Does Dosage Matter: A Randomized Controlled Trial of ride-on Car Training With a Standing Posture to Enhance Social-mobility Function and Motivation in Toddlers With Motor Disabilities

There is increasing evidence of early power mobility training in recent years, which focuses on the outcomes of motivation and socialization by using standardized measurements, including the Dimensions of Mastery Questionnaire (DMQ), the pediatric evaluation of disability inventory (PEDI) and its' computer adaptive test. These studies showed the use of PMDs might increase the child's independent mobility and motivation to master interpersonal tasks and result in positive changes on psychosocial functioning. Previous studies have determined the feasibility of using a modified ride-on car (ROC) as an alternative, novel option for early mobility training to improve independent mobility and socialization in children aged younger than 3 years. Of note is that this technology-focused do-it-yourself (DIY) movement has provided concrete solutions for children with disabilities, which emphasizes "learning by doing" and is called "the Maker Movement". Awori and Lee has viewed the process of modifying the ROCs and applying relevant training as one Maker Movement. Due to the participatory model of innovation, there are over 60 workshops worldwide that have built approximately 5000 ride-on toy cars. In addition to this universal trend of hands-on practice for health innovation, the use of ROCs may result in the significant improvements in motivation and physical activity in young children with motor disabilities.

Kenyon and colleagues reported that pediatric occupational therapists and physical therapists in Canada and the USA recognized the potential benefits of applying power mobility training in young children who have mobility impairments. In addition, almost all therapists agreed or strongly agreed that time and practice were equally as important as a child's abilities when applying power mobility training. However, 69% of these therapists never or seldom provided these types of experiences to children in their practice. The amount and type of practice may play an important role while making the clinical decision. Based on the increased evidence for children with motor disabilities in the past 10-15 years, researchers have suggested that the type of treatment may matter less than the amount of treatment (dosage). The idea of providing an intervention at an amount of greater than standard care has generally been conceptualized with the terms "intensity or intensive treatment". Up to now, several ROC studies have suggested intensive dose of therapy may be effective on improving social-mobility function and mastery motivation. Although the participants were able to complete the 12-week training, the caregivers felt it may be difficult to implement such program in their clinical settings. Our previous pilot results have shown that 85% of the caregivers preferred a 1-hr program than a 2-hr program due to the family resources and geographical concerns. The current ROC training program typically involves long length (9-12 weeks), high frequency (2 sessions per week) and duration (2 hours per session). However, the high frequency and duration may not be a feasible protocol for therapists and caregivers. In addition, there is no study comparing the same type of ROC training at contrasting doses and therefore could not address the relative effectiveness of different doses of therapy. A further study with the comparison of different doses of training may help to determine the optimal program for enhancing social-mobility and psychosocial functions in toddlers with motor disabilities.

It is important to consider the clients' needs and incorporate the suggestions into the training protocol based on the evidence. To integrate the caregivers' feedback and increase the applicability of the ROC training program, the investigator further propose a modified program of using the ROC with less-intensive doses, i.e., a 1 hour session of 30-to-35-minute standing-driving for exploration and 25-minute natural play for exploration and skills training. The investigator assume the less-intensive dose of the ROC training will also have positive effects on social-mobility function and other ICF levels due to the sufficient amount of practice suggested by previous evidence (at least 20 to 60 min. moderate to vigorous intensity/per session, 2 sessions/per week). A 3-group comparison design of different doses of ROC training with a standing posture may provide us a complete examination on the topic of dose-response effect on mobility and psychosocial function in toddlers with disabilities. In this study, the investigator will modify the ride-on toy car (standing style) for toddlers with disabilities for the use in the public spaces in the university for 12 weeks based on our previous RCT study. This RCT will compare the improvements of social-mobility function, mastery motivation and physical activity resulting of different dosages for the ROC use with a standing posture. A control group which receives no ROC training and only involves regular therapy will be applied as an active control group.

The specific aims of this study are: 1) to compare the effectiveness of different dosages of ROC training with a standing posture on social-mobility function, mastery motivation and physical activity in toddlers with motor disabilities; 2) to determine the optimal dosage of ROC training with a standing posture that is needed to enhance social-mobility function, mastery motivation and physical activity in toddlers with motor disabilities; and 3) to examine the effects of different dosages of ROC training with a standing posture on the ICF functioning levels, family perceptions and participation.

Study Design: A randomized, multiple group pretest-posttest control group design will be applied.62 Three groups will be involved in this novel project: the dosage of a 48-hour ROC training program with a standing posture (ROC-48), the dosage of a 24-hour ROC training program with a standing posture (ROC-24), and a regular therapy program without receiving any ROC training (control). The participants will be randomly assigned to one of the 3 groups by using a computer program (Research Randomizer Form www.randomizer.org). The study duration for each participant is 24 weeks, including 12-week intervention and 12-week follow-up.