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Compare the Effectiveness of Modified Toy Cars Training With Various Intensity of Postural Combinations

NCT03707405 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-03-14

No results posted yet for this study

Summary

The three purposes of this study are: 1) to determine the feasibility of applying two types of postural combinations for the ride-on car (ROC) use; 2) to compare the effectiveness of ROC training with various intensity of postural combinations on mobility, socialization and energy expenditure in toddlers with disabilities; and 3) to examine the effects of using the different modes of ROC training (different intensity of postural combinations) on the ICF functioning levels, family perceptions and participation. Modified ride-on toy cars (ROCs) as a type of PMDs have become an innovative, alternative option to enhance independent mobility and socialization in young children with disabilities. Evidence suggested that dose-response effect and energy expenditure of the two postures used for training may result in the observed differences. Therefore, this study is further to examine the effectiveness of ROC training with various intensity of postural combinations on independent mobility, socialization, motivation, physical activity and overall development through low-cost, family-centered approach.

Based on the power analysis from the preliminary results, the investigators will recruit 92 children with disabilities 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 four groups: ROC-sit group (n=23), ROC-stand group (n=23), ROC training with 45-min sitting and 25-min standing (n=23), and the ROC training group with 25-min sitting and 45-min standing (n=23). 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 the four groups. 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. All programs will include 120 minutes/per session, 2 sessions/per week. The research team will provide 90-min behavioral videotaping once/per week and let participants wear three accelerometers throughout the 2-hour training. Assessments include mobility, socialization, behavioral coding, family perception and participation. The findings of this study will provide a novel application of ROC training with various intensity of postural combinations on advancing children's mobility, socialization, development and family participation.

Conditions

  • Young Children With Motor Disabilities

Interventions

BEHAVIORAL

Ride-On Cars Training with Different Postures

All programs will include 120 minutes/per session, 2 sessions/per week. All participants will continue their regular therapy during the whole study. The treatment strategy of ROC training with different postures will be based on the exploratory learning which focuses on providing opportunities to the participants to explore environmental properties with various motor patterns during the intervention.

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
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2020-06-28
Completion
2020-08-31

Countries

  • Taiwan

Study Locations

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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 NCT03707405 on ClinicalTrials.gov