Effects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- change in Coma Recovery Scale revised score
研究概览
简要总结
Aim of the study is to define if the auditory stimulation during stepping verticalization sessions with "Erigo" is able to modify the cerebral electric activity or improve consciousness in patients affected by vegetative state or minimally conscious state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vegetative State or Minimally Conscious State diagnosis
- •>3 months from acute brain injury
排除标准
- •No clinical stability
- •Orthopaedic contraindications for verticalization
- •Deep Vein Thrombosis
- •weight >130 Kg
- •height >210 cm
研究组 & 干预措施
Music
Erigo + Music: During each stepping verticalization session the patient receives auditory stimulation (earphones) with previously preferred music
干预措施: Erigo + Music (Other)
Metronome
Erigo + Metronome: During each stepping verticalization session the patient receives auditory stimulation (earphones) with a metronome (rhythmic with the stepping movement)
干预措施: Erigo + Metronome (Other)
Silence
Erigo + Silence: During each stepping verticalization session the patient does note receive any auditory stimulation.
干预措施: Erigo + Silence (Other)
结局指标
主要结局
change in Coma Recovery Scale revised score
时间窗: 0 and 35 days
次要结局
- change in Levels of Cognitive Functioning score(0 and 35 days)
- change in quantitative EEG parameters(0 and 35 days)
- change in Glasgow Coma Scale score(0 and 35 days)
- change in Disability Rating Scale score(0 and 35 days)
研究者
Ilaria Zivi
MD
Ospedale Generale Di Zona Moriggia-Pelascini