The Use of Modified ride-on Cars to Advance Mobility and Socialization in Young Children With Disabilities
Condition: Children With Mobility Disabilities
Study type: Interventional

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.
    

Detailed description: 
      Children with mobility disabilities have more limited opportunities to explore their
      environment; therefore, they are considered to be at risk of secondary impairments, such as
      cognitive, spatial-perceptual, and social-emotional delay. Independent mobility is believed
      to be essential for perceptual-motor and social skills development. Self-produced locomotion
      is an organizer of psychological changes in typically developing infants/children, especially
      developmental changes in perceptions, social understanding, spatial cognitive, and emotions.
      Power mobility devices provide the potential for children with disabilities to move more
      independently and increase their exploration and interaction with the social and physical
      environment. Through the exploration, infants can detect the object and individual"s
      information that relates size, orientation, shape, substance to their perceptual and movement
      capabilities and interpersonal relationships. Logically, starting powered mobility as part of
      a comprehensive Early Intervention (EI) program within the first year of life should not only
      provide mobility but also reduce secondary impairments for children with disabilities.
      Although of increasing interest, there is very little empirical evidence of the effects or
      even feasibility of early power mobility training on development, particularly for mobility
      and socialization. A hallmark of daily life for the typically developing infants and toddlers
      is hours of mobility nested within exploration, socialization and object play in the home and
      community.Pediatric rehabilitation, through training and assistive technology (AT), seeks to
      provide children with disabilities with this same level of mobility, exploration and
      socialization. There are many basic barriers to achieving this high standard and no single AT
      or combination of AT can currently provide the level of mobility that children, families and
      therapists desire. For example, certain characteristics of the most common commercial
      pediatric power wheelchairs limit their use in the home and community spaces such as
      playgrounds. These limitations include price (e.g., typically $5000), size and weight (e.g.,
      typically >150 lbs), transportation requirements (e.g., van or truck), maintenance and
      aesthetics and social acceptance. The most obvious limitation for including power mobility in
      EI programs is the complete lack of readily available power chairs for children younger than
      2-3 years of age, the period when mobility is rapidly developing for typically developing
      children. Experimental power mobility devices have the potential to address some of these
      limitations such as size, weight and infant use. Unfortunately these are likely years from
      commercial availability. Furthermore, power wheelchairs have historically been designed to
      address a limited set of goals related to mobility with minimal consideration of
      socialization. Investigators believe there is a need for readily available mobility options
      for immediate use by very young children and their families that address some of the above
      limitations while expanding the role of power devices past simply mobility and into
      socialization. The general purpose of this study is to determine the feasibility of using a
      "ride-on toy car" as an early option for power mobility. Furthermore, this study will examine
      the effects of using a toy car to advance mobility and socialization in the early
      development. The use of modified ride-on toy cars may provide a readily available, convenient
      and fun way for families, therapists and early educators to help young children improve their
      mobility starting within the first years of life. There are four strengths of using ride-on
      toy cars for mobility. First, the cost is comparable or less than most mobility devices.
      Second, most are relatively lightweight, small and easily transported in contrast to power
      chairs. Third, the child-friendly, colorful toy designs are more acceptable to adults and
      children and likely seen as simply a toy. This may be an important aspect for clinicians
      wanting to start early power mobility training with families hesitant to discuss powered
      chair options. Fourth, because toy cars are simple electromachanical devices, they can be
      modified quickly and easily to match the child's current and/or future abilities and goals.
      Ride-on cars provide fun and mobility for typically developing children and have serious
      potential to be a power mobility option for children with disabilities. Investigators have
      recently published a technical report outing the basic components and exemplar modifications.
      Our pilot study has also shown positive effects on increased socialization in a 2-year old
      child with severe cerebral palsy. No studies have been published on the effectiveness or even
      the feasibility of including these cars with any pediatric population. Thus basic questions
      such as sitting tolerance, basic driving ability and interest in using the car for
      socialization have not been addressed prior to wide spread clinical use. The long term
      effects of using this mobility device on mobility and socialization also remain a question
      for the researchers and clinicians. In addition, little is known about the learning curve of
      using the power mobility device to improve mobility and socialization, e.g., at what point in
      time (maximal) effects are reached. Up to now, most of the studies have focused on the end
      results of increased amount of independent mobility in daily life. It is still unknown
      whether optimal (maximal) effects are being reached at all and which factors (e.g., training
      environment, training executor) might influence the learning curve as well as the retention
      of treatment effects in the long term. In the study by Tieman et al. (2004), they suggested
      that therapists should examine children's performances in the settings that are important to
      their daily life. Examining performance in everyday settings enables the therapists not only
      to observe the child's ability, but also to assess environmental features that either
      facilitate or hinder mobility. Our study will focus on providing intervention and exploratory
      assessments in the home or a clinical setting. This information is essential for making
      future decisions on whether interventions should focus on the child"s motor ability in a
      therapeutic environment from the therapist's perspective, or adaptation of the natural
      environment for the caregiver's application. In this study, investigators will modify ride-on
      toy cars for children with disabilities for use in the clinical settings as part of a 18-week
      power mobility training program. Investigators focus on four basic questions. Specifically,
      can investigators: 1) select and modify toy cars such that children with motor impairments
      enjoy sitting and driving, 2) select a set of dependent measures that quantify whether the
      children increase their independent mobility and socialization; 3) determine the factors that
      influence the learning curve of independent mobility and socialization during intervention
      and follow-up phases; 4) conduct a hospital-based training program that results in a high
      level of fun for the child and compliance by the family and therapists. If our results are
      generally positive and show significant differences between different programs, then future
      randomized controlled trial studies could further quantify the effectiveness and the
      feasibility with different treatment intensity and various pediatric populations.

