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ISRCTN
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ISRCTN84538122
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ClinicalTrials.gov identifier
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Public title
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Can young visual impaired children learn to handle a magnifier?
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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When young visual impaired children can participate in a training (game) in which a magnifier is used, they learn to handle the magnifier (fine motor skills), they learn to observe small symbols (visual behaviour) and they become interested in the world of small things and know how to visualize these things.
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Lay summary
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Visual impairment
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Participants - inclusion criteria
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1. Children, aged 2.5 to 6 years old, with visual impairment: visual acuity 0.3 or less. All children have normal development
2. Children included will have an ophthalmologic examination, an examination of their gross and fine motor skills, and an examination of their overall level of development
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Participants - exclusion criteria
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1. Developmental delay
2. Impairment of motor skills
3. Prematurity
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Anticipated start date
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01/02/2006
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Anticipated end date
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01/09/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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47
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Interventions
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The experimental group trains with a magnifier. The control group trains without a magnifier.
The training (game) is the intervention. It is given twice a week (20 minutes) for 6 weeks.
The material consists of eight different patterns, each with four pathways made out of small symbols (LH), somewhat like 'ant trails'. The pathways either go horizontal, vertical or round, and they can cross each other. By following the paths with the magnifier, movements are induced in all directions. The goal of the task is to find the symbol at the end of the pathway corresponding to the symbol at the start. The size of the symbols is adjusted to each individual child's visual acuity.
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Primary outcome measure(s)
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1. Can the training teach children to handle a magnifier?
2. Can we find a difference in performance after the training (in motor skills, symbol discrimination, visual behaviour)?
Preliminary analysis (updated 15/11/2006):
Preliminary analysis revealed that the 12-session training had a positive influence on children’s performance on the task. The number of correctly found end-points, attained by adequately following the corresponding path, increased for both training groups. There was however a difference in the amount of increase between the two groups.
On average, the group that has trained without the magnifier performed twice as good. That is, in the post-test they found twice as much correct end-point figures as compared to the pre-test. In the group that has trained with the magnifier, this number was four times as high. Now we are studying the rich data we collected to uncover the relevant variables that determine children’s progression and the differences between the groups. In addition we are looking for a possible transfer of this progression to other domains of their development (e.g., fine-motor skills).
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Secondary outcome measure(s)
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1. How do young visual-impaired children work with a visual aid?
2. Can they perform the complex task of training and magnifier, and do they have a dominant hand and dominant eye?
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Sources of funding
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Netherlands Organisation for Health Research and Development (ZonMw), Stichting Oogfonds Nederland
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Trial website
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Publications
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Contact name
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Dr
Ralf
Cox
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Address
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Bartiméus
P.O. Box 1003
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City/town
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Zeist
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Zip/Postcode
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3700 BA
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Country
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Netherlands
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Email
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r.cox@bartimeus.nl
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Sponsor
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Bartiméus (The Netherlands)
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Address
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P.O. Box 1003
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City/town
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Zeist
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Zip/Postcode
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3700 BA
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Country
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Netherlands
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Date applied
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04/04/2006
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Last edited
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19/12/2007
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Date ISRCTN assigned
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04/04/2006
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