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临床试验/NCT06928077
NCT06928077招募中不适用

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

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月7日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Looking Behaviors, Visual Fixation, and Social Interactions Assessed Using the Positive Science Head-Mounted Eye Tracker (HMET)

研究概览

简要总结

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.

详细描述

Environmental and task modifications are widely used in pediatric rehabilitation to help shape children's actions. However, therapists often adjust these factors by trial and error. A better understanding of how to optimize the "fit" between a child and their surroundings could lead to a more systematic approach, making it easier for children to develop new actions. Head-mounted eye trackers (HMETs) are wearable devices that record eye movements in real-world settings. By combining ROC (ride-on car) training with HMET technology, the investigators can track the visual and touch-based information that young children gather as they use power mobility devices (PMDs). This new approach helps to see how toddlers interact with their environment, deepening our understanding of their development.

This research project focuses on three key aims: 1) Evaluating the effects of ROC-Stand training programs, both with and without specific environmental features, on the looking behaviors and social interactions of toddlers with motor delays, compared to a control group receiving conventional therapy; 2) Determining the effectiveness of these programs in achieving various outcomes as categorized by the International Classification of Disability, Functioning, and Health (ICF) framework for toddlers with motor delays; and 3) Investigating how these training programs affect the relationship among children's temperament, mastery motivation, looking behaviors, and caregiver-child interactions in toddlers with motor delays.

Study design: The investigators will use a randomized, pretest-posttest control group design with three groups. The study will involve a three group comparison: two ROC training programs, differentiated by the inclusion (ROC-Stand(SE)) or exclusion (ROC-Stand(NSE)), of specific environmental features, and a control group receiving conventional therapy. All groups will have an identical training schedule: 2-hour sessions, conducted twice a week for a 12-week period. The duration of the study for each participant is set at 6 months, which includes a 3-month intervention period followed by a 3- month follow-up phase. Participants will continue their regular therapy sessions throughout the study.

Participants: The study will include 30 toddlers, aged between 12 to 36 months, who have motor delays. These participants will be randomly assigned into three groups, each consisting of 10 toddlers: the ROC-Stand(SE) group, the ROC-Stand(NSE) group, or the Control group. The sample size for our study on early powered mobility training is determined based on an effect size (f) of 0.3, as observed in a previous ROC-Stand RCT that assessed social function in PEDI-C. This calculation takes into account a statistical power of 0.8, a two-sided type I error rate of 0.05, an anticipated dropout rate between 20 to 25%, and recruitment conditions from prior studies.

Recruitment: Participants will be recruited through self-referrals, healthcare practitioners, and hospitals in Taoyuan or New Taipei where toddlers receive outpatient rehabilitation. Flyers will be distributed in clinical settings, and interested parents will be contacted to explain the study details. Informed consent will be obtained before enrollment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
10 Months 至 40 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Looking Behaviors, Visual Fixation, and Social Interactions Assessed Using the Positive Science Head-Mounted Eye Tracker (HMET)

时间窗: Once per week during the intervention phase, for a 20-minute session (weekly for 12 weeks)

Participants' visual behaviors and social interactions will be assessed weekly during the training phase using the Positive Science Head-Mounted Eye Tracker (HMET). This objective eye-tracking system includes a 46 g lightweight headgear, a cap, wireless transmitter, and battery pack (total weight 271 g). An infrared eye camera tracks the participant's right eye movements, and a forward-facing scene camera captures the environment with a 90° field of view. Live Capture software (Positive Science) records synchronized eye and scene videos at 30 Hz. Eye-tracking calibration is conducted using Yarbus software (Positive Science), which generates gaze point visualizations with a 4° radius marker on each video frame. A trained therapist monitors recordings in real time. Each participant will be recorded for 20 minutes per week during the training period. Videos will be coded offline using a protocol adapted from established infant research. Coded behaviors include looking at faces, bodies,

次要结局

  • The Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-III)(The test will be administered on three occasions: before and after the 3-month intervention (T1 & T2) and the end of the 3-month follow up phase (T3).)
  • Toddler Temperament Scale (TTS)(The test will be administered on three occasions: before and after the 3-month intervention (T1 & T2) and the end of the 3-month follow up phase (T3).)
  • Peabody Developmental Motor Scales - Third edition (PDMS-3)(The test will be administered on three occasions: before and after the 3-month intervention (T1 & T2) and the end of the 3-month follow up phase (T3).)
  • The Revised Dimensions of Mastery Questionnaire (DMQ 18) - Chinese version(The test will be administered on three occasions: before and after the 3-month intervention (T1 & T2) and the end of the 3-month follow up phase (T3).)
  • The Chinese version of Pediatric Evaluation of Disability Inventory (PEDI-C)(The test will be administered on three occasions: before and after the 3-month intervention (T1 & T2) and the end of the 3-month follow up phase (T3).)
  • Goal Attainment Scale (GAS)(The test will be administered on three occasions: before and after the 3-month intervention (T1 & T2) and the end of the 3-month follow up phase (T3).)
  • The Chinese version of the Affordance in the Home Environment for Motor Development - Toddler version (AHEMD-Toddler-C)(The test will be administered on three occasions: before and after the 3-month intervention (T1 & T2) and the end of the 3-month follow up phase (T3).)
  • The Parenting Stress Index Short Form (PSI/SF)(The test will be administered on three occasions: before and after the 3-month intervention (T1 & T2) and the end of the 3-month follow up phase (T3).)
  • Activity Log(The test will be administered on three occasions: before and after the 3-month intervention (T1 & T2) and the end of the 3-month follow up phase (T3).)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsiang-Han Huang

Associate Professor

Chang Gung Memorial Hospital

研究点 (2)

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