Department of Occupational Therapy, College of Medicine, National Taiwan University
Taipei, Taiwan
Location status: Recruiting
NCT Number: NCT06701617
Restorative visual rehabilitation is frequently used to enhance the visual development and function of children with low vision. An important strategy within this field is visual stimulation, which is particularly used for infants and toddlers with low vision, as well as for children who have both developmental disabilities and low vision.This study has two primary objectives.The first objective is to examine the effect of using intensive, specific, and flickering black-and-white checkerboard patterns to enhance visual function in children with mild to moderate low vision. The second objective is to develop a visual stimulation program tailored for children with severe or profound multiple disabilities and visual impairments, and to evaluate its effectiveness.
Interested in participating?
Request Info1 month–12 year
All sexes
Interventional
Not applicable
Taipei, Taiwan
Location status: Recruiting
Investigators will recruit 200 children with various types and severities of visual disorders. Additionally, investigators will collect eye movement assessment data using an eye-tracking system from 30 typically developing infants under two years old to validate the oculomotor assessment newly designed for this study. For this component, the reliability of our oculomotor assessment will be validated through test-retest reliability in both typically developing children and children with multiple disabilities and visual impairments who are enrolled in visual rehabilitation.
The intervention programs include two types:
Although this model is flexible and suitable for infants or children with low compliance, it poses challenges in quantifying the amount of visual training provided. This limitation affects the ability to verify the efficacy of interventions in clinical trials.
This version incorporates technical terms and ensures clarity for academic or clinical documentation, while emphasizing the model's flexibility and its limitations.
Researchers adjusted square sizes through trial-and-error and clinical experience, often enlarging the squares to engage the children effectively. However, this strategy may not fully accommodate children with low vision combined with developmental disabilities. Behavioral observations suggest that integrating sVEP to identify occipital response thresholds and utilizing eye-tracking systems could refine square size adjustments and improve intervention strategies and outcome evaluations.
Additionally, this program may not be suitable for children with severe or profound low vision. The need for quick physical or verbal responses to transient oddball stimuli and the requirement to recognize checkerboard patterns demand a certain level of visual acuity and sustained attention. These factors pose challenges for children with severe multiple disabilities (MDVI), who often require longer response times, have shorter attention spans, and struggle with repetitive tasks. Despite these challenges, MDVI children exhibit visual plasticity, making visual stimulation interventions valuable. Developing alternative visual stimulation programs tailored to the needs of children with severe or profound MDVI is essential for maximizing their potential benefits.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Passive visual stimulation group
Inclusion criteria
Exclusion criteria
Perceptual learning group Inclusion Criteria
(1)Significant refractive errors that severely affect vision, where the child cannot adapt to wearing corrective glasses within two training sessions.
(2)Requires occlusion therapy for monocular visual rehabilitation but cannot cooperate with occlusion within two training sessions.
(3)Inability to adapt to the training environment or cooperate with visual training due to emotional instability or difficulty adjusting within two training sessions.
(4)Unstable physiological conditions (e.g., epilepsy, sleep disturbances) that prevent consistent participation in visual training.
black-and-white checkerboard patterns, visual stimulation program, restorative visual rehabitation
Time frame: From enrollment to one year after the end of treatment
Visual Function Battery for Children with Special Needs (VFB-CSN) is typically conducted by occupational therapists with experience in visual rehabilitation. It is a scale used to evaluate the visual function of children with special needs. It assesses eight aspects: visual reflection, eyeball asymmetry, visual acuity, contrast sensitivity, visual field, eye movements, color and shape perception, and visual attention. The scale includes 27 questions and combines standardized tests with functional assessment methods. The functional assessment method can be applied to cases that cannot cooperate with standardized tests. Children with varying degrees of visual impairment, ranging from light perception to identifiable visual targets, can be assessed using the VFB-CSN alone. The assessment scale has a maximum score of 60 and a minimum score of 0, with higher scores indicating better performance.
Time frame: From enrollment to one year after the end of treatment
This questionnaire is completed by the primary caregiver. It is designed for children with severe central nervous system disorders, such as children with cerebral palsy, to evaluate their visual performance under different brightness conditions and during daily activities. The scale consists of 28 questions, with a maximum score of 140 and a minimum score of 28. Higher scores indicate better performance.
Time frame: From enrollment to one year after the end of treatment
The scoring is conducted by occupational therapists with experience in visual rehabilitation, based on their observation of the child's performance. This assessment employs an eye tracker and PowerPoint to create an eye movement assessment program before and after rehabilitation. It evaluates children's abilities in fixation, tracking, and saccadic movements in response to visual stimuli of varying sizes, contrasts, directions, speeds, and positions. The assessment scale has a maximum score of 64 and a minimum score of 8, with higher scores indicating better performance.
Time frame: From enrollment to one year after the end of treatment
Near Detection Scale (NDS) is performed by clinicians specializing in visual issues among children with special needs to quickly assess the detection acuity of children with severe and profound visual impairment. NDS is an 18-point scale, with 0 representing no light perception and 18 representing the ability to see 0.1 cm objects on a dark green background at a viewing distance of 30 cm. Higher scores indicate better visual acuity.
Time frame: From enrollment to one year after the end of treatment
This record is completed by the primary caregiver to document the child's visual behavior at home. The recording is conducted both before and after training to simultaneously capture the child's training activities and response status at home.
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
The Effectiveness of In-person and Telehealth Visual Rehabilitation for Children With Low Vision
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07107646
Eye Diseases, Myopia
Taipei, Taiwan
View Trial DetailsNCT07644468
Autism Spectrum Disorder, Behavior
Taipei, Taiwan
View Trial DetailsNCT07558395
Blindness, Brain Diseases
Vienna, Austria
View Trial DetailsNCT06717282
Autism Spectrum Disorder, Behavior
Taipei, Taiwan
View Trial Details