      Evidence supported that independent mobility might improve different skills for children with
      mobility impairments, including spatial awareness skills, eye-hand coordination, visual
      perceptual skills, spontaneous vocalizations, initiation of contact with others,motivation to
      explore and an increased ability to interact meaningfully with peers. Although the mobility
      devices are considered to be used to compensate for disabilities causing difficulties with
      the accomplishment of daily activities and social roles, the current standard of clinical
      practice in the United States for power wheelchair training is that children must demonstrate
      certain prerequisite abilities before they are eligible. As a result, power mobility
      training, based on readiness, if offered clinically to children between 2 and 6 years old,
      with 3 years being the average age of the youngest child being recommended for a power
      wheelchair.However, several studies have demonstrated that early power mobility training is
      feasible, even for the children who may be categorized as in a "not-ready" group based on
      their age, motor or cognitive abilities. These children had various types of disabilities
      which limited their self produced locomotion. Most of them were younger than 3 years of age
      and the youngest one was only 7-month-old. The early power mobility training allowed these
      young children with mobility impairments move independently and have positive impacts on
      overall development. The investigators reported increased vocalizations, increased arm and
      hand movements, greater motivation to explore,increased self-confidence and curiosity and
      positive effects on family life in these children. Power mobility devices can not only be
      designed to compensate children's impairments for independent mobility, but also be used as a
      novel, training device to address socialization, body functions, activity and participation
      goals. Combined with a family centered (e.g., coaching of parents), functional approach which
      aims to promote better functioning in the context of daily life settings (e.g., home
      environment), early power mobility training can help to enhance development and improve
      social participation in children's daily life. Current power wheelchairs have limitations
      that limit their functional use in the community. These include their size, weight, cost,
      accessibility, ease of transportation, maintenance requirements, adaptability to the body
      growth and social acceptance. Experimental devices have the potential to address some
      limitations such as size, weight and cost but may be years from commercial availability.
      Providing a new option of device for early power mobility which addresses these environmental
      limitations is necessary. Furthermore, this device can also be used to focus on the three ICF
      levels as a training tool. For example, our technique report of modifying ride-on toy cars as
      power mobility devices introduces an alternative way to provide early power mobility
      training. Compared to traditional pediatric power wheelchairs, the strengths of modified toy
      cars include less cost, more accessibility to community environments, better aesthetic and
      adjustability. Moreover, a modified toy car is unlike a powered wheelchairs which is a
      medical device and typically focuses on activity and participation levels of ICF. Various
      permanent and temporary modifications of a toy car allow clinicians to address one or more
      ICF levels. For example, more trunk support may help a child to reach the steering wheel and
      grasp toys during car movement to address an ICF activity goal. By lessening the trunk
      support modifications in combination with a simple steering system (e.g., a push-button
      switch), clinicians can provide the child with a more challenging, dynamic postural control
      during driving to address an ICF body functions and structure goal. The child-friendly frame
      of the toy car can motivate a child's exploratory behaviors and may have positive impacts on
      family's and/or other people's perceptions of a child's capabilities. These strengths of a
      ride on toy car make it become the appropriate candidate for the family and therapists to
      improve early independent mobility and socialization for children with mobility disabilities.

