Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease: a Open, Single-arm Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Freezing of Gait
- Sponsor
- ASST Gaetano Pini-CTO
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Freezing of gait questionnaire severity
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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.
Investigators
Gianni Pezzoli
Principal Investigator
ASST Gaetano Pini-CTO
Eligibility Criteria
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
- •Presence of cardiac pacemaker
- •Presence of deep brain stimulation
- •Presence of severe dysautonomia with marked hypotension
- •History or active neoplasia
- •Pregnancy
Outcomes
Primary Outcomes
Freezing of gait questionnaire severity
Time Frame: 4 weeks
Change in freezing of gait questionnaire score
Secondary Outcomes
- Gait and Falls Questionnaire (GFQ) score(4 weeks)
- 39-item Parkinson's Disease Questionnaire(4 weeks)
- Treatment continuation(4 weeks)
- Falls(4 weeks)