Back to resultsRehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria
Primary Purpose
Malaria, Cerebral
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Cognitive rehabilitation training
Sponsored by
About this trial
This is an interventional treatment trial for Malaria, Cerebral focused on measuring Malaria, Cerebral
Eligibility Criteria
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).
CM group Exclusion Criteria:
- 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.
Sites / Locations
- Mulago hospital Acute Care Unit and the Cerebral Malaria Project
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cognitive rehabilitation training
Treatment as usual
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Improvement in attention scores
Secondary Outcome Measures
Improvement in memory, reasoning, planning, behaviour and academic achievement
Full Information
NCT ID
NCT00658450
First Posted
April 10, 2008
Last Updated
December 5, 2012
Sponsor
Makerere University
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT00658450
Brief Title
Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria
Official Title
A Randomised Trial to Investigate the Effect of a Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makerere University
Collaborators
Karolinska Institutet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether computerised cognitive rehabilitation training improves cognition in children who have had cerebral malaria.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Cerebral
Keywords
Malaria, Cerebral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive rehabilitation training
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive rehabilitation training
Other Intervention Name(s)
Intervention group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in attention scores
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement in memory, reasoning, planning, behaviour and academic achievement
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
CM group Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Ibingira, MMED
Organizational Affiliation
Chairman, Makerere University Faculty of Medicine Research and Ethics Committee
Official's Role
Study Chair
Facility Information:
Facility Name
Mulago hospital Acute Care Unit and the Cerebral Malaria Project
City
Kampala
ZIP/Postal Code
7051
Country
Uganda
12. IPD Sharing Statement
Citations:
PubMed Identifier
16930255
Citation
Bangirana P, Idro R, John CC, Boivin MJ. Rehabilitation for cognitive impairments after cerebral malaria in African children: strategies and limitations. Trop Med Int Health. 2006 Sep;11(9):1341-9. doi: 10.1111/j.1365-3156.2006.01685.x.
Results Reference
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PubMed Identifier
17224457
Citation
Boivin MJ, Bangirana P, Byarugaba J, Opoka RO, Idro R, Jurek AM, John CC. Cognitive impairment after cerebral malaria in children: a prospective study. Pediatrics. 2007 Feb;119(2):e360-6. doi: 10.1542/peds.2006-2027. Epub 2007 Jan 15.
Results Reference
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Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria
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