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

NCT06928077 | Recruiting

• 1 other identifier: 113WFD2610113
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Young Children With Motor Disabilities

Outcome Measures

Primary Outcomes (1)

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

  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,

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

Secondary Outcomes (9)

• 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).

Study Arms (3)

ROC-Stand training with specific environmental features (ROC-Stand(SE))

ACTIVE COMPARATOR

Each session will last for 2 hours, occurring twice a week over a 12-week intervention period, and will be based on ecological and dynamic systems theories.Weekly, the research team will assist participants in wearing a lightweight HMET to record the first 10 minutes of both the driving and natural play sessions during each 2-hour training session. This will result in a total dataset of 20 minutes per session. Each training session structure includes a 70-minute driving session and a 40-to-50-minute natural play session, with an optional 10-minute break, as needed, in line with ROC-related studies. These discussions and coaching methods will also be informed by clinical observations of the participant's performance in prior sessions.

Behavioral: ROC-Stand training with specific environmental features

ROC-Stand training without specific environmental features (ROC-Stand(NSE))

ACTIVE COMPARATOR

The same therapist responsible for the ROC-Stand(NSE) group will oversee the program. This group's training frequency will match that of the ROC-Stand(SE) group, adhering to training principles similar to those employed in previous ROC training studies in various environments. Furthermore, during each training session, participants will wear the HMET for 20 minutes, capturing the initial 10 minutes of both the driving and natural play segments.

Behavioral: ROC-Stand training without specific environmental features

Conventional therapy (Control)

ACTIVE COMPARATOR

The frequency and duration of these sessions are identical to those in the ROC training groups, with objectives tailored to enhance specific motor or psychosocial skills relevant to each participant's current developmental stage. They will also wear the HMET for the first 20 minutes of one training session each week, enabling the collection of similar data to that gathered from the ROC training groups.

Behavioral: Conventional therapy

Interventions

ROC-Stand training with specific environmental features BEHAVIORAL

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.

ROC-Stand training with specific environmental features (ROC-Stand(SE))

ROC-Stand training without specific environmental features BEHAVIORAL

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.

ROC-Stand training without specific environmental features (ROC-Stand(NSE))

Conventional therapy BEHAVIORAL

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.

Conventional therapy (Control)

Eligibility Criteria

• Age: 10 Months - 40 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung University

Taoyuan, Taoyuan County, 33302, Taiwan

RECRUITING

Study Officials

• Hsiang-Han Huang, ScD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiang-Han Huang, ScD

CONTACT

+886-3-2118800; hsianghan@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 15, 2025
• Study Start: April 7, 2025
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

TW (1)