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临床试验/CTRI/2023/11/060074
CTRI/2023/11/060074尚未招募2 期

Caregiver-mediated Vellore intense Multimodal Sensory Stimulation (Vi-MuSt) for improving the level of consciousness in patients with severe brain injury: A Single-blind, Randomized Controlled Trial

Christian Medical College Vellore1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年12月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
22
试验地点
1
主要终点
JFK Coma recovery scale- Revised (CRS-R), Wessex Head Injury Matrix (WHIM)

研究概览

简要总结

Multi-modal sensory stimulation is considered as a treatment method to reduce the risk of sensory deprivation and facilitate brain recovery responses in patients with a decreased level of consciousness following brain injury. Multi-modal sensory stimulation programs in the early stages after brain injury can be very useful for the recovery process. Involving the family members in sensory stimulation, besides providing them with the opportunity to get engaged in patient care, accelerates the improvement of patients’ level of consciousness, cognitive status, and recovery. Caregiver-mediated Multi-modal sensory stimulation will be beneficial for the patients with severe brain injury because they spend the most of their time in a day with patients’.

The caregivers of persons with brain injury in the Vi-MuSt group will be educated and trained by the Occupational, Physical and Speech Therapists on how to carry out the stimulation program during the therapy and at their rooms. Each stimulation session can last from 20 to 30 minutes for five times a day between 6 am to 9 pm and 6 days a week. The usual care group will receive regular intervention provided by the therapists during the therapy hours along with the involvement of caregivers. The primary outcome measures used will be JFK Coma recovery scale- Revised (CRS-R) and Wessex Head Injury Matrix (WHIM) and Secondary Outcome measure used will be Disability Rating Scale (DRS). Pre-assessment will be done in the first week after the allocation to the group and Post assessment after 4 weeks following the pre-assessment in both the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with brain injury who are in Coma, Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS), RLA stage I to III (No response, generalized response and localized response).

排除标准

  • Patients with complications such as recurrent seizures, unstable vital signs will be excluded.

结局指标

主要结局

JFK Coma recovery scale- Revised (CRS-R), Wessex Head Injury Matrix (WHIM)

时间窗: Pre-assessment will be done in the first week after the allocation to the group and Post assessment after 4 weeks following the pre-assessment in both the groups.

次要结局

  • Disability Rating Scale (DRS)(Pre-assessment will be done in the first week after the allocation to the group and Post assessment after 4 weeks following the pre-assessment in both the groups.)

研究者

发起方
Christian Medical College Vellore
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Jones Jeromedanypraveenraj

Christian Medical College, Vellore

研究点 (1)

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