Using eye-tracking and mobility training to help toddlers with motor disabilities
Using Head-mounted, Eye-tracking to Compare Looking, Manual Exploration and Social Interaction During Active Locomotion in Toddlers With Mild, Moderate and Severe Motor Delays: A Randomized Controlled Trial
This study is testing if using eye-tracking technology along with a ride-on car can help toddlers with motor delays move better and interact more with their caregivers compared to regular therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 1 Year to 3 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 2 sites (Taoyuan City, Taoyuan County and 1 other locations) |
| Trial ID | NCT05441137 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility of using head-mounted eye-tracking technology to enhance visual and manual exploration in toddlers with varying levels of motor delays. It will compare the effectiveness of a ride-on car (ROC) training program against conventional therapy, focusing on outcomes related to mobility and caregiver-child interactions. The study will recruit 72 toddlers, categorizing them into groups based on the severity of their motor delays, and will utilize random assignment to determine the training approach for each child.
Who should consider this trial
Good fit: Ideal candidates are toddlers aged 1 to 3 years with motor delays that prevent independent walking but who can stand with support.
Not a fit: Patients with severe sensory impairments or those who exceed the height and weight criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve mobility and interaction skills in toddlers with motor disabilities, enhancing their overall development.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. motor delays that resulted in motor impairments preventing independent walking (standard deviation \[SD\] \<-1.5, assessed by the Chinese Child Development Inventory via a pediatric physician) 2. being able to stand independently for two seconds or tolerate standing with support for 10 minutes 3. being able to reach objects with either one or both hands 4. 69 to 103 cm height and 7 to 18 kg weight 5. parents agreeing to provide consent for their child's participation in the training program Exclusion Criteria: 1. children with severe sensory impairments (including blindness or deafness) 2. exceeding the height or weight criteria 3. parents/guardians who were unable to make the time commitment for the program and children with severe emotional disorders resulting in strong reactions and causing possible harms.
Where this trial is running
Taoyuan City, Taoyuan County and 1 other locations
- Chang Gung University — Taoyuan City, Taoyuan County, Taiwan (Recruiting)
- Linkou Chang Gung Memorial Hospital — Taoyuan City, Taoyuan County, Taiwan (Recruiting)
Study contacts
- Principal investigator: Hsiang-Han Huang, ScD — Chang Gung University
- Study coordinator: Hsiang-Han Huang, ScD
- Email: hsianghan@mail.cgu.edu.tw
- Phone: +886-3-2118800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.