Effectiveness of Rehabilitation protocol for early management of Craniotomy patients to improve Functional Outcomes in Intensive Care Unit.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 1. Early Functional Ability Scale (EFA)
研究概览
简要总结
BACKGROUND: Craniotomy is a widely used procedure which has several complications in terms of neurological, cardiovascular, psychological, etc. patients who have undergone craniotomy are subjected to physiotherapeutic interventions once these complications arise in patients. As a matter of fact many studies have been done over the management of patients in intensive care units but the evidences for a defined protocol to be followed particularly for craniotomy patients is negligible.
OBJECTIVE: The objective of the study is to test the effects of a rehabilitation protocol for patients undergoing craniotomy from the day of surgery which will prevent complications to occur in such patients enhancing their functional outcomes which in turn improves their quality of life.
METHODOLOGY: It is a single group pre-test post-test experimental design in which patients will be given a pre-set 75 minutes based protocol for preventing the complications after craniotomy. From the day of surgery upto 15th day patients will be administered with protocol being progressive according to the condition of patient. Progression of protocol will depend upon the response of patient to treatment being given and alterations in his/her heath condition. It will be a single blinded study.
RESULTS: Result of study will be checked by certain outcome measures like Early functional ability scale (EFA), Glasgow coma scale, montreal cognitive assessment, coma recovery scale-revised, medical research council scale, modified ashworth scale, sensory modality assessment technique and chest X-rays. The assessment at the baseline prior to commencement of study will be taken and then at completion of 15 day interval.
DISCUSSION: Effect of not only single interventions can be seen but following a rehabilitation protocol will help the patient to functionally overcome probable side-effects of the surgery.
KEY WORDS: Craniotomy, Glasgow coma scale, Intensive Care Unit, Quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients who are ventilated mechanically after the procedure of craniotomy.
- •2.Patients who are on oxygen support, the amount of oxygen being delivered will depend upon the condition of the patient and it’s saturation.
- •Patients who have undergone tracheostomy.
- •4.Patients who have undergone craniotomy for reasons such as: a)Cerebral aneurysm b)Stereotactic aspiration c)Extended bifrontal craniotomy followed by bone flap replacement.
- •d)Minimal invasive supra-orbital craniotomy e)Removal of blood clot from brain vesels.
- •f)Drainage of brain abcess g)Repairing of fractures of the skull.
排除标准
- •1.Patients who have severe fatal infections following the surgery.
- •2.Patients who have an unstable vital such as high blood pressure, irregular tachycardia and bradycardia, low saturation level besides proper mechanical ventilation, exaggerated pulse and heart rate monitoring, etc.
- •3.Patients whose family is not cooperative for the treatment.
- •4.Patients with secondary infections like ventilator-acquired pneumonia.
- •5.Patients who have undergone craniotomy for the following reasons: a)Patients whose brain lobes are removed i.e. lobectomy of the brain segments.
- •b)Patients who were diagnosed with meningioma.
- •c)Patients with malignant skull base tumor.
- •d)Patients who have undergone retro-sigmoid keyhole craniotomy.
- •f)Patients who have undergone orbitozygomatic craniotomy.
- •g)Patients with translabryinthine craniotomy.
- •h)Patients who undergo craniotomy for the process of repair of tear in the duramater.
- •i)Patients with implanted stimulators.
- •6.Patients with hearing and visual loss.
- •7.Patients who are agitated and highly uncooperative post recovery from unconsciousness.
- •Patients of amputation or amputed extremities before the surgical procedure.
结局指标
主要结局
1. Early Functional Ability Scale (EFA)
时间窗: The scale has 4 domains which are further divided into 20 points consisting of 100 scoring marks.It will be take prior to and fter the commencement of the exercsie.
次要结局
- Coma Recovery Scale (CRS)- Revised(it will betaken before and after the intervention i.e. before commencement and after 15 days.)
- Montreal cognitive assessment scale(taken before intervention and after the commencement of 15 days intervention.)
- Modified ashworth scale(it will be taken on the first day and last day of the intervention.)
- Medical research council scale(It will betaken before giving the treatemnt and after the intervention after 15 days.)
- Glasgow Coma Scale (GCS)(It will be taken prior to commencement of the study and after completion of 15 days.)
- Sensory modality assessment technique (SMAT)(It will be taken before and after the 15 days treatment protocol.)
- Chest X-ray(It will be seen before and after treatment intervention of 15 days.)