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

NCT02505061 | Completed

• 1 other identifier: NSC102-2314-B-182-002
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 occurred 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 were 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 were 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 were 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 were followed for the duration of implementing the intervention program at the hospital, an expected average of 9 weeks.

Secondary Outcomes (2)

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

  It was 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 was 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 (1)

Program

EXPERIMENTAL

The participant"s performance is indicative of the extent to which early power mobility training is feasible for both young infants and up to 3-year-old child with mobility Disabilities.Parents/caregivers and occupational therapists will be responsible for theHospital-based Program and Regular Therapy Program service respectively

Behavioral: Hospital-based Program; Behavioral: Regular Therapy Program

Interventions

Hospital-based Program BEHAVIORAL

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.

Program

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 20 minutes/per session, 1 session/per week during the 9-week intervention phase

Program

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 their own house or 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 22, 2015
• Study Start: August 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 22, 2015

Record last verified: 2015-06