Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria
The purpose of this study is to determine whether computerised cognitive rehabilitation training improves cognition in children who have had cerebral malaria.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised Trial to Investigate the Effect of a Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria.|
- Improvement in attention scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Improvement in memory, reasoning, planning, behaviour and academic achievement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: 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.
Behavioral: Cognitive rehabilitation training
A computerised cognitive training package where children will be required to complete several cognitive tasks. The aim is to strengthen the different cognitive processes during these tasks which in turn may lead to improve cognitive processes.
Children will complete these tasks in 16 session for 8 weeks.
Other Name: Intervention group
No Intervention: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658450
|Mulago hospital Acute Care Unit and the Cerebral Malaria Project|
|Kampala, Uganda, 7051|
|Study Chair:||Charles Ibingira, MMED||Chairman, Makerere University Faculty of Medicine Research and Ethics Committee|