Advancing Mobility and Socialization in Toddlers With Disabilities: Modified Toy Cars Training With Different Postures

Summary

The three purposes of this study are: 1) to examine the feasibility and effects of ride-on car training with two different postures on mobility and socialization in toddlers with disabilities; 2) to quantify whether toddlers with disabilities are able to have more exploratory behaviors and social interactions with ride-on car training through observation and wrist-worn accelerators; 3) to determine the critical factors of using the different modes of modified ride-on toy car on family perceptions and participation.

The concept of using modified ride-on toy cars (ROC) in therapy has became a novel application in recent years. This study is further to examine the effects of ride-on toy car training with two different postures, i.e., sitting and standing , on independent mobility, exploration and socialization through low-cost, family-centered approach. It will also improve family's understanding of children's capabilities, which improves their development. Based on the power analysis from the preliminary results of investigator group study, investigators will recruit 60 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: ROC-Sit group, ROC-Stand group and regular therapy group. The whole study duration will be 24 weeks, including 12-week intervention and 12-week follow-up; the total amount of treatment will be equal for three groups. Standardized assessments are provided for a total of three times during the study, including the time before and after the intervention and in the end of the follow-up phase. The ROC-Sit and ROC-Stand programs will be administered by the therapist and include 120 minutes/per session, 2 sessions/per week. The research team will visit the hospital once/per week to provide 60 minutes videotaping and let participants wear wrist-worn accelerators. The regular therapy group will continue their regular therapy without any additional car driving training. The research team will visit them once/per week for the assessments. The assessments include standardized measurements and behavioral coding from the videotapes and accelerators. The findings of this study will provide a novel therapeutic tool (i.e., combining the low-tech modified ride-on cars with different postures) on advancing children's mobility, socialization, family participation and development.

Conditions

• Children With Mobility Disabilities

Interventions

BEHAVIORAL

Ride-On Cars with Standing Posture (ROC-Stand)

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

Ride-On Cars with Standing Postures (ROC-Sit)

Most of the guidelines are similar with ROC-Stand, except for the posture of driving. The training time and period is the same as ROC-Stand. The two 30-minute driving sessions can also be divided into 4 times of 15-minute sessions, depending on the child's standing ability with supported condition.

BEHAVIORAL

Regular Therapy Program

The research team will ask caregivers to identify goals (before intervention), and measure progress using goal-attainment scaling (GAS). The regular therapy group will continue the regular therapy, including physical, occupational and speech therapy. In addition, they will receive training program in a hospital for 2 hours/per session, 2 sessions/per week for a total of 12-week intervention. The participants will also experience the two 30-minute car driving sessions during the whole 2-hour training. The difference between the regular therapy group and the two ROC groups is the experience of car driving is controlled by the therapist, i.e. passive locomotion. The general propose of the training is to improve the developmental scales, mobility, socialization and upper limb use in functional tasks. The research team will videotape the child's natural play and driving performance for 1 hour/per session, 1 session/per week during the 12-week intervention phase.

Sponsors & Collaborators

• 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

2015-11-05

Primary Completion

2019-07-31

Completion

2019-10-31

Countries

• Taiwan

Study Locations