Actively Recruiting
Long-term Effectiveness of Different Dosage Parameters of Early Powered Mobility Training for Toddlers With Motor Delays
Led by Chang Gung Memorial Hospital · Updated on 2024-01-11
30
Participants Needed
2
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Long-term Effectiveness of Different Dosage Parameters of Early Powered Mobility Training for Toddlers With Motor Delays
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 and 3 years old
- Motor delays preventing independent walking (more than 1.5 standard deviations below the mean)
- Ability to stand independently for two seconds or tolerate standing with support for 10 minutes
- Ability to reach objects with either one or both hands
- Height between 69 and 103 cm and weight between 7 and 18 kg
- Parents willing to provide consent for participation
You will not qualify if you...
- Severe sensory impairments such as blindness or deafness
- Height or weight outside the specified ranges
- Parents or guardians unable to commit time for the program
- Severe emotional reactions in the child that may cause harm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Chang Gung University
Taoyuan City, Taoyuan County, Taiwan, 33302
Actively Recruiting
2
Linkou Chang Gung Memorial Hospital
Taoyuan City, Taoyuan County, Taiwan, 33302
Actively Recruiting
Research Team
H
Hsiang-Han Huang, ScD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here