NCT06000631 Long-term Effectiveness of Different Dosage Parameters of Early Powered Mobility Training for Toddlers With Motor Delays
| NCT ID | NCT06000631 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Young Children With Motor Disabilities |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-08-30 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-08-30 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The three purposes of this study are: 1) to compare the effects on looking behaviors, visual fixation and social interaction through the use of a head- mounted, eye-tracker in toddlers with motor disabilities after receiving different intensity levels of ROC-Stand training; 2) to compare short-term and long-term outcomes in terms of body function, activity and participation across the ICF framework, family perceptions and participation; and 3) to identify factors that predict individual differences in outcomes for toddlers with motor delays with the two dosing protocols. Based on the power analysis from the pilot study, the investigators will recruit 30 toddlers with motor delays and further randomly assign the participants to the 3 groups with the same total amount of 48-hour training, including 2 ROC-Stand groups and 1 conventional therapy group, i.e., an intensity level of 2-hour session of ROC-Stand training (ROC-Stand(2-hr)) (n=10), an intensity level of 1-hour session of ROC-Stand training (ROC-Stand(1-hr)) (n=10), and an intensity level of 1-hour session of conventional therapy (Control(1-hr)) (n=10). The training frequency for the 3 groups is 2 sessions/per week. The whole study duration will be 1 year. The head-mounted cameras worn by the participants will record the visual and interactive behaviors for 20 minutes/per week during intervention. Standardized assessments are provided for a total 4 times, including the time before training (T1), 3 months following initiation of training (T2), 6 months following initiation of training (T3), and the end of a year following initiation of training (T4). Assessments include body function, activity and participation across the ICF domains, family perception and participation. The findings of this study will provide guidelines for adjusting the dosage parameters of early powered mobility depending on each child's and family's needs.
Eligibility 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
Contact & Investigator
Hsiang-Han Huang, ScD
PRINCIPAL INVESTIGATOR
Chang Gung University
Frequently Asked Questions
Who can join the NCT06000631 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 3 Years, studying Young Children With Motor Disabilities. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06000631 currently recruiting?
Yes, NCT06000631 is actively recruiting participants. Contact the research team at hsianghan@mail.cgu.edu.tw for enrollment information.
Where is the NCT06000631 trial being conducted?
This trial is being conducted at Taoyuan City, Taiwan, Taoyuan City, Taiwan.
Who is sponsoring the NCT06000631 clinical trial?
NCT06000631 is sponsored by Chang Gung Memorial Hospital. The principal investigator is Hsiang-Han Huang, ScD at Chang Gung University. The trial plans to enroll 30 participants.