Evaluating the effects of powered mobility training on toddlers with motor delays
Short-term and Long-term Effectiveness of Different Dosage Parameters in Looking Behaviors, Functional Skills and Caregiver-child Interaction of Early Powered Mobility Training for Toddlers With Motor Delays
This study is testing how different amounts of ROC-Stand training can help toddlers with motor delays improve their movement, attention, and social skills compared to regular therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (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 | NCT06000631 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the long-term effectiveness of different dosage parameters of ROC-Stand training for toddlers with motor disabilities. It will compare the impact of varying intensity levels of training on looking behaviors, visual fixation, and social interaction using a head-mounted eye-tracker. Additionally, the study will evaluate short-term and long-term outcomes related to body function, activity, and family participation. A total of 30 toddlers will be randomly assigned to three groups to receive either 2-hour or 1-hour sessions of ROC-Stand training or conventional therapy over a specified period.
Who should consider this trial
Good fit: Ideal candidates for this study are toddlers aged 1-3 years with motor delays that prevent independent walking.
Not a fit: Patients with severe sensory impairments or those who exceed the height or weight criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance mobility and social interaction in toddlers with motor delays, leading to improved developmental outcomes.
How similar studies have performed: Previous pilot studies have shown promising results with similar approaches, indicating potential effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age between 1-3 years old 2. motor delays that resulted in motor delays that prevented independent walking (\> 1.5 standard deviation \[SD\] below the mean, assessed by the Chinese Child Development Inventory via a pediatric physician) 3. being able to stand independently for two seconds or tolerate standing with support for 10 minutes 4. being able to reach objects with either one or both hands 5. 69 to 103 cm height and 7 to 18 kg weight 6. 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 are unable to make the time commitment for the program 4. children with severe emotional reactions which may result in harm
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.