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Tests treatment safety and results for Young Children With Motor Disabilities
Official title Long-term Effectiveness of Different Dosage Parameters of Early Powered Mobility Training for Toddlers With Motor Delays
ClinicalTrials.gov ID: NCT06000631
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 3
You may be able to join if
- age between 1-3 years old
- motor delays that resulted in motor delays that prevented independent walking (\> 1.5 standard deviation [SD] below the mean, assessed by the Chinese...
- being able to stand independently for two seconds or tolerate standing with support for 10 minutes
- being able to reach objects with either one or both hands
- 69 to 103 cm height and 7 to 18 kg weight
You likely can't join if
- children with severe sensory impairments (including blindness or deafness)
- exceeding the height or weight criteria
- parents/guardians who are unable to make the time commitment for the program
- children with severe emotional reactions which may result in harm
See the full eligibility criteria
- age between 1-3 years old
- 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)
- being able to stand independently for two seconds or tolerate standing with support for 10 minutes
- being able to reach objects with either one or both hands
- 69 to 103 cm height and 7 to 18 kg weight
- parents agreeing to provide consent for their child's participation in the training program
- children with severe sensory impairments (including blindness or deafness)
- exceeding the height or weight criteria
- parents/guardians who are unable to make the time commitment for the program
- children with severe emotional reactions which may result in harm
The study team makes the final eligibility decision.
Where it's taking place
- Taoyuan City, Taoyuan County, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 3 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taoyuan City, Taoyuan County, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.