A Randomized Controlled Trial of ride-on Car Training and Locomotor Experience in Toddlers With Different Motor Delays

Summary

The three purposes of this study are: 1) to compare the effectiveness of the ROC-Stand training on mobility, psychosocial function and social looking with conventional therapy in toddlers with mild and moderate motor disabilities, 2) to compare the effectiveness of ROC-Stand training on body function level and environmental factors with conventional therapy in toddlers with mild and moderate motor disabilities, according to International Classification of Functioning, Disability and Health (ICF) levels, and 3) to determine the effects of ROC-Stand training on the relationship among social looking, caregiver-child interactions and mastery motivation in toddlers with mild and moderate motor disabilities.

Based on the power analysis from the preliminary results of the pilot study, the investigator will recruit 92 toddlers with motor delays and further assign them to either mild or moderate motor delays group. The participants in each group will be randomly assigned to either the ROC-Stand training program or conventional therapy(Control) program, resulting the following four training groups: the ROC-Stand(Mild) group (n=23), the ROC-Stand(Mod) group (n=23), Control(Mild) group (n=23), and Control(Mod) group (n=23). 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. 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. The head-mounted cameras worn by the participants and caregivers will record the social looking and interaction behaviors for one 2-hour session/per week during intervention. Participants will also wear three accelerometers throughout the 2-hour training. Assessments include mobility, socialization, behavioral coding, body function, family perception and participation. The findings of this study will provide us some optimal, alternative ways to enhance locomotor experience depending on each child's and family's needs.

Conditions

• Mobility Limitation

Interventions

BEHAVIORAL

A Ride-on Car with a Standing Posture

The 2-hour training session is composed of two 30-minute driving sessions and two 25-minute natural play sessions, with a 10-minute break. Every week's treatment program will be before planned and adjusted by the therapist and the caregivers through discussion and clinical observation of participant's performance in the previous session. Training will concentrate on building the concept of casual-effect on the switch and car motion, goal-oriented driving in a hospital, and upper limb use in functional tasks with driving and hand use in functional tasks for exploration in natural play session.

BEHAVIORAL

Regular Therapy Program

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. Each participant will have the opportunity to walk on the hallway/public space and interact with the therapist and caregivers depending on his/her motor abilities.

Sponsors & Collaborators

• National Science and Technology Council, Taiwan

  collaborator OTHER_GOV

• Chang Gung Memorial Hospital

  lead OTHER

Principal Investigators

• HsiangHan Huang, ScD · Chang Gung University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

36 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-05

Primary Completion

2022-08-31

Completion

2022-12-31

Countries

• Taiwan

Study Locations