Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 9
- 主要终点
- Changes in Spatio-Temporal gait variables at 20 weeks
研究概览
简要总结
It's already known the efficacy of Gait Analysis (GA) on evaluating gait modification on Parkinson's Disease (PD) Patients (1). On the other hand Proprioceptive Focal Stimulation seems be useful in symptoms amelioration in several neurological disease. Few studies have been performed in Parkinson's disease. A total of 126 patients suffering from PD will be recruited in 6 italian neurological centers. The study will be a cross-over multicenter study with the randomization of the sequence. The patients will be randomly assigned to 2 groups receiving for 8 weeks either the Equistasi medical device, or an equivalent placebo. Gait analysis will be recorded in each patient at the beginning and at the end of the treatment assigned. After 4 weeks of wash-out, the treatment will be crossed and a new gait analysis recording will be performed. Finally a last recording will be taken at the end of the last 8 weeks. Secondary outcome will be the MDS-UPDRS (Movement Disorder Society - Unified Parkinson Disease Rating Scale), PDQ-39 (Parkinson Disease 39 Questionnaire ), ABC (Activity Specific Balance Confidence Scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with rigid-acinetic bilateral PD form
- •At least 4 years of disease history
- •H&Y between 2-3
- •Stable drug therapy response without any change performed in the 3 months before the study.
- •Presence of freezing (FOG) and of postural instability not responding to parkinsonian therapy.
- •MMSE>24/30 (Mini-Mental State Examination)
排除标准
- •Systemic illness
- •Presence of cardiac pacemaker
- •Presence of deep brain stimulation
- •Presence of severe dysautonomia with marked hypotension
- •Obsessive-Compulsive disorder (OCD)
- •Major depression
- •History or active neoplasia
- •Pregnancy
结局指标
主要结局
Changes in Spatio-Temporal gait variables at 20 weeks
时间窗: 20 weeks
次要结局
- Changes in the Parkinson Disease 39 Questionnaire (PDQ-39) at 20 weeks(20 weeks)
- Changes in the Activity Specific Balance Confidence Scale (ABC scale) at 20 weeks(20 weeks)
- Changes in the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) - at 20 weeks(20 weeks)
研究者
Antonella Peppe
MD, PhD
I.R.C.C.S. Fondazione Santa Lucia