Early rehabilitation for children with visual processing dysfunctions from 1 year of age: a Randomized Controlled Trial protocol

Background An increasing amount of children suffer from brain damage-related visual processing dysfunctions (VPD). At present, there is a lack of evidence-based rehabilitation methods that can be used early in development. We developed a visual rehabilitation protocol suitable from 1 year of age. The protocol contains objective, quantitative outcomes and is structured, comprehensive and individually-adaptive. Our aim is to investigate effectiveness of this first visual rehabilitation program for young children with (a risk of) VPD. Methods We conduct a single-blind, placebo-controlled trial that is embedded within standard clinical care. The study population consists of 100 children born very or extremely preterm (<30 weeks) of 1 year of corrected age (CA), of whom 50% are expected to have VPD. First, children undergo a visual screening at 1 year CA. If they are classified as being at risk of VPD, they are referred to standard care: an ophthalmic and visual function assessment and a (newly developed) visual rehabilitation program. This program consist of a general protocol (standardized and similar for all children) and a supplement protocol (adapted to specific needs of the child), and employs quantitative parameters of visual outcome. Children are randomly allocated to an intervention group (starting upon inclusion at 1 year CA), or a control group (postponed: starting at 2 years CA). The control group will receive a placebo treatment. The effectiveness of early visual rehabilitation will be examined with follow-up visual and neurocognitive assessments after 1 year (upon completion of the direct intervention) and after 2 years (upon completion of the postponed intervention). Discussion Through this RCT we will establish the effectiveness of a new and early visual rehabilitation program. Combining a general and supplement protocol enables structured comparisons between participants and groups, and custom rehabilitation that is tailored to the children’s specific needs. The design ensures that all included children will benefit from participation by advancing the age at which they start receiving rehabilitation. We expect results to be applicable to all children with (a risk of) VPD early in life.