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

NCT03707405 | Completed

• 1 other identifier: 107WFD2610149
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (4)

• Change from Baseline Mobility and Social Function at 12 Weeks

  The Chinese version of Pediatric Evaluation of Disability Inventory (PEDI-C) is a set of tests for children from 8 months to 6 years old. The PEDI-C quantifies self-care, mobility, and social function, and is particularly useful for tracking changes in functional skills. Each domain can be used separately for data analysis. The inter-rater and intra-rater reliabilities of the study reveal excellent agreement of the observations (0.95-0.99), and good concurrent validity with the Functional Independence Measure for Children (Spearman ρ, 0.92-0.99).

  PEDI will be administered on two occasions: before and after the 12-week intervention (T1 & T2).

• Mobility-Driving Performance

  Every week during the intervention phase, the 70-minute driving will be recorded and the most active 30 minutes will be selected for coding. The following behaviors will be coded, including driving categories (independent mobility, assisted mobility, caregiver mobility), visual attention to the switch and stopping categories (independent stop, stops with verbal cues, stops with tactile contacts).

  30 minutes/per week for a total of 12 weeks

• Socialization

  The behaviors of social interactions are obtained during the most active 30 minutes of driving and the most active 10 minutes of the recorded 20-minute natural play, i.e., the first 20 minutes of natural play. From these videotapes, the frequency and duration of the following will be coded: physical contacts, initiation of contact with others, other initiated contacts, facial expressions, vocalizations/gestures and mutual play events (e.g. sharing an object or a toy).

  40 minutes/per week for a total of 12 weeks

• Change from Posttest Mobility and Social Function at 12 Weeks

  The Chinese version of Pediatric Evaluation of Disability Inventory (PEDI-C) is a set of tests for children from 8 months to 6 years old. The PEDI-C quantifies self-care, mobility, and social function, and is particularly useful for tracking changes in functional skills. Each domain can be used separately for data analysis. The inter-rater and intra-rater reliabilities of the study reveal excellent agreement of the observations (0.95-0.99), and good concurrent validity with the Functional Independence Measure for Children (Spearman ρ, 0.92-0.99).

  PEDI will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3).

Secondary Outcomes (13)

• Change from Baseline Sit-to-Stand at 12 Weeks

  This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2).

• Change from Posttest Sit-to-Stand at 12 Weeks

  This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3).

• Change from Baseline Mastery Motivation at 12 Weeks

  This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2).

• Change from Posttest Mastery Motivation at 12 Weeks

  This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3).

• Change from Baseline Developmental Abilities at 12 Weeks

  This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2).

Study Arms (4)

ROC-sit

ACTIVE COMPARATOR

Ride-On Cars with Sitting Posture (ROC-sit) The 2-hour training session is composed of a 70-minute driving session and a 40-to-50-minute natural play session, with a 10-mintue break if necessary. The natural play session can be divided into two 20-to-25 sessions depending on the participant's condition. Training will concentrate on building the concept of casual-effect on the switch and car motion, practicing goal-oriented driving (e.g., driving 200 meters and reach for a toy or contact with a person) in public spaces (e.g., hallways, convenient stores, garden, museum) and upper limb use in functional tasks with driving, facilitating hand use in functional tasks for exploration and applying motor skills for mobility and socialization in natural play session. All the programs will be discussed by the family, the treating therapist and the research team.

Behavioral: Ride-On Cars Training with Different Postures

ROC-sit45 and stand25

ACTIVE COMPARATOR

Ride-On Cars with 45-min Sitting and 25-min Standing Postures (ROC-sit45 and stand25) The training guidelines and time are the same as the ROC-sit group, except for the posture of driving. The 70-minute driving session begins with a 45-minute driving with sitting posture and then transfers to the standing posture for driving 25 minutes.

Behavioral: Ride-On Cars Training with Different Postures

ROC-sit25 and stand45

ACTIVE COMPARATOR

Ride-On Cars with 25-min Sitting and 45-min Standing Postures (ROC-sit25 and stand45) The training guidelines and time are the same as the ROC-sit group, except for the posture of driving. The 70-minute driving session begins with a 25-minute driving with sitting posture and then transfers to the standing posture for driving 45 minutes.

Behavioral: Ride-On Cars Training with Different Postures

ROC-stand

ACTIVE COMPARATOR

Ride-On Cars with Standing Postures (ROC-stand) The training guidelines and time are the same as the ROC-sit group, except for the posture of driving. The 70-minute standing session can be divided into two 30-minute sessions with 10-minute break, depending on the child's condition with the standing posture.

Behavioral: Ride-On Cars Training with Different Postures

Interventions

Ride-On Cars Training with Different Postures BEHAVIORAL

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.

Also known as: Ride-On Cars with 45-min Sitting and 25-min Standing Postures, Ride-On Cars with 25-min Sitting and 45-min Standing Postures, Ride-On Cars with Standing Postures

ROC-sit; ROC-sit25 and stand45; ROC-sit45 and stand25; ROC-stand

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• motor delays that resulted in motor impairments that prevented independent walking (standard deviation (SD) \> 1.5, assessed by the Chinese Child Development Inventory59,60 via a pediatric physician)
• can stand independently for two seconds or to tolerate standing with support for 10 minutes
• can reach objects with either one or two hands
• the height is between 69 to 103 cm and the weight is between 7-18 kg
• parents are able to provide consent for their child's participation in the ROC training programs.

You may not qualify if:

• children with severe sensory impairments such as blindness, deafness
• the height is not between 69 to 103 cm and the weight is not between 7 to 18 kg
• parents/caregivers are not able to make a time commitment for the training phase

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (2)

Chang Gung University

Taoyuan, Taoyuan County, 33302, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan, Taoyuan County, 33302, Taiwan

Location

Related Publications (1)

• Huang HH, Chu YW, Chan AT, Chen CL. A pilot randomised controlled trial of ride-on cars and postural combinations of standing and sitting for mobility and social function in toddlers with motor delays. Disabil Rehabil Assist Technol. 2025 Jan;20(1):53-63. doi: 10.1080/17483107.2023.2299712. Epub 2024 Jan 5.

  PMID: 38180348 DERIVED

MeSH Terms

Interventions

Sitting Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hsiang-Han Huang, ScD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: October 16, 2018
• Study Start: November 15, 2018
• Primary Completion: June 28, 2020
• Study Completion: August 31, 2020
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)