Short-term and Long-term Effectiveness of Different Dosage Parameters in Looking Behaviors, Functional Skills and Caregiver-child Interaction of Early Powered Mobility Training for Toddlers With Motor Delays

To evaluate the varying dosages' impact, the pilot RCT studied two different intensity levels of the ROC-Stand training for toddlers with motor delays. Initial findings suggest that the 48-hour regimen (2 hours per session, 2 sessions weekly) and the 24-hour approach (1 hour per session, 2 sessions weekly) have beneficial effects on the mobility and social functionalities of the toddlers. While enhancements were observed across the board during the 12-week intervention and follow-up phases, it was the ROC-48 group that showcased the most significant number of participants achieving clinically meaningful changes. This data implies that a 48-hour dose of ROC-Stand training may be the optimal requirement for noted improvements. Furthermore, another pilot study involving two participants using a lightweight, head-mounted eye-tracker by Positive Science, LLC during the ROC training phase has highlighted a positive trend in visual behaviors. Post-training, there was a noticeable increase in participants' interactions with their surroundings, particularly during social encounters and navigation. On the flip side, the frequency with which they observed faces and bodies reduced. The integration of eye-tracking technology showcases its potential in gauging participants' behaviors during self-initiated movements and interactions with the environment and caregivers. It offers a promising avenue to discern the type of visual and social cues acquired during early powered mobility training, aiding in comprehending environmental factors' influence on the psychosocial functions in toddlers with motor delays.

This study seeks to address the quest for determining the minimal effective dosage and to bolster its clinical utility in Taiwan. The research intends to contrast the effectiveness of two intensity levels of the ROC-Stand training, namely 2-hour and 1-hour sessions, targeting children aged between 1-3 at the outset of the intervention. With a 1-year follow-up, the study will not only provide insights into the ROC-Stand training but will also introduce a control group receiving the conventional 1-hour weekly therapy. To ensure consistency, each group will be subjected to the same frequency and duration, totaling 48 hours of intervention. This design of three-group comparison will enable us to define precise dosing benchmarks, incorporating a 2-hour ROC-Stand session (ROC-Stand(2-hr)), a 1-hour ROC-Stand session (ROC-Stand(1-hr)), and a 1-hour conventional therapy session (Control(1-hr)). Pinpointing these intensity benchmarks is vital for guiding clinical decisions and influencing health policy. In addition, the study's incorporation of a novel head-mounted eye-tracker, specifically tailored for young movers, anticipates capturing the nuances and diversities of real-world mobility interactions.

Method: This study will use a randomized, multi-group pretest-posttest control group design. Each group will undergo an intervention with a consistent frequency and duration, specifically, 2 sessions per week culminating in a total of 48 hours of training. The study will utilize a 3-group comparison structure, focusing on two distinct intensity levels. Building on previous research and the aims of this study, the three groups will be distinguished by the intensity of their respective training sessions: The ROC-Stand(2-hr) group will participate in 2-hour sessions twice a week for a total of 12 weeks (3 months). In contrast, both the ROC-Stand(1-hr) and Control(1-hr) groups will attend 1-hour sessions twice weekly for a period of 24 weeks (6 months).

Participants: The study will involve 30 toddlers aged between 12 to 36 months, all exhibiting motor delays. These participants will be randomly allocated to one of three groups: ROC-Stand(2-hr) (10 toddlers), ROC-Stand(1-hr) (10 toddlers), or Control(1-hr) (10 toddlers). Given the emphasis on early powered mobility training, the sample size determination hinges on an effect size f of 0.3, derived from preliminary PEDI-C mobility function data. With a power set at 0.8, a two-sided type I error rate of 0.05, anticipated 20~25% attrition, and drawing from recruitment patterns in past studies, the resulting requisite total sample size is estimated at 30 toddlers.

Recruitment: The participants will be recruited from self-referrals, health care practitioners, or the hospitals in Taoyuan or New Taipei where toddlers with motor delays are receiving outpatient rehabilitation. Children of parents/guardians who provide informed consent will participate in the study.