A Randomised Control Trial to Determine the Effectiveness of Sensory Stimulation Program in Reducing the Length of Time Spent by Severely Brain Injured Patients in a Vegetative State in the Acute Hospital Environment
试验速览
- 阶段
- 4 期
- 发起方
- 试验地点
- 4
- 主要终点
- Patients are allocated to a level on the SMART scale every ten days, compariosns are made between the control and experimental groups
研究概览
简要总结
A randomised control trial of patients who have a severe brain injury to determine if patients who receive a standardised sensory stimulation program emerge earlier from a vegetative state. The experimental group would receive, in addition to their normal occuaptional therapy, sensory stimulation which would involve the daily application of stimulation to all five senses using the Sensory Modalities Assessment and Rehabilitation Technique (SMART).
详细描述
A randomised control trial of patients who have a severe brain injury to determine if patients who receive a standardised sensory stimulation program emerge earlier from a vegetative state. The experimental group would receive, in addition to their normal occupational therapy, sensory stimulation which would involve the daily application of stimulation to all five senses using the Sensory Modalities Assessment and Rehabilitation Technique (SMART).
The SMART is both an assessment and treatment too. Patients in both groups will have baseline assessments conducted using the SMART, with further assessments conducted every ten days for thrity days. The SMART is designed to provide quantitative data in the assessment of the patients cognitive function and potential awareness. It is a five point hierarchical scale from level 1 ( no response) to level 5 (discriminating).
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
- Single
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admitted with severe brain injury
- •GCS of 9 or less. A GCS score of 9 or less is indicative of a severe brain injury
- •medically stable, as documented by medical staff
- •age 18 to 65 years
- •controlled intracranial pressure no sedation
- •no previous brain injury
排除标准
- •patient declared brain dead
- •next of kin withdraws patient from the study
- •withdrawal of consent by patient on waking
- •raised uncontrolled intracranial pressure, following discussions with treating medical team
- •patient enrolled in DECRA or RSI Trials
结局指标
主要结局
Patients are allocated to a level on the SMART scale every ten days, compariosns are made between the control and experimental groups
次要结局
- Fucntional status at six months, assessed using the modified Barthel