Using Head-mounted, Eye-tracking to Compare Looking, Manual Exploration and Social Interaction During Active Locomotion

Summary

The three purposes of this study are: 1) to determine the feasibility of using a head-mounted eye-tracker and examine the effects of the optimal mobility training on increasing visual and manual exploration in toddlers with different severity levels of motor delays, 2) to compare the effectiveness of providing optimal mobility training on outcomes across the ICF framework in toddlers with mild, moderate and severe motor delays, and 3) to determine the effects of optimal mobility training on the relationship among looking and manual actions, caregiver-child interactions and mastery motivation in toddlers with mild, moderate and severe motor delays.

Based on the power analysis from the preliminary results of the pilot study, we will recruit 72 toddlers with motor delays and further assign them to the mild, moderate or severe motor delays group. The participants in each group will be randomly assigned to either the ROC training program or conventional therapy (Control) program, resulting the following six training groups: the ROCStand(Mild) group (n=12), the ROC-Stand25(Mod) group (n=12), the ROCSit(Sev) group (n=12), Control(Mild) group (n=12), Control(Mod) group (n=12), and Control(Sev) group (n=12). The whole study duration will be 24 weeks, including a 12-week intervention and a 12-week follow-up. All programs will include 120 minutes/per session, 2 sessions/per week. Participants will continue their regular therapy during the whole study. The head-mounted cameras worn by the participants and caregivers will record the visual and manual behaviors for 40 minutes/per week during intervention. Standardized assessments are provided for a total three times, including the time before and after the intervention and in the end of the follow-up phase. Assessments include body function, mobility, psychosocial function, family perception and participation. The findings of this study will provide guidelines for arranging the training environment depending on each child's and family's needs.

Conditions

• Young Children With Motor Disabilities

Interventions

BEHAVIORAL

Ride-On Cars Training with Different Postures

A licensed, independent therapist and caregivers will provide the training program in the public space in the university for a total of 12-week intervention based on ecological and dynamic systems theories. Training will concentrate on building the concept of casual-effect on the control system and car motion, practicing goal-oriented driving (e.g., driving 200 meters and reach for a toy or contact with a person, play hide-and-seek) in certain public spaces, including hallways, convenient stores, garden, museum and upper limb use in functional tasks with driving, facilitating hand use in functional tasks for exploration and applying various motor skills for mobility and socialization in natural play session. Every week's treatment program will preplanned and adjusted by the therapist and the caregivers through discussion and clinical observation of participant's performance in the previous session. Participants will continue their regular therapy during the whole study.

BEHAVIORAL

Conventional Therapy

The other independent OT will be responsible for providing conventional therapy based on the developmental and motor learning theories. The goals are to improve certain motor skills or psychosocial skills based on each participant's current developmental stage. The general propose of the training is to facilitate the developmental scales and improve mobility, socialization and upper limb use in functional tasks.

Sponsors & Collaborators

• Chang Gung Memorial Hospital

  lead OTHER

Principal Investigators

• Hsiang-Han Huang, ScD · Chang Gung University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-10

Primary Completion

2024-11-30

Completion

2025-07-31

Countries

• Taiwan

Study Locations