NCT02527499

The Effects of Combining Modified ride-on Cars With Bimanual Training on Enhancing Mobility, Socialization, Motor Function and Participation in Toddlers With Disabilities

Completed NA Last updated 8 July 2020

What this trial tests

NA trial testing Ride-On Cars with Bimanual Training Program (ROCBT) in Children With Mobility Disabilities in 29 participants. Completed in 31 March 2017.

Timeline

15 July 2015

Primary endpoint
31 December 2016

31 March 2017

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	29
Start date	15 July 2015
Primary completion	31 December 2016
Estimated completion	31 March 2017
Sites	1 location across Taiwan

Drugs / interventions tested

• Ride-On Cars with Bimanual Training Program (ROCBT)
• Early Mobility Training Program
• Regular Therapy Program

Conditions studied

• Children With Mobility Disabilities — all drugs for Children With Mobility Disabilities →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 12 Months to 36 Months, any sex, with Children With Mobility Disabilities. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The four purposes of this study are: 1) to examine the feasibility of combining modified ride-on cars with bimanual training (ROCBT) on mobility, socialization and motor function in toddlers with disabilities; 2) to quantify whether toddlers with disabilities are able to have more manual explorations and social interactions with ROCBT through observation and wrist-worn accelerometers; 3) to determine the critical factors of using the modified ride-on toy car on family perceptions and participation.

Independent mobility is believed to be essential for perceptual-motor, cognition, language and social skill development. It is important to increase independent mobility in toddlers with disabilities and further enhance their development, especially socialization. Assistive and power mobility devices allow toddlers with disabilities to move independently within their environment and may increase the opportunities to explore and interact with people and environment. However, issues to consider before prescribing an assistive device include factors such as age, accessibly to community environments, cost, and social acceptance of the device and the adaptability of the device to growth. To address these limitations and meet toddlers' needs, the concept of using modified ride-on toy cars in therapy becomes a novel application. Study has demonstrated the use of toy cars enhanced a child's motivation, socialization and family participation. This study is further to combine the use of customized, modified ride-on toy cars with bimanual training, to enhance the independent mobility, manual exploration and socialization through low-cost, family-centered approach. It will also improve family's understanding of children's capabilities, which improve their development.

Investigators will recruit 75 children with who are between 1 to 3 years old and diagnosed as motor delay (\>1.5 sd). They will be randomly assigned to one of the following three groups: ROCBT treatment group, early mobility training group and regular therapy group. The whole study duration will be 18 weeks, including 9-week intervention and 9-week follow-up; the total amount of treatment will be equal for two 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 ROCBT and early mobility training 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 wearing wrist-worn accelerometers. 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 behavior coding from the videotapes and accelerometers. The findings of this study will help to understand the feasibility and effectiveness of combining the low-tech modified ride-on cars with bimanual training on advancing children's mobility and socialization. They can be used in the clinic or school and are a low cost alternative or addition to other mobility devices. They may provide a novel therapeutic tool to improve mobility, socialization, family participation and development.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Modified Ride-On Cars and Young Children with Disabilities: Effects of Combining Mobility and Social Training.
   Huang HH, Chen YM, Huang HW, Shih MK, et al · · 2017 · cited 22× · PMID 29387682 · DOI 10.3389/fped.2017.00299