A Randomised Trial to Investigate the Effect of a Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Improvement in attention scores
研究概览
简要总结
The purpose of this study is to determine whether computerised cognitive rehabilitation training improves cognition in children who have had cerebral malaria.
详细描述
Cerebral malaria affects several children in sub-Saharan Africa leaving some survivors with cognitive problems especially in attention and memory. There are currently no tested interventions for such deficits resulting from infectious diseases like malaria or other causes. Providing such interventions will go a long way in helping these children achieve their full potential.
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
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CM group Inclusion Criteria:
- •aged five to 15 years, presenting with asexual forms of P. falciparum malaria on a peripheral blood smear, unarousable coma (not able to localize a painful stimulus) and no other cause for coma (normal CSF).
排除标准
- •history of or present meningitis, encephalitis, prior CM, sickle cell disease (SCD), HIV infection, epilepsy, multiple seizures, developmental delay and history of hospitalization for malnutrition.
- •Healthy control group Inclusion Criteria:
- •aged five to 15 years with no other illness at present, within two years of the CM child (for CM children aged 5 and 6 years, the HC's age wont go below 5 and for CM children aged 14 and 15, the HC's age wont go above 15 years).
- •Healthy control group Exclusion Criteria:
- •history of or present bacterial meningitis, encephalitis, CM, SCD, HIV infection, history of hospitalization for malnutrition and any chronic illness for which the patient is currently taking medication.
研究组 & 干预措施
Cognitive rehabilitation training
Children in this arm will the receive the intervention comprising of 16 cognitive rehabilitation training (CRT) exercises for 8 weeks. These exercises will train different cognitive skills including attention, visual spatial processing, logical skills and memory.
干预措施: Cognitive rehabilitation training (Behavioral)
Treatment as usual
Children in this group will not receive any intervention, they will undergo the usual post discharge treatment for brain injured children at Mulago Hospital (the study site). This is the treatment as usual (TAU) group.
结局指标
主要结局
Improvement in attention scores
时间窗: 6 months
次要结局
- Improvement in memory, reasoning, planning, behaviour and academic achievement(6 months)
研究者
Paul Bangirana
Dr Paul Bangirana
Makerere University