Safety, Feasibility and Efficacy of Subject Specific Integrated Multi-Sensory Stimulation ProgramFor Patients with Severe Traumatic Brain Injury in Acute setup
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Coma recovery scale- revised
研究概览
简要总结
Patients will be screened depending upon the inclusion criteria. Informed consent to participate in the study shall be taken from the guardian of the patients. Provision for re-consent will be made once the patient is cognitively capable. The patients will be allocated to 2 groups ie) control group and experimental group. A block randomization method will be used for allocation.
Control group will be administered with the conventional coma arousal technique that uses various stimuli viz.) music for auditory stimulation, photos for visual stimulation, touch for tactile stimulation, familiar smell as olfactory stimulation, etc. single stimuli or a combination of them will be used.
The experimental group will be administered with the newly developed therapy –“subject-specific integrated multisensory stimulation program†A detailed history about likes and dislikes of the patients will be taken on 3 domains 1) personal, professional and recreational. Depending upon it, a functional task will be made for the patient that includes various stimuli like auditory, tactile, proprioceptive, gustatory, etc. taking into consideration its feasibility Various functional tasks that include all the stimuli or a combination of them will be used for the patient.
The duration of treatment will be the same for both the groups – 45 minutes thrice a day for 14 days. Vitals, GCS, ABS, FOUR, CRS-R, DOCS-25 will be taken at the time of admission, every day as a form of reassessment till the 14th day. Length of stay and GOS-E scores shall be taken at the time of discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Glasgow Coma Scale (GCS) ≤8 for ≥24h from the event -Stable hemodynamic (absence of dangerous variations of Mean Arterial Pressure or Heart Rate -Admitted to the neurosurgical unit -Approval of treating physician.
排除标准
- •History of prior brain injury -Premorbid history of uncorrected visual or hearing impairments -Premorbid history of developmental, psychiatric, or neurologic illness resulting in documented functional disability up to the time of the injury -Coma or persistent vegetative state not caused by TBI -Acute medical illness -Medical complications during the study -Active Otorrhoea or Rhinorrhoea.
结局指标
主要结局
Coma recovery scale- revised
时间窗: Baseline, everyday till day 14
次要结局
- Rancho los amigos scale RLA(baseline,everyday till day 14)
- GCS(Baseline, everyday till day 14)
- Length of stay (in days)(At discharge)
- Agitated behavioral scale(baseline, everyday till day 14)
- Disorders of consciousness scale DOCS-25(Baseline,everyday till day 14)
- Glasgows outcome scale extended (GOS-E)(On discharge/on 14th day)
- The Full Outline of UnResponsiveness (FOUR) score scale(baseline,everyday till 14th day)