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

In recent years, modified ride-on toy cars (ROCs) have become an innovative treatment option to enhance independent mobility and socialization in young children with disabilities, and been viewed as one Maker Movement. Our previous randomized controlled trial (RCT) provided the highest level of evidence supporting the positive effects of ROC training with a standing posture (ROC-Stand training) on mobility and social function in toddlers with motor delays. It was the world’s first study to show ROC-Stand training may result in more positive changes than the sitting one and the regular therapy. However, the heterogeneity of the participants regarding severity level of motor delays and environmental considerations may be the factors contributing to the different treatment effects. To provide a full investigation of the effectiveness of ROC-Stand training, this study proposes to compare the effects on toddlers with mild and moderate motor delays. Additionally, the lightweight, head-mounted action camera will be applied as the novel method to record and compare children’s locomotor experience of social looking and interactions during the training phase. The three purposes 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 International Classification of Functioning, Disability and Health (ICF) levels, 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. Based on the power analysis from the preliminary results of the pilot study, we will recruit 92 toddlers with motor delays and further assign them to either mild or moderate motor delays group. The participants in each group will be randomly assigned to either the ROC-Stand training program or conventional therapy(Control) program, resulting the following four training groups: the ROC-Stand(Mild) group (n=23), the ROC-Stand(Mod) group (n=23), Control(Mild) group (n=23), and Control(Mod) group (n=23). The whole study duration will be 24 weeks, including a 12-week intervention and a 12-week follow-up. All programs will include 120 minutes/per session, 2 sessions/per week. Participants will continue their regular therapy during the whole study. Standardized assessments are provided for a total three times, including the time before and after the intervention and in the end of the follow-up phase. The head-mounted cameras worn by the participants and caregivers will record the social looking and interaction behaviors for one 2-hour session/per week during intervention. Participants will also wear three accelerometers throughout the 2-hour training. Assessments include mobility, socialization, behavioral coding, body function, family perception and participation. The findings of this study will provide us some optimal, alternative ways to enhance locomotor experience depending on each child's and family's needs.

Project ID:PC10907-1054
External Project ID:MOST109-2314-B182-032