Randomized Crossover Study of Pulse Pressure on Respectively Tilt Table With Integrated Stepping Function (Erigo®) and Traditional Tilt Table in Adult Patients With Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in Non Invasive Blood Pressure(NIBP)
研究概览
简要总结
The purpose of this study is to determine if the pulse pressure changes are different whether patients are training in a traditional tilt table as compared to a robotic assisted tilt table, which induces leg movement.
详细描述
The trial takes place in a non private hospital in Denmark. Patients are recruited from two wards treating patients with severe brain injury, and all patients admitted in the study period are considered in regards to inclusion or exclusion. Patients are included via closest relatives accept, and the patients GP(General Practitioner). Any adverse effect or event will be reported to the local ethics committee. All data will be collected simultaneously with the interventions. Some data will be directly recorded via monitor output, and some data will be directly inputted in Epidata, while trial takes place.
Sample size has been calculated to be between 10 and 60 individuals depending on the actual difference. Beyond 60 included individuals the clinical relevance of a statistical significant result is no longer apparent. If any individual variables are noncomplete, an analysis of the subjects with missing data, will be undertaken.
The statistical analyses planned follows the general crossover design using an approach considering 2 treatment and 2 periods. Patients are cluster randomized in clusters of 4, to be treated with one or the other intervention first.
Intervention A:
Traditional tilt table. measurements at 0 degrees 30 deg. 60. deg. and at return to 0 deg.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Already being treated with traditional tilttable and must be able to benefit from Erigo® treatment from a clinicians view
- •Acquired brain injury as primary diagnose
- •Must have Rancho Los Amigo Scale score of minimum 1 to maximum 6 on the day of inclusion
排除标准
- •Not on mechanical ventilation
- •New cerebral, cardiological or other medical problems/emergencies between the 2 interventions
- •Change in cardiac medications between interventions
- •Patient must not have independent gait function immediately before trial
- •must not have EFA(Early Functional abilities) part score > 4 in the section "Standing", assessed by the treating physiotherapist.
结局指标
主要结局
Change in Non Invasive Blood Pressure(NIBP)
时间窗: Measured at: Baseline in supine on tilttable, 60 seconds after 30 degrees rise of tilttable, 60 seconds after 60 degrees tilt is reached. Again 60 seconds after return to 0 degrees tilt with patient still in supine position on tilttable..
次要结局
- Patient reported comfort: The difference in prevalence of both acceptable- and not acceptable patient comfort between the Erigo and the conventional tilt-table.(Question is asked within 5 minutes after 60 degrees NIBP measurement)