Actively Recruiting

Phase Not Applicable
Age: 1Year - 3Years
All Genders
ID06000631

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

Led by Chang Gung Memorial Hospital · Updated on 2024-01-11

30

Participants Needed

2

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying toddlers aged 1 to 3 years with motor delays that affect their ability to walk independently. The study compares the effects of different intensity levels of early powered mobility training, called ROC-Stand, on looking behaviors, visual fixation, and social interaction. It also evaluates short-term and long-term outcomes related to body function, activity, participation, family perceptions, and caregiver-child interaction. The goal is to identify which training intensity best supports development and to understand individual differences in response to these treatments. Participants are randomly assigned to one of three groups: a 2-hour session of ROC-Stand training twice a week for 12 weeks, a 1-hour session of ROC-Stand training twice a week for 24 weeks, or a 1-hour session of conventional therapy twice a week for 24 weeks. Each session includes activities like goal-oriented driving in public spaces and natural play, with a focus on motor skills and socialization. During training, toddlers wear a lightweight head-mounted eye-tracker to record their visual and interactive behaviors. All groups continue their regular therapy throughout the year-long study. Participants undergo assessments at four points: before training, and at 3, 6, and 12 months after starting. These include standardized developmental tests, family perception questionnaires, and activity logs. Eye-tracking data are analyzed by trained coders to evaluate looking and social behaviors. Researchers monitor training conditions, caregiver feedback, and therapy outside the study. The primary outcome measures changes in looking and fixation behaviors over 24 weeks, while secondary outcomes assess developmental progress, motor skills, family stress, and participation. The study spans one year to capture both immediate and lasting effects of the interventions.

CONDITIONS

Brief Title

Long-term Effectiveness of Different Dosage Parameters of Early Powered Mobility Training for Toddlers With Motor Delays

Who Can Participate

Age: 1Year - 3Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 1 and 3 years old
  • Motor delays preventing independent walking (more than 1.5 standard deviations below the mean)
  • Ability to stand independently for at least two seconds or tolerate standing with support for 10 minutes
  • Ability to reach objects with one or both hands
  • Height between 69 and 103 cm and weight between 7 and 18 kg
  • Parent or guardian provides consent for participation
Not Eligible

You will not qualify if you...

  • Severe sensory impairments, including blindness or deafness
  • Height or weight outside the specified ranges
  • Parents or guardians unable to commit the required time for the program
  • Severe emotional reactions in the child that may cause harm

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Intervention

Duration - 12 to 24 weeks depending on group assignment

Participants receive early powered mobility training or conventional therapy based on their assigned group, involving sessions in a public space with licensed therapists and caregivers. Training includes using a lightweight head-mounted eye-tracker to record looking and interactive behaviors weekly.

2 sessions per week with weekly eye-tracking during one session

Follow-up

Duration - Up to 1 year after intervention start

Participants continue their usual therapy outside the study while being observed for long-term effects without additional study training programs.

Assessments at 3, 6, and 12 months after starting training

Trial Site Locations

Total: 2 locations

1

Chang Gung University

Taoyuan City, Taoyuan County, Taiwan, 33302

Actively Recruiting

2

Linkou Chang Gung Memorial Hospital

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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