RecruitingNot ApplicableNCT06928077

Inspiration From Eye-tracking Data: Investigating the Impact of Combining Specific Environmental Features and Power Mobility Training

Inspiration From Eye-tracking Data: Investigating the Impact of Combining Specific Environmental Features and Power Mobility Training on Functional Skills and Caregiver-child Interaction in Toddlers With Motor Delays


Sponsor

Chang Gung Memorial Hospital

Enrollment

30 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study has three main objectives. First, the investigators want to see how using a lightweight head-mounted eye tracker (HMET) can help to understand looking behavior, visual focus, and social interaction in toddlers with motor delays during ROC-Stand training. The investigators will compare the effects of training with specific environmental features to training without these features and to conventional therapy. Second, the investigators will evaluate outcomes related to body function, daily activities, and participation, along with family perceptions and involvement, using the ICF framework. Third, the investigators will explore how temperament, motivation, looking behavior, and caregiver-child interactions relate to each other in these toddlers across different training programs. Based on previous research, the investigators plan to recruit 30 toddlers with motor delays and randomly assign them to one of three groups: ROC-Stand with specific environmental features (ROC-Stand(SE)), ROC-Stand without these features (ROC-Stand(NSE)), and conventional therapy (Control), with 10 toddlers in each group. Each toddler will receive a total of 48 hours of training over 24 weeks, with two 120-minute sessions per week-12 weeks of intervention followed by a 12-week follow-up. The participants will also continue their regular therapy during the study. The HMET will record visual and manual behaviors for 20 minutes each week, and standardized assessments of body function, mobility, psychosocial function, family perception, and participation will be done before the intervention, after the intervention, and at the end of the follow-up. The findings from this study will help identify key environmental factors for early power mobility training and provide families and therapists with a clear, structured approach to using these techniques.


Eligibility

Min Age: 10 MonthsMax Age: 40 Months

Inclusion Criteria6

  • aged between 1 to 3 years
  • having motor delays that either prevent independent walking or require the use of assistive technology for walking, defined as more than 1.5 standard deviations(SD) below the mean, as evaluated by the Chinese Child Development Inventory via a physician
  • able to stand independently for at least two seconds or can tolerate standing with support for up to 10 minutes
  • capable of reaching for objects with either one or both hands
  • with a height ranging from 69 to 103 cm and a weight between 7 to 18 kg
  • having parents who can provide consent for their child's participation in the training programs

Exclusion Criteria4

  • children with severe sensory impairments, such as blindness or deafness
  • children whose height falls outside the range of 69 to 103 cm and weight outside the range of 7 to 18 kg
  • parents or caregivers who are unable to commit the time required for the training phase
  • children who exhibit severe emotional reactions that could potentially lead to harm

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Interventions

BEHAVIORALROC-Stand training with specific environmental features

A licensed, independent therapist along with caregivers will conduct the training program in a public space at the university. The initial phase of the training will concentrate on developing the participants' understanding of cause-and-effect in relation to the control system and the movement of the car, focusing on specific public spaces such as hallways, convenience stores, gardens, and museums. Following this, the therapist will collaborate with caregivers to direct the participants' gaze towards specific physical structures and objects. Furthermore, the therapist will guide and coach caregivers on how to lead the participants in engaging with these environmental features through various exploratory actions, as supported by previous evidence. These actions include touching, hitting, squeezing, pointing, holding objects with one or two hands, object touching own body, fingering, banging, manipulating, and transferring objects.

BEHAVIORALROC-Stand training without specific environmental features

The initial phase of training will also focus on teaching participants about cause-and-effect as it pertains to the control system and movement of the car. This phase will include goal-oriented driving activities, such as traveling 200 meters to reach a preferred toy or to interact with someone, and engaging in games like hide-and-seek in various public spaces including hallways, convenience stores, gardens, and museums. The training, without a specific emphasis on environmental features, will highlight the use of upper limbs in functional tasks during driving sessions, and incorporate a range of motor skills to enhance mobility and socialization during natural play sessions. The details of the program will also be established through collaborative discussions between the family and the treating therapist. These discussions will take into account clinical observations of the participant's performance in previous sessions.

BEHAVIORALConventional therapy

The overarching goal of this training is to support developmental progress and improve mobility, socialization, and upper limb functionality in everyday tasks. Participants in this group will have the opportunity to walk in the same public space used by the ROC training groups, allowing interaction with both the therapist and caregivers based on their individual motor capabilities.


Locations(1)

Chang Gung University

Taoyuan City, Taoyuan County, Taiwan

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NCT06928077


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