      The specific aims 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 to determine which factors might influence the
      learning curve during intervention and follow-up phases; 4) to compare the effectiveness of
      using the modified toy cars through the hospital-based program and regular therapy program to
      determine the critical factors on increasing independent mobility and socialization after
      intervention and follow-up phases, including motivation, treatment executor, treatment
      environment and play programs. Through the comparison of Car Play (i.e., play with the use of
      toy cars) and Natural Play (i.e., play without the use of toy cars), investigators
      hypothesize that children with disabilities are able to learn how to drive the modified toy
      cars in the hospital-based group. They will have increased socialization (i.e.,self-initiated
      contacts, vocalizations, positive facial expressions) when driving the cars than the regular
      therapy program, i.e., control group.

      Study Design: A pretest-posttest control group design was applied. Two groups were involved
      in this project: hospital based program, and regular therapy program. The participants were
      randomly assigned to one of the two groups by using the well-sealed, opaque envelopes when
      they are recruited in the study. Once the participants were recruited in the study, the
      research team modified a toy car based on each participant's capabilities during this
      pre-intervention phase (the first two or three weeks before intervention starts), e.g., seat
      and steering wheel modifications. The study duration for each participant was 18 weeks,
      including 9-week intervention and 9-week follow-up.

      Participantsin the study were 60 infants or preschool children ages 12 months to 36 months
      with motor delays (sd > 1.5). The age group of infants/preschool children was selected based
      on the previous studies on early power mobility training in infants and preschool children.
      Power mobility training was typically offered to children between two and six years of age,
      with three years being the average age of the youngest child being recommended for a powered
      chair. However, studies showed that early power mobility training was feasible for
      7-month-old infants and 18-month-old children with mobility disabilities.

      Recruitment: The children were recruited from self-referrals, health care practitioners, or
      the hospitals in Taipei and Taoyuan, Taiwan where children with motor delays (>1.5 sd) were
      receiving outpatient rehabilitation. The research team initially posted flyers describing the
      study at clinical settings and contacted the therapists in the clinical settings to introduce
      the goals,criteria and general procedure of the study. Parents/guardians obtained information
      about the study through the flyers and their therapists. Parents/guardians, who were
      interested and whose children met the criteria of diagnosis, age, capability determined by
      the doctor and their therapists, were given contact information for the investigator. After
      receiving contact information, the research team contacted the parents/guardian and/or
      therapists for scheduling a date of further testing by the research team at the hospital.
      When the research team contacted the parents, study was explained and parents received a
      letter detailing the procedure and given an opportunity to ask questions. Parents/guardians
      signed this informed consent form at the time of the first visit.

      Procedure: Before the pre-intervention assessments, the research team modified the car's seat
      and acceleration to the hand switch-driven, which allowed the car to be drivable for the
      child who met the inclusion criteria. Each child had a customized ride-on toy car in a
      hospital. After modifications, they received pre-intervention assessments, including
      behavioral videotaping and developmental assessments. The developmental assessments occurred
      at the first and last week of the 9-week intervention, and the end of the 9-week follow-up
      phase. A therapist who did not involve in the intervention and was blinded to the study
      purpose completed all the developmental tests. The driving and socialization behaviors were
      videotaped by the research team for 20 minutes/per session, one session/per week before,
      during and after the intervention phase at the child house or a hospital. All videotapes were
      coded by two independent coders, who were undergraduate students. Prior to making their
      ratings, the coder was instructed as to coding procedures by the PI, but he/she was not
      informed about the group assignment and the purpose of the study. Cohen's kappa coefficient
      was calculated between the two independent raters to establish good reliability before formal
      coding.

      Intervention: Parents/caregivers and occupational therapists were responsible for the
      hospital-based rehabilitation service. For the hospital-based program, the research team
      discussed with the clinical therapists who provided 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 videotaped 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 was pre-planned and adjusted by the occupational
      therapist through clinical observation of participant's performance in the previous session.
      Training concentrated 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.

      Regular Therapy Program: The regular therapy group continued the regular therapy, including
      physical, occupational and speech therapy. The general propose of the training was to improve
      the developmental scales, mobility, socialization and upper limb use in functional tasks. The
      research team videotaped 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.

      Follow-up: This period focused on the 9 weeks follow-up after receiving a treatment program.
      No treatment program was delivered to the participants. The research team still videotaped
      the child's natural play and driving performance at the hospital for 20 minutes/per session,
      1 session/per week during the 9-week follow-up phase.

