A Randomized Controlled Trial of ride-on Car Training and Locomotor Experience in Toddlers With Different Motor Delays
Condition: Mobility Limitation
MeSH terms: Mobility Limitation
Study type: Interventional

Summary: 
      The three purposes of this study are: 1) to compare the effectiveness of the ROC-Stand
      training on mobility, psychosocial function and social looking with conventional therapy in
      toddlers with mild and moderate motor disabilities, 2) to compare the effectiveness of
      ROC-Stand training on body function level and environmental factors with conventional therapy
      in toddlers with mild and moderate motor disabilities, according to International
      Classification of Functioning, Disability and Health (ICF) levels, and 3) to determine the
      effects of ROC-Stand training on the relationship among social looking, caregiver-child
      interactions and mastery motivation in toddlers with mild and moderate motor disabilities.

      Based on the power analysis from the preliminary results of the pilot study, the investigator
      will recruit 92 toddlers with motor delays and further assign them to either mild or moderate
      motor delays group. The participants in each group will be randomly assigned to either the
      ROC-Stand training program or conventional therapy(Control) program, resulting the following
      four training groups: the ROC-Stand(Mild) group (n=23), the ROC-Stand(Mod) group (n=23),
      Control(Mild) group (n=23), and Control(Mod) group (n=23). The whole study duration will be
      24 weeks, including a 12-week intervention and a 12-week follow-up. All programs will include
      120 minutes/per session, 2 sessions/per week. Participants will continue their regular
      therapy during the whole study. 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. The head-mounted cameras worn by the participants and caregivers will record the
      social looking and interaction behaviors for one 2-hour session/per week during intervention.
      Participants will also wear three accelerometers throughout the 2-hour training. Assessments
      include mobility, socialization, behavioral coding, body function, family perception and
      participation. The findings of this study will provide us some optimal, alternative ways to
      enhance locomotor experience depending on each child's and family's needs.
    

Detailed description: 
      Locomotor posture as upright can increase infants' visual availability of destinations and
      induce their motivation to interact and explore with environment. Using a modified ride-on
      car (ROC) with a standing posture (ROC-Stand) may result in the similar effects. Our previous
      world's first randomized controlled trial (RCT) manipulated the parameters of the ROC
      experience by increasing the demands of postural control during the course of locomotion. The
      initial findings were positive and inspiring. After an intensive 12-week training program,
      toddlers with motor delays in the ROC-Stand group had significant improvements in mobility
      and social function. Moreover, the ROC-Stand group tended to have the most improvements than
      the ROC-Sit and conventional therapy groups, including mobility, social function and mastery
      motivation. The ROC-Stand group also had the highest goal achievement scores. In addition,
      the pilot results of caregivers' perceptions showed over 80% of the caregivers involved in
      the ROC training programs had decreased concerns on children's motor and social development.
      Their expectations changed due to the observed improvements in children's movements,
      cognition, and motivation. The intensive 3-month ROC training program, particularly the
      standing one, was feasible and beneficial for toddlers with motor delays and their
      caregivers.

      However, the severity level of motor delay should be considered in the early PMDs and require
      further investigation on the related treatment effects. Thus, a further study of toddlers
      with different severity levels of motor delays will provide us a full investigation on the
      effectiveness of ROC-Stand training on mobility, psychosocial function and locomotor
      experience. Moreover, the integration of information regarding the social looking behaviors,
      motor cost, caregiver-child interactions and caregivers' perceptions will be beneficial for
      clarifying the influences of these factors on the outcomes. The purpose of this study is to
      examine the effectiveness of ROC-Stand training on mobility, psychosocial function and social
      looking in toddlers with mild and moderate motor disabilities. To obtain the information of
      social looking and interactions with their caregivers, the investigator will use the
      lightweight, head-mounted action camera to record children's behaviors. Up to now, there is
      no ROC-related study applying this methodology to investigate the ecological validity in
      toddlers with motor delays. This design may help us to capture the novelty and variability of
      real-world locomotor experience regarding social looking, exploration and interactions.

      The specific aims of this study are: 1) to compare the effectiveness of the ROC-Stand
      training on mobility, psychosocial function and social looking with conventional therapy in
      toddlers with mild and moderate motor delays, 2) to compare the effectiveness of ROC-Stand
      training on body function level and environmental factors with conventional therapy in
      toddlers with mild and moderate motor delays, according to the ICF, and 3) to determine the
      effects of ROC-Stand training on the relationship among social looking, caregiver-child
      interactions and mastery motivation in toddlers with mild and moderate motor delays.

      Study Design: A randomized, multiple group pretest-posttest control group design will be
      applied. Four groups will be involved in this project: ride-on car training with a standing
      posture for toddlers with mild motor delays (ROC-Stand(Mild)), ride-on car training with a
      standing posture for toddlers with moderate motor delays (ROC-Stand(Mod)), conventional
      therapy for toddlers with mild motor delays (Control(Mild)) and conventional therapy for
      toddlers with moderate motor delays (Control(Mod)). The investigator will use stratified
      randomization. They will be arranged to one of the two groups based on the motor composite
      (MC) scores assessed by Bayley-III. Subsequently, the participants in each group will be
      randomly assigned to either the ROC-Stand training program or conventional therapy program by
      using a computer program (Research Randomizer Form www.randomizer.org). The study duration
      for each participant is 24 weeks, including a 12-week training phase (intervention) and a
      12-week follow-up phase.

