Rehabilitation Training Games for Children With Amblyopia

Zhu Dian

Status: Enrolling

Conditions: Child Behavior; Adherence, Treatment; Amblyopia; Amblyopia Occlusion

Treatments: Device: Find You! Cure My Animal Friends; Device: DuoBao Vision Training System

Study type: Interventional

Funder types: Other

Identifiers

NCT06372548

NEADS0004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 7 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups

Find You! Cure My Animal Friends

Experimental group

Description:

Participants in the experimental group completed the game in this app. The goal of the game is to guide the amblyopic children to develop the habit of rehabilitation training, so that the amblyopic children will keep their interest in completing the exercises according to the time in the game. A story of an animal intern doctor is constructed, and the player will play the role of an animal doctor according to the guidance of the plot, wear the corresponding eye patches and complete the set visual training tasks in the game. The study aims to improve the overall treatment adherence by increasing the attractiveness of the visual training game to children, cultivating long-term training habits, and mitigating the negative effects of amblyopia treatment. The path to achieve this goal consists of the following components: (1) narrative content, (2) interactive forms combined with masking therapy, (3) incentives, and (4) visual design that is consistent with children's preferences.

Treatment:

Device: Find You! Cure My Animal Friends

DuoBao Vision Training System

Active Comparator group

Description:

Software Co.'s DuoBao Vision Training System. A number of visual function tests and ophthalmology strabismus amblyopia specialist examinatio. The data is transmitted to the data center and the expert intelligent system to develop a targeted personalized amblyopia training program. Control group participants completed the training components in this app.

Treatment:

Device: DuoBao Vision Training System