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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201612001886396 |
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Date of registration:
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25/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Assessment and management of visual perceptual problems in children with cerebral palsy in Cross River State, Nigeria
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Scientific title:
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Randomized control trial of the Insight Questions Inventory and tailored visual support strategies versus General support in the management of Perceptual visual disorders/dysfunction in children with cerebral visual palsy. |
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Date of first enrolment:
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02/01/2017 |
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Target sample size:
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370 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1886 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Computer generated Random Sequence using STATA program. Stratified by age; 4-8 and 9-15 and GMFCS Level 1-3 and 4-5.,Allocation was determined by the holder of the sequence who is situated off site
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Phase:
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Phase-3
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Eno
Amponsah |
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Address:
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7 Diamond Hill
Calabar, Cross River State
Nigeria |
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Telephone:
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+234-8023678466 |
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Email:
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giftypee@yahoo.com |
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Affiliation:
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Director Public Relations |
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Name:
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John
Ale Mboto |
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Address:
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Department of Ophthalmology, University of Calabar Teaching Hospital
Calabar, Cross River State
Nigeria |
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Telephone:
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+234-8068054088 |
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Email:
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alemboto@yahoo.com |
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Affiliation:
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Research Coordinator |
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Key inclusion & exclusion criteria
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Inclusion criteria: Children 4-15 years diagnosed with cerebral palsy
Exclusion criteria: Children with other causes of motor disorders and patients who do not want to participate in the study. First degree relative with a family history of CP. Any child who has general developmental regression associated with a developmental disorder.
Age minimum:
4 Year(s)
Age maximum:
15 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cerebral visual impairment, perceptual visual disorder, cerebral palsy
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Cerebral visual impairment, perceptual visual disorder, cerebral palsy
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Intervention(s)
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Insight questions inventory and visual support strategies
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General support treatment open history questions inventory
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Primary Outcome(s)
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A change in quality of life as measured by the difference in mean scores of greater or equal to 0.3sd using the PEDsQL CP 4.0 module 6 weeks after baseline assessment and randomized intervention
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Secondary Outcome(s)
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The effectiveness of closed versus open ended question inventories for detecting symptoms of PVD
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Secondary ID(s)
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CRS/MH/HREC/015/Vol.V/211
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Source(s) of Monetary Support
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Queen Elizabeth Diamond Jubilee Trust, London School of Hygene and Tropical Medicine
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Calabar Childrens Eye Center, University of Calabar Teaching Hospital, Department of Ophthalmology, Cross River State
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Ethics review
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Status: Approved
Approval date: 30/12/2015
Contact:
Cross River Statae Ministry of Health health reasch ethics committee
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Status: Approved
Approval date: 03/10/2016
Contact:
Observational / Interventions Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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