      There will be 4 groups, including the ROC-Stand(Mild) group (23 toddlers), the ROC-Stand(Mod)
      group (23 toddlers), the Control(Mild) group (23 toddlers) and Control(Mod) 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 children will be recruited from self-referrals, health care practitioners,
      or the hospitals in Taipei and Taoyuan, Taiwan where children with motor delays are receiving
      outpatient rehabilitation. 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 randomization, the participants will receive pre-intervention measurements,
      including developmental assessments, the evaluations of environmental factors and
      self-developed questionnaires. The self-developed questionnaires were designed to examine
      parental perceptions on the training program 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 training programs. These assessments
      will occur on three occasions: before and after the 12-week training phase, i.e.,
      intervention (T1 & T2) and the end of the 12-week follow-up phase (T3). After the pretest,
      participants will be randomly assigned into 4 groups and started the training programs in the
      university.

      During the 12-week intervention, the locomotor experience of social looking behaviors and
      interactions for the four training groups will be videotaped by the head-mounted action
      cameras worn by the participants and the caregivers for one 2-hour session/per week at the
      university. In addition, participants will wear three accelerometers on their wrists and
      right hip to monitor the energy expenditure and activity counts during the intervention
      phase. An activity log used in the previous studies will also be applied in the 4 groups to
      record the training conditions and the caregiver's feedback on the training program every
      week during the 12-week intervention. The activity log will be mostly qualitative data that
      involves caregivers' descriptions. For the 12-week follow-up phase, all participants will not
      receive any training program from the research team. They only have their regular therapy
      from their own hospitals or clinics. The information of regular therapy, including the type,
      the frequency and the dosage, will be collected at T1, T2 and T3.

      Intervention: The research team and independent therapists will ask caregivers to identify
      goals (before the first training session), and measure progress using goal-attainment scaling
      (GAS) at T1, T2 and T3 time points for the four groups. Two independent licensed occupational
      therapists (OTs) who will not involve the administration of assessments will provide the
      ROC-Stand training and conventional therapy programs, respectively. All participants in the 4
      groups will continue their regular therapy from their own hospitals or clinics throughout the
      24-week duration of the study, including physical therapy, occupational therapy, and speech
      therapy. All groups will receive the training program in the university for 2 hours/per
      session, 2 sessions/per week for a total of 12-week intervention. On licensed, independent OT
      will provide the ROC training programs and the other licensed, independent OT will provide
      the conventional therapy. The training programs for the two ROC training groups will be based
      on the ecological and dynamic systems theory. All the programs will be discussed by the
      family, the treating therapist and the research team. The programs for the two control group
      will be based on developmental and motor learning theories.

      Follow-up: This period will involve a 12-week phase following the above treatment programs;
      during this time no treatment programs will be delivered to the participants except for their
      own regular therapy.

      Data Reduction and Analysis: Social Looking and Interactions Measures: To examine
      participant's social looking and interactive behaviors, the following measures will be
      obtained via coding video footage during the 12-week intervention phase. Because young
      children, like adults, keep their eyes relatively centered in view most of the time. Thus,
      studies have been applied the center of the visual field to indicate the focus point. On the
      basis of these studies, the coding variables included face looking, body/toy/environment
      looking, child's and social partner's vocalizations, child-initiated and caregiver-initiated
      vocalizations/gesture, concurrent/overlapping vocalizations, conversation units and visual
      scan.

      To compare the baseline characteristics of the major 2 groups categorized as mild and
      moderate motor delay, independent t-test (for data with normal distribution) and The
      Mann-Whitney U test (for data with non-normal distribution) will be conducted. 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.

      For those data collected during the 12-week intervention, descriptive statistics (frequency,
      means, standard deviations) of social looking and interactions will be calculated and
      repeated measures analysis of variance (group [4] × time [12]) will be used to compare the
      effects among the 4 training groups during intervention. Furthermore, the quantitative data
      of energy expenditure and activity counts obtained from the ActiGraph® during intervention
      will be organized and calculated. A repeated measures analysis of variance (group [4] × time
      [12]) will also be used to compare the differences among the 4 groups. The mean frequency of
      total social looking and interactions will be calculated from the coding results of the
      12-week intervention. SPSS 20.0 (SPSS Inc. Chicago, Illinois, USA) will be used for
      statistical analysis. Significance level will be set at p < 0.05.
    

Intervention name(s): A Ride-on Car with a Standing Posture; Regular Therapy Program
Intervention type(s): 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.; The goals are to improve certain motor skills or psychosocial skills based on each participant's current developmental stage. The general propose of the training is to facilitate the developmental scales and improve mobility, socialization and upper limb use in functional tasks. Each participant will have the opportunity to walk on the hallway/public space and interact with the therapist and caregivers depending on his/her motor abilities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: toddlers with motor delays; modified ride-on cars; severity level; locomotor experience; mobility; psychosocial function