Contact information
Type
Scientific
Primary contact
Dr Ralf Cox
ORCID ID
Contact details
Bartiméus
P.O. Box 1003
Zeist
3700 BA
Netherlands
r.cox@bartimeus.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Visual impairment
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 childrens 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 childrens 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).
Secondary outcome measures
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?
Overall trial start date
01/02/2006
Overall trial end date
01/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
47
Participant exclusion criteria
1. Developmental delay
2. Impairment of motor skills
3. Prematurity
Recruitment start date
01/02/2006
Recruitment end date
01/09/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Bartiméus
Zeist
3700 BA
Netherlands
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw), Stichting Oogfonds Nederland
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary