Advancing Mobility and Socialization in Toddlers With Disabilities: Modified Toy Cars Training With Different Postures
Condition: Children With Mobility Disabilities
Study type: Interventional

Summary: 
      The three purposes of this study are: 1) to examine the feasibility and effects of ride-on
      car training with two different postures on mobility and socialization in toddlers with
      disabilities; 2) to quantify whether toddlers with disabilities are able to have more
      exploratory behaviors and social interactions with ride-on car training through observation
      and wrist-worn accelerators; 3) to determine the critical factors of using the different
      modes of modified ride-on toy car on family perceptions and participation.

      The concept of using modified ride-on toy cars (ROC) in therapy has became a novel
      application in recent years. This study is further to examine the effects of ride-on toy car
      training with two different postures, i.e., sitting and standing , on independent mobility,
      exploration and socialization through low-cost, family-centered approach. It will also
      improve family's understanding of children's capabilities, which improves their development.
      Based on the power analysis from the preliminary results of investigator group study,
      investigators will recruit 60 children with disabilities who are between 1 to 3 years old and
      diagnosed as motor delay. They will be randomly assigned to one of the following three
      groups: ROC-Sit group, ROC-Stand group and regular therapy group. 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 three 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 ROC-Sit and ROC-Stand 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 let participants
      wear wrist-worn accelerators. 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 behavioral coding
      from the videotapes and accelerators. The findings of this study will provide a novel
      therapeutic tool (i.e., combining the low-tech modified ride-on cars with different postures)
      on advancing children's mobility, socialization, family participation and development.
    

Detailed description: 
      Pediatric rehabilitation, through training and assistive technology (AT), seeks to provide
      children with disabilities with the same level of mobility, exploration, socialization and
      participation for children with typical development (TD). 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 and exploration that children, families and therapists desire. Currently,
      the most critical barrier to including power mobility in EI programs is the lack of readily
      available power chairs for children younger than 2-3 years of age, the period when mobility
      is rapidly developing for children with TD. 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, size and weight, transportation
      requirements, maintenance, aesthetics and social acceptance. Experimental power mobility
      devices (PMD) have the potential to address some of these limitations such as size, weight
      and infant use. Unfortunately these are likely years from commercial availability. Moreover,
      power wheelchairs have historically been designed to address a limited set of goals related
      to mobility with minimal consideration of socialization. Although of increasing interest,
      there is very little empirical evidence of the effects or even feasibility of early power
      mobility training on overall development and the family participation, particularly for
      socialization. Investigator 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 PMD past simply mobility and into socialization.

      In this study, investigator will modify two types of modified ride-on cars (ROCs) for
      toddlers with disabilities for the use in clinical settings as part of a 24-week power
      mobility training program. In addition, investigator will compare the effects of applying
      early power mobility training to the regular therapy on development. Investigator will focus
      on four research questions. Specifically, can investigator: 1) use the modified toy cars with
      two different postures as effective power mobility training programs to improve the
      independent mobility and socialization; 2) select a set of dependent measures that quantify
      whether the children increase their exploratory and social behaviors; 3)conduct a
      hospital-based, power mobility training program that results in a high level of fun for the
      child and compliance by the family and therapists. In addition, investigator will examine
      whether the effects of increased independent mobility and socialization will affect toddler's
      function with the 3 International Classification of Function (ICF) domains. If investigator
      results are generally positive and show significant differences on independent mobility and
      socialization among the early power mobility training programs with two different postures
      and regular therapy, it will provide us some alternative ways to advance independent mobility
      and socialization. Subsequently, the further randomized controlled trial studies can quantify
      the effectiveness and the feasibility with different treatment intensity and various
      pediatric populations.

      The specific aims of this study are: 1) to examine the feasibility and effects of ROC
      training with two different postures on mobility and socialization in toddlers with
      disabilities; 2) to quantify whether toddlers with disabilities are able to have more
      exploratory behaviors and social interactions with ROC training through observation and
      wrist-worn accelerometers; 3) to determine the critical factors of using the different modes
      of modified ROC on family perceptions and participation. Through the comparison among the two
      ROC training groups (i.e., treatment groups) and regular therapy group (i.e., control group),
      investigator hypothesize that both groups of ROC training will have more improvements on
      functional mobility, socialization and parenting stress than the control group. Specifically,
      the treatment group of ROC training with standing posture will have more increased social
      function than the sitting posture in the ROC training and control group. In addition,
      toddlers in both treatment groups will have more physical activity for exploration, in
      comparison with the control group. Investigator also hypothesize that ROC training with
      different postures will elicit different family perceptions on the child's capabilities and
      themselves, i.e., caregivers, in comparison with the regular therapy.

