Parkinson's disease
Vibrotactile Foot Device for Freezing of Gait in Parkinson's Disease
This study tests whether a new vibrating shoe can help people with Parkinson's disease who struggle with freezing of gait feel more stable and move better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06147713 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a newly developed vibrotactile foot device, known as the Smart shoe, on patients with Parkinson's disease who experience freezing of gait (FOG). The trial aims to assess how this non-invasive device can alleviate FOG symptoms, which are common and debilitating in later stages of Parkinson's disease. Participants will undergo EEG and fMRI scans to explore the neurological mechanisms behind the device's effects. The study focuses on individuals who have stable medication regimens and experience frequent episodes of FOG.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30-80 diagnosed with Parkinson's disease who experience freezing of gait more than once per day.
Not a fit: Patients with severe foot sensory impairments or those who have undergone deep brain stimulation surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve mobility and reduce the risk of falls for patients with Parkinson's disease.
How similar studies have performed: While previous studies on vibrotactile stimulation have shown variable results, this approach with a convenient device is relatively novel and lacks extensive clinical trial data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing
- Xuanwu Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Piu Chan, MD. PhD.
- Email: pbchan@hotmail.com
- Phone: +86-010-83198677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.