Rehabilitation Training Games for Children With Amblyopia

NCT ID: NCT06372548

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-08-01

Brief Summary

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.

Detailed 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.

Conditions

Amblyopia; Amblyopia Occlusion; Child Behavior; Adherence, Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Find You! Cure My Animal Friends

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.

Group Type: EXPERIMENTAL

Find You! Cure My Animal Friends

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

DuoBao Vision Training System

Intervention Type: DEVICE

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

Interventions

Find You! Cure My Animal Friends

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.

Intervention Type: DEVICE

DuoBao Vision Training System

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhu Dian

OTHER

Sponsor Role: lead

Responsible Party

Zhu Dian

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dian Zhu, Dr

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhao Liu, prof

Role: CONTACT

hotlz@sjtu.edu.cn

+8618901626266

Facility Contacts

Zhao Liu

Role: primary

hotlz@sjtu.edu.cn

+8618901626266

Other Identifiers

NEADS0004

Identifier Type: -

Identifier Source: org_study_id