      Study Design: A multiple group pretest-posttest control group design will be applied. Three
      groups will be involved in this project: ride-on car with sitting posture (ROC-Sit), ride-on
      car with standing posture (ROC-Stand) and regular therapy. The participants will be randomly
      assigned to one of the three groups by using the well-sealed, opaque envelopes when they are
      recruited in the study. Once the participants are recruited in the study, the research team
      will modify a toy car based on each participant's group and capabilities during this
      pre-intervention phase (the first two or three weeks before intervention starts), e.g., seat
      and steering wheel modifications. All the modifications can be disassembled so they can be
      adjusted based on each participant's progress during the intervention. The study duration for
      each participant is 24-week, including 12-week intervention and 12-week follow-up.

      Participants in the study will be 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.

      Recruitment: The children will be recruited from self-referrals, health care practitioners,
      or the hospitals in Taipei and Taoyuan, Taiwan where children with motor delays (>1.5 sd) are
      receiving outpatient rehabilitation. The research team will initially post 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 will
      obtain information about the study through the flyers and their therapists. When the research
      team contacts the parents, study will be explained and parents will receive a letter
      detailing the procedure and given an opportunity to ask questions. Parents/guardians will
      sign this informed consent form at the time of the first visit.

      Procedure: Before the pre-intervention assessments, the research team will modify the car's
      seat and acceleration to the hand switch-driven, which allows the car to be derivable for the
      participant who meets the inclusion criteria. Each participant of the ROC training groups
      will have either a customized, sitting-style toy car or a standing-style toy car, depending
      on the assigned group. In addition to the original design of the sitting-style toy car in
      investigator previous studies, investigator have added the seat height, extra seat belts and
      pipe frame to ensure the participant's safety and the whole device's stability during the
      standing mode of locomotion. After modifications, they will receive pre-intervention
      assessments, including behavioral videotaping and developmental assessments. The
      developmental assessments will occur at the first and last week of the 12-week intervention,
      and the end of the 12-week follow-up phase. A therapist who does not involve in the
      intervention and is blinded to the study purpose will complete all the developmental tests.
      The driving and socialization behaviors will be videotaped by the research team for 1
      hour/per session, 1 session/per week before, during and after the intervention phase at the
      hospital. In addition, participants will wear two accelerometers on their wrists to monitor
      the physical activity during the 1 hour videotaping session. 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 by the PI, but he/she is not informed about the
      group assignment and the purpose of the study.

      Intervention The research team will ask caregivers to identify goals (before intervention),
      and measure progress using goal-attainment scaling (GAS) before and after the intervention
      for the three groups. All three groups will continue their regular therapy during the
      intervention phase. Each group will receive the ROC training or the conventional therapy for
      2 sessions/per week during this phase. The ROC training includes driving the ROC with a
      sitting or a standing posture based on the ecological and dynamic systems theories. The
      regular therapy group will receive additional conventional therapy based on the developmental
      and motor learning theories.

      Follow-up This period will focus on the 12-week follow-up after receiving a treatment
      program. No treatment programs will be delivered to the participants. The research team will
      still videotape the child's natural play and driving performance at the hospital for 1 hour
      /per session, 1 session/per week during the 12-week follow-up phase.

      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.

      From the 1 hour filmed session during intervention, each participant's 20 'most active'
      minutes of 2 training play sessions (i.e., 10 minutes of driving and 10 minutes of natural
      play) are selected for coding. Thus, the 20-minute 'most-active' minutes are categorized as
      10-minute 'Car Play' (from driving training) and 10-minute 'Natural Play'. Mobility Measures
      The behavioral 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.

      Repeated measure one way ANOVA will be used to compare the mean difference of using different
      toy cars on mobility, socialization and exploratory behaviors before and after the
      intervention, and after 12-week follow-up, i.e., within group comparison. One way ANOVA will
      be used to compare the mean difference of all developmental tests, participation and physical
      activity for exploration among three groups before and after the intervention and the end of
      follow-up phase.
    

Intervention name(s): Ride-On Cars with Standing Posture (ROC-Stand); Ride-On Cars with Standing Postures (ROC-Sit); Regular Therapy Program
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The 2-hour training session is composed of two 30-minute driving sessions and two 25-minute natural play sessions, with a 10-minute break. Every week's treatment program will be before planned and adjusted by the therapist and the caregivers through discussion and clinical observation of participant's performance in the previous session. Training will concentrate on building the concept of casual-effect on the switch and car motion, goal-oriented driving in a hospital, and upper limb use in functional tasks with driving and hand use in functional tasks for exploration in natural play session.; Most of the guidelines are similar with ROC-Stand, except for the posture of driving. The training time and period is the same as ROC-Stand. The two 30-minute driving sessions can also be divided into 4 times of 15-minute sessions, depending on the child's standing ability with supported condition.; The research team will ask caregivers to identify goals (before intervention), and measure progress using goal-attainment scaling (GAS). The regular therapy group will continue the regular therapy, including physical, occupational and speech therapy. In addition, they will receive training program in a hospital for 2 hours/per session, 2 sessions/per week for a total of 12-week intervention. The participants will also experience the two 30-minute car driving sessions during the whole 2-hour training. The difference between the regular therapy group and the two ROC groups is the experience of car driving is controlled by the therapist, i.e. passive locomotion. 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 for 1 hour/per session, 1 session/per week during the 12-week intervention phase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment