Can young visual impaired children learn to handle a magnifier?

ISRCTN	ISRCTN84538122
DOI	https://doi.org/10.1186/ISRCTN84538122
Protocol serial number	N/A
Sponsor	Bartiméus (The Netherlands)
Funder	Netherlands Organisation for Health Research and Development (ZonMw), Stichting Oogfonds Nederland

Submission date: 04/04/2006
Registration date: 04/04/2006
Last edited: 08/04/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ralf Cox
Scientific

Bartiméus
P.O. Box 1003
Zeist
3700 BA
Netherlands

Email	r.cox@bartimeus.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Can young visual impaired children learn to handle a magnifier?
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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?
Completion date	01/09/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2.5 Years
Upper age limit	6 Years
Sex	All
Target sample size at registration	47
Total final enrolment	33
Key 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
Key exclusion criteria	1. Developmental delay 2. Impairment of motor skills 3. Prematurity
Date of first enrolment	01/02/2006
Date of final enrolment	01/09/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Bartiméus

Zeist
3700 BA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/06/2009	08/04/2021	Yes	No

Editorial Notes

08/04/2021: Publication reference and total final enrolment added.