The Use of Modified ride-on Cars to Advance Mobility and Socialization in Young Children With Disabilities

NCT02505061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-07-22

No results posted yet for this study

Summary

The four purposes of this study are: 1) to examine the feasibility of providing children with disabilities to explore the environment with a modified ride-on car; 2) to quantify whether children with disabilities are able to have more social interactions with a ride-on car; 3) to examine the progression of socialization during the intervention and follow-up phases to determine which factors might influence the learning curve; 4) to compare the effectiveness of using the modified toy cars through the hospital-based program and regular therapy program after intervention and follow-up phases to determine the critical factors on increasing independent mobility and socialization, including motivation, treatment executor, treatment environment and play programs. It can provide guidelines for the future intervention.

Independent mobility is believed to be essential for perceptual-motor, cognition, language and social skill development. It is important to increase the independent mobility in children with disabilities and further enhance their development, especially motor and socialization. Assistive and power mobility devices allow children 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, social acceptance of the device and the adaptability of the device to growth. This study is to use the customized, modified ride-on toy cars, to enhance the independent mobility, 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 60 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 two groups: hospital-based program 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. The hospital-based program will be administered by the therapist and include 120 minutes/per session, 2 sessions/per week. In addition, the research team will visit the hospital once/per week to provide assessments. 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 behavior coding from the videotapes and the clinical assessments. The findings of this study will help to understand the feasibility and effectiveness of using the low-tech modified toy cars on advancing children's mobility and socialization. They can be used in the clinics and are a low cost alternative or addition to other mobility devices. They may provide a novel therapeutic tool to improve mobility, socialization and development.

Conditions

  • Children With Mobility Disabilities

Interventions

BEHAVIORAL

Hospital-based Program

The research team will discuss with the clinical therapists who will provide training program in a hospital for 120 minutes/per session, 2 sessions/per week for a total of 9-week intervention. In addition, the research team will videotape the child"s natural play and driving performance at the hospital for 20 minutes/per session, 1 session/per week during the 9-week intervention phase. The treatment program of the two sessions will be preplanned and adjusted by the occupational therapist through clinical observation of participant's performance in the previous session. Training will still concentrate on building the concept of casual-effect on the switch and car motion, goal-oriented driving (e.g., driving 200 meters and reach for a toy or contact with a person), and upper limb use in functional tasks with driving in a hospital,discussed by the family, the treating therapist and the research team.

BEHAVIORAL

Regular Therapy Program

The regular therapy group will continue the 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. The research team will videotape the child"s natural play and driving performance at the hospital for 20 minutes/per session, 1 session/per week during the 9-week intervention phase

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-07-31
Completion
2014-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02505061 on ClinicalTrials.gov