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

Summary

The three purposes of this study are: 1) to compare the effects on looking behaviors, visual fixation and social interaction through the use of a head- mounted, eye-tracker in toddlers with motor disabilities after receiving different intensity levels of ROC-Stand training; 2) to compare short-term and long-term outcomes in terms of body function, activity and participation across the ICF framework, family perceptions and participation; and 3) to identify factors that predict individual differences in outcomes for toddlers with motor delays with the two dosing protocols. Based on the power analysis from the pilot study, the investigators will recruit 30 toddlers with motor delays and further randomly assign the participants to the 3 groups with the same total amount of 48-hour training, including 2 ROC-Stand groups and 1 conventional therapy group, i.e., an intensity level of 2-hour session of ROC-Stand training (ROC-Stand(2-hr)) (n=10), an intensity level of 1-hour session of ROC-Stand training (ROC-Stand(1-hr)) (n=10), and an intensity level of 1-hour session of conventional therapy (Control(1-hr)) (n=10). The training frequency for the 3 groups is 2 sessions/per week. The whole study duration will be 1 year. The head-mounted cameras worn by the participants will record the visual and interactive behaviors for 20 minutes/per week during intervention. Standardized assessments are provided for a total 4 times, including the time before training (T1), 3 months following initiation of training (T2), 6 months following initiation of training (T3), and the end of a year following initiation of training (T4). Assessments include body function, activity and participation across the ICF domains, family perception and participation. The findings of this study will provide guidelines for adjusting the dosage parameters of early powered mobility depending on each child's and family's needs.

Conditions

• Young Children With Motor Disabilities

Interventions

BEHAVIORAL

Ride-On Car Training in a standing posture with a 2-hour session

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

Ride-On Car Training in a standing posture with a 1-hour session

A licensed, independent therapist and caregivers will provide the training program in the public space in the university for a total of 24-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 the participant's performance in the previous session. Participants will continue their regular therapy during the whole study.

BEHAVIORAL

Conventional Therapy with a 1-hour session

The other independent OT will be responsible for providing conventional therapy in the same location as the ROC-Stand training for a total of 24-week intervention 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 purpose 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

2023-08-30

Primary Completion

2025-11-30

Completion

2026-07-31

Countries

• Taiwan

Study Locations