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Completed

NCT Number: NCT06372548

Rehabilitation Training Games for Children With Amblyopia

A gamification product was developed to guide children with amblyopia to develop rehabilitation training habits by combining cognitive evaluation theory and occlusion therapy. A randomized controlled trial was conducted to examine the ease of use, acceptability and treatment compliance of the game.

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Key information

Conditions

Amblyopia Adherence, Treatment Amblyopia Occlusion Behavior Brain Diseases Central Nervous System Diseases Child Behavior Eye Diseases Health Behavior Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Treatment Adherence and Compliance Vision Disorders

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200240, China

About this study

The experimental group was subjected to a 20-minute daily, 4-week intervention experiment, which included a story background on the start page, eye patches to be put on according to the guidelines, fine eye training, and visual stimulation training, with short breaks between the different modes. The control group was given an experimental intervention using a competing product, with the same duration and format as the experimental group. After completion of the intervention, the participating children completed the MMAS-8 adherence scale with the help of their parents.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of amblyopia (including refractive amblyopia, strabismic amblyopia and mixed).
  • The child has no significant IQ deficits and has no difficulty communicating with others.
  • The children's teachers and parents gave their informed consent to participate in the experiment. The informed consent form was signed by the parents and is shown in the Appendix.

Exclusion criteria

  • Severe amblyopia.
  • Suffering from other psychological or physical disorders.
  • Parents did not agree to sign the informed consent form or the child was not willing to participate in this experiment.

Treatment and study plan

Find You! Cure My Animal Friends

Device

Introduced cognitive evaluation theory combined with masking therapy to develop a gamified product that guides amblyopic children to develop habits for the purpose of rehabilitation training.

DuoBao Vision Training System

Device

This is a visual training app where participants are required to complete several training tasks.

Primary outcomes

  1. 8-Item Morisky Medication Adherence Scale (MMAS-8):

    Time frame: baseline and study completion (after 8 weeks)

    A patient's adherence to therapy can be evaluated using the eight-question Morisky Medication Adherence Scale-8 (MMAS-8).The total score of the MMAS-8 scale is the sum of the scores of the above 8 questions, and the score range is 0~8. Higher scores indicate better medication adherence. 8 indicates good adherence; 6~7 indicates moderate adherence; <6 indicates poor adherence.

Secondary outcomes

  1. User Experience Questionnaire (UEQ)

    Time frame: study completion (after 8 weeks)

    Enabling prompt and accurate user experience measurement is the primary goal of the UEQ.UEQ was administered post-experiment to swiftly and accurately measure user experience. Covering 26 items across six domains, UEQ evaluated the impact of the amblyopia rehabilitation training product on both children and their parents. Due to its language complexity, the questionnaire was completed with parental assistance.1 for disagree, 7 for strongly agree

Sponsors and collaborators

Lead sponsor

Zhu Dian

Other

Registry information

Official study title

The Effect of Cognitive Appraisal Theory on Adherence in Rehabilitation Training Games for Children With Amblyopia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2024
Registry last updated
Apr 30, 2026

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.

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