Efficacy of "Equistasi" on the Gait of Patients Affected by Hemiparesis Due to Cerebrovascular Accident
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- disability change assessed using Functional Independence Measure scale
研究概览
简要总结
The purpose of the study is to evaluate the effect of "Equistasi" device on quantitative and qualitative gait characteristics in patients affected by hemiparesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subacute hemiparesis
- •Functional Ambulation Classification <4
排除标准
- •previous neurological deficits
- •Glasgow Coma Scale <13
- •Complete sensory deficit in the lower limbs
- •Levels of Cognitive Functioning ≤5
- •polyneuropathy
- •contraindications to mobilization/verticalization
结局指标
主要结局
disability change assessed using Functional Independence Measure scale
时间窗: 0. 30. 60. 120 days
balance change assessed using Berg Balance Scale
时间窗: 0. 30. 60. 120 days
gait pattern change assessed using Functional Ambulation Classification scale
时间窗: 0. 30. 60. 120 days
gait speed change assessed using Timed Up and Go scale
时间窗: 0. 30. 60. 120 days
gait speed change assessed using 10 meter walking test scale
时间窗: 0. 30. 60. 120 days
swaying of the center of gravity change assessed with stabilometric platform indexes
时间窗: 0. 30. 60. 120 days
gait pattern change using Tinetti scale for gait
时间窗: 0. 30. 60. 120 days
次要结局
未报告次要终点
研究者
Ilaria Zivi
MD
Ospedale Generale Di Zona Moriggia-Pelascini