Efficacy of Cognitive Retraining and Compensatory Based Rehabilitation Program in Enhancing Cognitive and Day to Day Functioning of Mild and Complicated Mild Traumatic Brain Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. PGI Battery of Brain Dysfunction for assessing Brain Dysfunction
研究概览
简要总结
This study is a repeated measures design with three time points pre-test, post-test and follow up. The study is investigating the efficacy of cognitive retraining and compensatory strategies program in enhancing cognitive functions and activities of daily living in mild and complicated mild traumatic brain injury patients.
Patients sustaining injury prior to 3 months will be recruited and assessed. Each patient is recruited upon consideration of the inclusion and exclusion criteria of the study. Patient consent will be taken after which the cognitive rehabilitation program will be provided to the patient. The program will be tailored according to each patient and will span up to two and a half months, containing 33 sessions of 2 hours each. Post assessment will take place after the program is completed at 5 to 6 month of the injury after which the follow up will take place at the 7th to 8th month of the injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria: MTBI
- •Brain damage due to external trauma
- •GCS score of 13-15 at the time of arrival
- •Educated 8th class and above
- •Ability to comprehend English or Hindi
- •Time post injury 1- 3 months
- •Cooperation from the patient and caregiver Inclusion criteria: Complicated MTBI
- •Neuroimaging shows intracranial abnormalities
- •Educated 8th class and above
- •Time post injury up to 1- 3 months 8.
排除标准
- •Exclusion criteria: MTBI
- •Neuroimaging shows intracranial abnormalities
- •Severe deficits in motor, visual or hearing abilities
- •Past history of mental illness, i.e. Substance use disorder, Schizophrenia, Anxiety, Depression, and other psychiatric disorders
- •Past history of neurodevelopmental, neurodegenerative or any other neurological disease, i.e. Intellectual disability, Epilepsy, Early onset dementia, Stroke, Brain tumour, Parkinsons disease, Alzheimer disease and Multiple sclerosis etc.
- •Exclusion criteria: Complicated MTBI 1.
结局指标
主要结局
1. PGI Battery of Brain Dysfunction for assessing Brain Dysfunction
时间窗: 1. Pre-test | 2. Post-test | 3. Follow up
2. Cognitive symptoms checklist for assessing Activities of Daily Living
时间窗: 1. Pre-test | 2. Post-test | 3. Follow up
次要结局
- Demographic variables (age, gender, occupation, marital status, education)(1. Pre-test)
- Clinical variables (time post-injury, duration of post-traumatic amnesia (PTA), duration of loss of consciousness (LOC))(1. Pre-test)
研究者
Saishree
Banaras Hindu University