Freezing of Gait, Parkinson Disease
Conditions
Keywords
Parkinson Disease, Freezing of gait, Equistasi
Brief summary
Freezing of gait (FOG) is a common disabling condition in Parkinson's disease (PD), causes falls, and impairs quality of life. Therapeutic options for this symptom are limited and of limited efficacy. Besides, the pathophysiology has been not clarified yet. Proprioceptive sensitivity is likely to play a role and recent studies have reported that high-frequency microfocal vibratory stimulation exert a modulatory effect of proprioceptive reflex circuits and could be considered a valuable treatment strategy. However, evidence is not available. The present study was designed to collect preliminary evidence of efficacy of a vibrotactile device (Equistasi) for the treatment of FOG.
Interventions
DEVICEEQUISTASI
Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.
Sponsors
Grisons Foundation for Parkinson's Disease
Fondazione IRCCS Policlinico San Matteo di Pavia
ASST Gaetano Pini-CTO
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient with Parkinson's Disease * Stable drug therapy response without any change in the 3 months before the study. * written informed consent
Exclusion criteria
* Hoehn-Yahr stage ≥ 4 * Cognitive decline (Mini Mental State Examination \<26) * Systemic illness involving the nervous system * Diabetes * Presence of cardiac pacemaker * Presence of deep brain stimulation * Presence of severe dysautonomia with marked hypotension * History or active neoplasia * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freezing of gait questionnaire severity | 4 weeks | Change in freezing of gait questionnaire score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait and Falls Questionnaire (GFQ) score | 4 weeks | Change in the GFQ score |
| 39-item Parkinson's Disease Questionnaire | 4 weeks | Change in quality of life measured using the 39-item Parkinson's Disease Questionnaire |
| Falls | 4 weeks | Number of falls recorded during the intervention period |
| Treatment continuation | 4 weeks | Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale |
Countries
Italy
Outcome results
None listed