Rehabilitation Training Games for Children With Amblyopia

Amblyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372548
• Other study ID #: NEADS0004
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: April 2024
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Zhao Liu, prof
• Phone: +8618901626266
• Email: hotlz[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Treatment
• Amblyopia
• Amblyopia Occlusion
• Child Behavior

Intervention

Device:
• 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.
• DuoBao Vision Training System
This is a visual training app where participants are required to complete several training tasks.

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhu Dian

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	User Experience Questionnaire (UEQ)	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	study completion (after 8 weeks)