A Randomized Controlled Trial of ride-on Car Training With a Standing Posture for Enhancing the Effectiveness of Locomotor Experience in Toddlers With Mild and Moderate Motor Delays

Locomotor posture as upright can increase infants' visual availability of destinations and induce their motivation to interact and explore with environment. Using a modified ride-on car (ROC) with a standing posture (ROC-Stand) may result in the similar effects. Our previous world's first randomized controlled trial (RCT) manipulated the parameters of the ROC experience by increasing the demands of postural control during the course of locomotion. The initial findings were positive and inspiring. After an intensive 12-week training program, toddlers with motor delays in the ROC-Stand group had significant improvements in mobility and social function. Moreover, the ROC-Stand group tended to have the most improvements than the ROC-Sit and conventional therapy groups, including mobility, social function and mastery motivation. The ROC-Stand group also had the highest goal achievement scores. In addition, the pilot results of caregivers' perceptions showed over 80% of the caregivers involved in the ROC training programs had decreased concerns on children's motor and social development. Their expectations changed due to the observed improvements in children's movements, cognition, and motivation. The intensive 3-month ROC training program, particularly the standing one, was feasible and beneficial for toddlers with motor delays and their caregivers.

However, the severity level of motor delay should be considered in the early PMDs and require further investigation on the related treatment effects. Thus, a further study of toddlers with different severity levels of motor delays will provide us a full investigation on the effectiveness of ROC-Stand training on mobility, psychosocial function and locomotor experience. Moreover, the integration of information regarding the social looking behaviors, motor cost, caregiver-child interactions and caregivers' perceptions will be beneficial for clarifying the influences of these factors on the outcomes. The purpose of this study is to examine the effectiveness of ROC-Stand training on mobility, psychosocial function and social looking in toddlers with mild and moderate motor disabilities. To obtain the information of social looking and interactions with their caregivers, the investigator will use the lightweight, head-mounted action camera to record children's behaviors. Up to now, there is no ROC-related study applying this methodology to investigate the ecological validity in toddlers with motor delays. This design may help us to capture the novelty and variability of real-world locomotor experience regarding social looking, exploration and interactions.

The specific aims of this study are: 1) to compare the effectiveness of the ROC-Stand training on mobility, psychosocial function and social looking with conventional therapy in toddlers with mild and moderate motor delays, 2) to compare the effectiveness of ROC-Stand training on body function level and environmental factors with conventional therapy in toddlers with mild and moderate motor delays, according to the ICF, and 3) to determine the effects of ROC-Stand training on the relationship among social looking, caregiver-child interactions and mastery motivation in toddlers with mild and moderate motor delays.

Study Design: A randomized, multiple group pretest-posttest control group design will be applied. Four groups will be involved in this project: ride-on car training with a standing posture for toddlers with mild motor delays (ROC-Stand(Mild)), ride-on car training with a standing posture for toddlers with moderate motor delays (ROC-Stand(Mod)), conventional therapy for toddlers with mild motor delays (Control(Mild)) and conventional therapy for toddlers with moderate motor delays (Control(Mod)). The investigator will use stratified randomization. They will be arranged to one of the two groups based on the motor composite (MC) scores assessed by Bayley-III. Subsequently, the participants in each group will be randomly assigned to either the ROC-Stand training program or conventional therapy program by using a computer program (Research Randomizer Form www.randomizer.org). The study duration for each participant is 24 weeks, including a 12-week training phase (intervention) and a 12-week follow-up phase.

There will be 4 groups, including the ROC-Stand(Mild) group (23 toddlers), the ROC-Stand(Mod) group (23 toddlers), the Control(Mild) group (23 toddlers) and Control(Mod) group (23 toddlers). The age group of infants/preschool children is selected based on the previous studies of ROC training in young children with motor disabilities.