Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease: a Open, Single-arm Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Freezing of gait questionnaire severity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Parkinson's Disease
- •Stable drug therapy response without any change in the 3 months before the study.
- •written informed consent
排除标准
- •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
研究组 & 干预措施
EQUISTASI
Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.
干预措施: EQUISTASI (Device)
结局指标
主要结局
Freezing of gait questionnaire severity
时间窗: 4 weeks
Change in freezing of gait questionnaire score
次要结局
- Gait and Falls Questionnaire (GFQ) score(4 weeks)
- 39-item Parkinson's Disease Questionnaire(4 weeks)
- Treatment continuation(4 weeks)
- Falls(4 weeks)
研究者
Gianni Pezzoli
Principal Investigator
ASST Gaetano Pini-CTO