      Instrument and Procedure: Each participant received pre-intervention assessments, including
      behavioral videotaping and developmental assessments. Behavioral coding involved the
      mobility/driving performance during the 10-minute Car Play and socialization during the whole
      20-minute Play (i.e., 10-minute Natural Play and 10-minute Car Play). The developmental
      assessments occurred at the first and last week of 9-week intervention, and the end of the
      9-week follow-up phase, including the Pediatric Evaluation of Disability Inventory (PEDI),
      the Bayley Scales of Development, and Parenting Stress Index (PSI). Necessary materials
      include two video cameras, a parent log and a customized ride-on car.

      Data Reduction and Analysis: All videotapes will be coded by two independent coders, who are
      undergraduate students. Prior to making their ratings, the coder is instructed as to coding
      procedures, but he/she is not informed about the group assignment and the purpose of the
      study.

      Mobility Measures: The following measures were obtained via video coding the 10-minute Car
      Play during pre-intervention, intervention and post-intervention phases to determine the
      feasibility of learning to drive the car:

        1. Driving Categories (time in seconds)

           a. Independent Mobility: When the child independently drives the car preceded by an
           independent switch contact without an adult's assistance. b. Assisted Mobility: When an
           adult puts the child"s hand on the switch but he independently pushes the switch to
           begin driving. c. Caregiver Mobility: When the child drove with an adult"s hand directly
           on top of his hand.

        2. Visual Attention to Switch: The frequency (number of times) that the child looked at the
           switch during the 10-minute driving.

        3. Stopping Categories (number of times divided by total times goal was presented) a.
           Independent Stop: When the child independently moves his hand off the switch and makes
           the car stop within one car length of the goal location. b. Stops with Verbal Cues: When
           the child moves his hand off the switch as the car arrives the goal only after verbal
           cues given from an adult. c. Stops with Tactile Contacts: When the child moves his hand
           off the switch as the car arrives the goal only after tactile cues (e.g., touching his
           hand or moving his hand off the switch) given from an adult

      Socialization Measures: To examine the impact of independent mobility on the socialization
      during the 10- minute Natural Play and 10-minute Car Play, the following measures will be
      obtained via coding video footage during pre-intervention, intervention and
      post-intervention:

        1. Reaching for toy/person: The frequency (number of times) that the child initially
           extends arms to the play toy/interacting person.

        2. Initiation of contact with others: peer-directed or adult-directed: Target
           child-initiated contacts with others are counted whenever two conditions are met: (a)
           the target child initiates the contact with another individual without any observable
           prompting or initiating behavior on the part of another person and (b) the target child
           independently vocalizes (with either comprehensible words or other vocalizations,
           including shouting,laughing, grunting, etc.) or physically points to, touches, or
           indicates that he or she wants something from another individual. Target child-initiated
           contacts and vocalizations are divided into two categories: (i) peer-directed and (ii)
           adult-directed.

        3. Other initiated contacts: contact by peers or by adults: Peer-initiated contacts are
           defined as any child initiating any type of contact with the target child (e.g., talking
           to the child, touching the child or a mobility device the child is using, giving a toy
           or item to the child,taking a toy or item away from the child). Adult-initiated contacts
           with the target child are: (a) carrying, moving, or otherwise touching the child or the
           device in which the child is seated (e.g., swing, wheelchair, toy car); (b) taking a toy
           or item away from the child

        4. Facial Expression: The frequency (number of times) of both positive and negative facial
           expressions appeared during interaction. Positive was determined to include smiling and
           laughing. Negative was determined to include discomfort, crying and unhappy facial
           expression.

        5. Vocalization/Gesture: The frequency (number of times) that the child vocalizes/gestures
           to a play toy or person, including grunting, shouting, vowel-type sounds (e.g., ee, i,
           ah, oo u).

      Repeated measure one way ANOVA was used to compare the mean difference of using a toy car for
      mobility, socialization and development before and after the intervention, and the follow-up.
      One way ANOVA was used to compare the mean difference of all developmental tests (mobility,
      socialization, motor, cognition) between two groups before and after the intervention and the
      end of follow-up phase. To analyze the learning curve, the results of socialization will be
      individually examined for each participant in two groups. The instant of the maximum training
      effect will be defined as the moment the top of the learning curve is reached. This top will
      be independently determined by two coders through visual examination of the absolute values.
      Subsequently, the data set will be split in children that have reached a maximum effect
      within the 9 weeks intervention period and those who have not. These two groups will then be
      compared with regard to demographic (age, gender) and clinical (manual ability classification
      system-MACS, gross motor function classification system-GMFCS) characteristics (using X2-test
      for dichotomous variables and Mann-Whitney U test/or t-test for the MACS and GMFCS depending
      on the normality of data).
    

Intervention name(s): Hospital-based Program; Regular Therapy Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment