Compare the Effectiveness of Modified Toy Cars Training With Various Intensity of Postural Combinations
Condition: Young Children With Motor Disabilities
Study type: Interventional

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.
    

Detailed description: 
      Some studies showed the use of laboratory-designed PMDs or modified ride-on cars (ROCs) might
      increase the child's independent mobility and motivation to master interpersonal tasks and
      result in positive changes on social functioning.

      Modified ROCs as a type of PMDs have become an innovative, alternative option to enhance
      independent mobility in children with disabilities. Studies have found that the novel
      application of modified ROCs in home-based, community-based or hospital-based environments
      might enhance independent mobility, motivation, and social function in young children with
      motor disabilities. In addition, these studies have indicated that the application of
      modified ROCs integrating the concept of family-centered service may be beneficial for
      improving young children's motivation due to their persistence on driving and increased
      pleasure during training.

      The dose-response effect of the ROC use with different postures on mobility function may be
      the reason relating to the previous findings. The progress of mobility function might be
      affected due to the focus on increasing socialization over mobility. Moreover, several
      studies have demonstrated that walking or standing may result in more energy expenditure than
      other postures, e.g., sitting or lying for children with disabilities. The ROC-stand training
      group required a total dynamic standing time of 60 to 70 minutes for driving and exploration
      during each session, which may increase the children's energy expenditure and result in less
      strength and endurance to move without the ROC. However, the standing posture may provide
      more opportunities and visual information for children to interact with other people and
      distal events, which relates to the development of socialization. With these outcomes and
      possible explanations, the investigators propose that the subsequent research may identify
      the "dose-response" effect of different postural combinations for the ROC use on mobility and
      social functions in toddlers with motor disabilities.

      In this study, the investigators will modify two types of ride-on toy cars for toddlers with
      disabilities for the use in the public spaces in the university as part of a 24-week power
      mobility training program. In addition, the investigators will compare the effectiveness of
      different intensity of postural combinations for the ROC training on mobility and
      socialization in toddlers with motor disabilities. The previous 2-hour ROC-training program
      included an average of 60-to-70-miniute driving (unstructured) and 50-minute natural play
      (structured) which involved exploration and motor skills training related to mobility and
      social impairments, such as postural stability, postural control, and social engagement.
      Based on the previous evidence, the investigators propose two groups which involve different
      intensity of postural combinations for the ROC use, i.e., one group of 45-minute sitting and
      25-minute standing and the other group of 25-minute sitting and 45-minute standing, may be
      optimal for toddlers with motor disabilities to meet the physical activity guidelines. the
      investigators further propose these postural combinations of the ROC use may have different
      effects on mobility and social function, compared to the original use with only one posture.
      A 4-group comparison design of decreased intensity of sitting posture and increased intensity
      of standing posture for the ROCs use may provide us a complete examination on the topic of
      dose-response effect on toddlers with disabilities. In addition, the investigators will
      examine whether the effects of increased independent mobility and socialization will affect
      toddler's function on the 3 International Classification of Function (ICF) domains. If our
      results are generally positive and show significant differences on independent mobility and
      socialization among the ROC training programs with two different postures and various
      intensity, it will provide us some alternative ways to improve independent mobility and
      socialization depending on children's and family's needs.

      The specific aims of this study are: 1) to determine the feasibility and examine the effects
      of ROC training with various intensity of postural combinations on mobility and socialization
      in toddlers with disabilities; 2) to objectively quantify the intensity and energy
      expenditure of postural combinations for the ROCs use through accelerometers; 3) to determine
      the effects of using the different modes of ROC training (different intensity of postural
      combinations) on the ICF functioning levels, family perceptions and participation.

      Method Study Design: A multiple group pretest-posttest control group design will be applied.
      Four groups will be involved in this project: ride-on car with sitting posture (ROC-sit),
      ride-on car with standing posture (ROC-stand), and two groups of ride-on car with mixed
      postures, including one group of 45-min sitting and 25-min standing postures (ROC-sit45 and
      stand25) and the other group of 25-min sitting and 45-min standing postures (ROC-sit25 and
      stand45). The study duration for each participant is 24 weeks, including 12-week intervention
      and 12-week follow-up.

      Participants: Participants in the study will be 92 toddlers ages 12 months to 36 months with
      motor delays. They will be randomly assigned to either the ROC-sit group (23 toddlers), the
      ROC-stand group (23 toddlers), the ROC-sit45 and stand25 group (23 toddlers) or the ROC-sit25
      and stand45 group (23 toddlers). The age group of infants/preschool children is selected
      based on the previous studies of ROC training in young children with motor disabilities.

      Recruitment: The participants will be recruited from self-referrals, health care
      practitioners, or the hospitals in Taipei or Taoyuan where toddlers with motor delays are
      receiving outpatient rehabilitations. The research team will initially post flyers describing
      the study at clinical settings and contact 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. The research team
      will contact the parent/guardian to explain study details and provide them the opportunity to
      ask questions. Children of parents/guardians who provide informed consent will participate in
      the study.

      Procedure: Each participant of the ride-on car training groups will have either a customized,
      sitting-style toy car or a standing-style toy car, depending on the assigned group. The
      adaptations are all assembled by PVC pipes which can be adjusted easily during each training
      session. After modifications, they will receive pre-intervention measurements, including
      developmental assessments, behavioral videotaping and self-developed questionnaires. The
      self-developed questionnaires were designed to examine parental perceptions on the PMDs use
      and children's capabilities in the previous studies. The pretest and posttest developmental
      assessments and questionnaires will be completed in a testing room at Chang Gung University
      by a licensed occupational therapist who is blinded to the study purpose and not involved in
      the treatment. These assessments will occur on three occasions: before and after the 12-week
      intervention (T1 & T2) and the end of the 12-week follow-up phase (T3). During the 12-week
      intervention, the locomotion (i.e., driving) and socialization behaviors for the four ROC
      training groups will also be videotaped by the research team for 1.5 hours during one
      session/per week at the university. In addition, participants will wear three accelerometers
      on their wrists and right hip to monitor the minutes of exercise, postural change, activity
      counts and energy expenditure for exploration during the whole 2-hour session, one
      session/each week for 12 weeks. An activity log will be applied to record the driving and
      play duration, driving locations, and the caregiver's feedback on the training program every
      week. All videotapes will be coded by two independent coders.

      Intervention: The research team will ask caregivers to identify goals (before intervention),
      and measure progress using goal-attainment scaling (GAS) at T1 and T2 time points for the
      four groups. The training principles are similar to those applied in our previous studies of
      ROC training in various environments. To record the total driving time, locations, and
      caregivers' feedback regarding training, an activity log will be used for each session. All
      groups will continue their regular therapy throughout the 24-week duration of the study,
      including physical therapy, occupational therapy, and speech therapy.

      Follow-up: This period will involve 12-weeks following the above treatment programs; during
      this time no treatment programs will be delivered to the participants except for their own
      regular therapy.

      Instrument and Procedure: To present a complete investigation of participants' changes on the
      3 domains of ICF, home affordances and parenting stress levels, the investigators will
      provide standardized assessments as the quantitative measures at T1, T2, and T3, and
      behavioral observations and activity logs as the qualitative measures during the
      intervention. In addition, accelerometers will be applied during the intervention to provide
      a quantitative measure for exploration, including the minutes of exercise, postural change,
      activity counts and energy expenditure.

      Data Reduction and Analysis Quantitative measures at T1, T2, and T3 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.

      Descriptive statistics including frequency, means, standard deviations, as well as
      nonparametric data medians and interquartile ranges will be calculated. Data will be analyzed
      based on an intention-to-treat analysis. A repeated measures analysis of variance (group [4]
      × time [3]) will be employed to evaluate the treatment effects on the primary and secondary
      outcomes among the 4 groups at T1, T2, and T3, followed by a post-hoc analysis using
      Bonferroni test to determine between which groups the differences occur.

      Descriptive statistics (frequency, means, standard deviations) of each behavior will be
      calculated and repeated measures analysis of variance (group [4] × time [12]) will be used to
      compare the effects of behavioral measures among the 4 groups during intervention.
      Furthermore, the quantitative data obtained from the accelerometers during intervention will
      be organized and calculated. A repeated measures analysis of variance (group [4] × time [12])
      will also be used to compare the effects related to exploration among the 4 groups during
      intervention.
    

Intervention name(s): Ride-On Cars Training with Different Postures
Intervention type(s): Behavioral
Intervention description(s): 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.
Other intervention name(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment