Rehabilitation Training Games for Children With Amblyopia

NCT06372548 | Completed

• 1 other identifier: NEADS0004
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia; Amblyopia Occlusion; Child Behavior; Adherence, Treatment

Outcome Measures

Primary Outcomes (1)

• 8-Item Morisky Medication Adherence Scale (MMAS-8):

  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.

  baseline and study completion (after 8 weeks)

Secondary Outcomes (1)

• User Experience Questionnaire (UEQ)

  study completion (after 8 weeks)

Study Arms (2)

Find You! Cure My Animal Friends

EXPERIMENTAL

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.

Device: Find You! Cure My Animal Friends

DuoBao Vision Training System

ACTIVE COMPARATOR

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.

Device: DuoBao Vision Training System

Interventions

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.

Find You! Cure My Animal Friends

DuoBao Vision Training System DEVICE

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

DuoBao Vision Training System

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhu Dian: lead

Study Sites (1)

Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200240, China

Location

MeSH Terms

Conditions

Amblyopia; Child Behavior; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Health Behavior

Study Officials

• Dian Zhu, Dr

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 18, 2024
• Study Start: March 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 30, 2026

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)