Does Dosage Matter: Ride-on Cars to Enhance Social-mobility Function and Motivation in Toddlers With Motor Disabilities

Summary

Modified ride-on toy cars (ROCs) have been viewed as one Maker Movement and become an innovative, alternative option to enhance independent mobility and socialization in young children with disabilities in the recent years. To increase the applicability of this novel intervention, this study proposes a modified ROC-training program with a less-intensive dose which may be an effective and a more feasible protocol for clinical therapists and caregivers to implement.

The three purposes of this study are: 1) to compare the effectiveness of different dosages of ROC training with a standing posture on social-mobility function, mastery motivation and physical activity in toddlers with motor disabilities; 2) to determine the optimal dosage of ROC training with a standing posture that is needed to enhance social-mobility function, mastery motivation and physical activity in toddlers with motor disabilities; and 3) to examine the effects of different dosages of ROC training with a standing posture on the ICF functioning levels, family perceptions and participation.

Based on the power analysis from the preliminary results of our RCT study, the investigator will recruit 45 children with disabilities who are between 1 to 3 years old and diagnosed as motor delay. They will be randomly assigned to one of the following three groups: a 48-hour ROC training program with a standing posture (ROC-48) (n=15), a 24-hour ROC training program with a standing posture (ROC-24) (n=15), and a regular therapy program without additional training (n=15). The whole study duration will be 24 weeks, including 12-week intervention and 12-week follow-up. The ROC-48 and ROC-24 programs will include 2 sessions/per week, each session for 1 hour (ROC-24) or 2 hours (ROC-48) training. All 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. Assessments include social mobility, mastery motivation, behavioral coding, body function, family perception and participation. The use of modified toy cars with different dosages will provide the family and therapists a set of novel, alternative ways to increase family participation and facilitate development in toddlers with disabilities, depending on children's and family's needs.

Conditions

• Mobility Limitation

Interventions

BEHAVIORAL

A 48-hour ROC training program 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

A 24-hour ROC training program with a standing posture

The 1-hour training session is composed of a 30-to-35-minute car play and a 25-minute natural play. 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

A regular therapy program without receiving any ROC training

The regular therapy group will be an active control group without receiving any additional training. The training dosage will be their own therapy, including occupational, physical and speech therapy. They will continue their regular therapy, including physical, occupational and speech therapy. The general propose of the training is to improve the developmental scales, 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

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

2022-05-05

Completion

2022-07-29

Countries

• Taiwan

Study Locations