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

NCT02527499 | Completed

• 1 other identifier: CMRPD3E0311
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Children With Mobility Disabilities

Outcome Measures

Primary Outcomes (4)

• Change from baseline in General Mobility and Social Development at 9 weeks and 18 weeks as assessed by the Pediatric Evaluation of Disability Inventory (PEDI)

  PEDI is a set of tests for children from 8 months to 6 years old. The PEDI quantified self-care, mobility, and social functions. The PEDI is especially useful for tracking changes in functional skills.

  Assessment will occur 3 times during the whole study, including the first and last week of the 9-week intervention, and the end of the 9-week follow-up phase.

• Mobility/Driving Performance as assessed by the coding behaviors from the videotaping

  The driving behaviors will be coded from each 10-minute Car Play session: a) amount of time moving/total time, b) frequency, time and duration of parental assistance (physical and/or vocal), c) number of successful "directional driving trials". In each of 10 trials, the child is asked to drive 5 feet to the parent or researcher. He/she is given 30 seconds to complete the distance and make a stop at the goal.

  The driving behaviors will be followed for the duration of implementing the intervention program at the hospital, an expected average of 9 weeks.

• Socialization as assessed by the coding behaviors from the videotaping

  The frequency and duration related to socialization will be coded during the whole 20-minute Play, including 10-minute Natural Play and 10-minute Car Play: physical contacts, initiation of contact with others, other initiated contacts, facial expressions, vocalizations/gestures and mutual play events (ex. sharing a toy).

  The socialization behaviors will be followed for the duration of implementing the intervention program at the hospital, an expected average of 9 weeks.

• Physical activity as assessed by the amount of counts from the wrist accelerometers

  Each week the participant will wear the accelerometers on both wrists during the 1 hour videotaping session, including 30-minute driving and 30-minute natural play. The accelerometers code the physical activity for driving and playing.

  The physical activity will be recorded for the duration of implementing the intervention program at the hospital, an expected average of 9 weeks.

Secondary Outcomes (5)

• Change from baseline in General Development at 9 weeks and 18 weeks as assessed by The Bayley Scales of Development

  It will be administered a total of 3 times during the whole study, including the beginning and end of the 9-week intervention, and the end of the 9-week follow up.

• Change from baseline in General Development at 9 weeks and 18 weeks as assessed by the Goal Attainment Scale (GAS)

  It will be administered a total of 3 times during the whole study, including the beginning and end of the 9-week intervention, and the end of the 9-week follow up.

• Change from baseline in General Development at 9 weeks and 18 weeks as assessed by the Affordances in the Home Environment for Motor Development (AHEMD)

  It will be administered a total of 3 times during the whole study, including the beginning and end of the 9-week intervention, and the end of the 9-week follow up.

• Change from baseline in Parents' Perceptions at 9 weeks and 18 weeks as assessed by Parenting Stress Index (PSI)

  It will be administered a total of 3 times during the whole study, including the beginning and end of the 9-week intervention, and the end of the 9-week follow up.

• The Revised Dimensions of Mastery Questionnaire (DMQ 18) - Chinese version

  it will be administered a total of 3 times during the whole study, including the beginning and end of the 9-week intervention, and the end of the 9-week follow up.

Study Arms (3)

ROCBT group

EXPERIMENTAL

The participant's performance is indicative of the extent to which early power mobility training is feasible for 1 to 3 years old and diagnosed as motor delay (\>1.5 sd). Parents/caregivers and occupational therapists will be responsible for Ride-On Cars with Bimanual Training Program (ROCBT) group.

Behavioral: Ride-On Cars with Bimanual Training Program (ROCBT)

Early Mobility Training group

ACTIVE COMPARATOR

The participant's performance is indicative of the extent to which early power mobility training is feasible for 1 to 3 years old and diagnosed as motor delay (\>1.5 sd). Parents/caregivers and occupational therapists will be responsible for Early Mobility Training Program group.

Behavioral: Early Mobility Training Program

Regular Therapy group

ACTIVE COMPARATOR

The participant's performance is indicative of the extent to which early power mobility training is feasible for 1 to 3 years old and diagnosed as motor delay (\>1.5 sd). Parents/caregivers and occupational therapists will be responsible for Regular Therapy Program group.

Behavioral: Regular Therapy Program

Interventions

Ride-On Cars with Bimanual Training Program (ROCBT) BEHAVIORAL

The car driving training includes 2 phases: I-car exploration and II-prompted driving. Participants can learn how to move and stop the car in the car exploration phase. Through prompted driving in phase II, they can use the car as a mean to explore environments (e.g., to the elevator, to different stores) and contact with people (e.g., drive to the caregiver and get the toy). Bimanual training involves activities which include perceptual motor tasks (e.g., smear both hands with color), holding and manipulative tasks (e.g., cutting toy vegetables or fruits), posture and balance (e.g., pull a cart), and self-care and activities of daily living (e.g., drinking water from a cup with two handles).

ROCBT group

Early Mobility Training Program BEHAVIORAL

Most of the guidelines are similar with ROCBT, except for the bimanual training. The therapist and family will merely focus on independent mobility training and improving socialization. The training time and period is the same as ROCBT.

Early Mobility Training group

Regular Therapy Program BEHAVIORAL

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 1 hour/per session, 1 session/per week during the 9-week intervention phase.

Regular Therapy group

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• motor delays (sd\>1.5) resulting in motor impairments that prevented functional independent mobility, such as rolling, crawling, walking;
• aged between 12 months to 36 months old
• able to tolerate sitting with support for 30 minutes
• able to reach the objects with either one or two hands
• consent of the parents to agree to the testing procedures and participate in the training program at the hospital.

You may not qualify if:

• children with severe sensory impairments such as blindness, deafness
• parents/caregivers are not able to make a time commitment for the training phase

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 33302, Taiwan

Location

Related Publications (1)

• Huang HH, Chen YM, Huang HW, Shih MK, Hsieh YH, Chen CL. Modified Ride-On Cars and Young Children with Disabilities: Effects of Combining Mobility and Social Training. Front Pediatr. 2018 Jan 15;5:299. doi: 10.3389/fped.2017.00299. eCollection 2017.

  PMID: 29387682 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: August 19, 2015
• Study Start: July 15, 2015
• Primary Completion: December 31, 2016
• Study Completion: March 31, 2017
• Last Updated: July 8, 2020

Record last verified: 2017-01

Locations

TW (1)