Actively Recruiting

Phase Not Applicable
Age: 10Months - 40Months
All Genders
ID06928077

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

Led by Chang Gung Memorial Hospital · Updated on 2025-04-15

30

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how using a lightweight head-mounted eye tracker (HMET) can help understand looking behavior, visual focus, and social interaction in toddlers with motor delays during power mobility training. The study compares training with specific environmental features, training without these features, and conventional therapy. It also evaluates outcomes related to body function, daily activities, participation, family perceptions, and explores how temperament, motivation, and caregiver-child interactions relate across these training programs. The study involves 30 toddlers aged 1 to 3 years with motor delays, randomly assigned to one of three groups: ROC-Stand training with specific environmental features (ROC-Stand(SE)), ROC-Stand training without specific environmental features (ROC-Stand(NSE)), and conventional therapy (Control), with 10 toddlers in each. Each toddler will receive 48 hours of training over 24 weeks, with two 2-hour sessions per week for 12 weeks, followed by a 12-week follow-up. Participants will continue their regular therapy throughout. During training, toddlers wear the HMET weekly for 20 minutes to record eye gaze and manual actions. Participants will undergo assessments before the intervention, after 12 weeks of training, and after the 12-week follow-up. These assessments include standardized tests of body function, mobility, psychosocial function, family perception, and participation. An activity log and caregiver feedback are collected weekly. The study aims to identify key environmental factors for early power mobility training and provide families and therapists with structured guidance on these techniques.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 10Months - 40Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 1 to 3 years
  • Have motor delays preventing independent walking or requiring assistive technology, defined as more than 1.5 standard deviations below the mean
  • Able to stand independently for at least two seconds or tolerate standing with support for up to 10 minutes
  • Capable of reaching for objects with one or both hands
  • Height between 69 to 103 cm and weight between 7 to 18 kg
  • Parents able to provide consent for participation
Not Eligible

You will not qualify if you...

  • Severe sensory impairments such as blindness or deafness
  • Height outside 69 to 103 cm or weight outside 7 to 18 kg
  • Parents or caregivers unable to commit time for training
  • Severe emotional reactions that could lead to harm

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - 12 weeks

Participants take part in a 12-week training program consisting of 2-hour sessions twice a week. Depending on group assignment, they receive ROC-Stand training with or without specific environmental features, or conventional therapy. During this period, participants wear a lightweight head-mounted eye tracker once a week for a 20-minute session to record looking behaviors and interactions.

Twice-weekly 2-hour training sessions and 1 weekly 20-minute eye-tracking session

Follow-up

Duration - 12 weeks

Participants continue their regular therapy sessions at their clinics without additional training from the study team. Assessments and data collection occur at three time points: before training, after the 12-week intervention, and after the 3-month follow-up period.

Assessments at three time points: before training, after 12 weeks of training, and after 12 weeks of follow-up

Trial Site Locations

Total: 1 location

1

Chang Gung University

Taoyuan City, Taoyuan County, Taiwan, 33302

Actively Recruiting

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Research Team

H

Hsiang-Han Huang, ScD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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