Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria

Sponsor
Makerere University (Other)
Overall Status
Completed
CT.gov ID
NCT00658450
Collaborator
Karolinska Institutet (Other)
123
1
2
32
3.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive rehabilitation training
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
123 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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.
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Oct 1, 2010
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in attention scores [6 months]

    Secondary Outcome Measures

    1. Improvement in memory, reasoning, planning, behaviour and academic achievement [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mulago hospital Acute Care Unit and the Cerebral Malaria Project Kampala Uganda 7051

    Sponsors and Collaborators

    • Makerere University
    • Karolinska Institutet

    Investigators

    • Study Chair: Charles Ibingira, MMED, Chairman, Makerere University Faculty of Medicine Research and Ethics Committee

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Paul Bangirana, Dr Paul Bangirana, Makerere University
    ClinicalTrials.gov Identifier:
    NCT00658450
    Other Study ID Numbers:
    • 2006/HD11/4748U
    First Posted:
    Apr 15, 2008
    Last Update Posted:
    Dec 6, 2012
    Last Verified:
    Dec 1, 2012
    Keywords provided by Paul Bangirana, Dr Paul Bangirana, Makerere University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 6, 2012