Clinical trial NCT02527356: Advancing Mobility and Socialization in Toddlers With Disabilities: Modified Toy Cars Training With Different Postures
Official title: Advancing Mobility and Socialization in Toddlers With Disabilities: a Trial to Assess the Effects of Modified Toy Cars Training With Different Postures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children With Mobility Disabilities
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 37
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Motor delays resulting in motor impairments that prevented independent walking (standard deviation (SD) \< -1.5, assessed by the Chinese Child Development Inventory (CCDI) via a pediatric physician) )
2. Able to stand independently for 2 seconds or to tolerate standing with support for 10 minutes
3. Able to reach the objects with either one or two hands
4. The height is between 69 to 103 cm and the weight is between 7-18 kg
5. Consent of the parents to agree to the testing procedures and participate in the training program

Exclusion Criteria:

1. Children with severe sensory impairments such as blindness, deafness
2. The height is not between 69 to 103 cm and the weight is not between 7 to 18 kg
3. Parents/caregivers are not able to make a time commitment for the training phase.

Primary outcomes:
measure: Change from baseline in General Mobility and Social Development at 12 weeks and 24 weeks as assessed by the Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: Assessment will occur 3 times during the whole study, including the first and last week of the 12-week intervention, and the end of the 12-week follow-up phase
measure: Mobility/Driving Performance as assessed by the coding behaviors from the videotaping
timeFrame: The driving behaviors will be followed for the duration of implementing the intervention and follow-up program at the hospital, an expected average of 24 weeks.
measure: Socialization as assessed by the coding behaviors from the videotaping
timeFrame: The socialization behaviors will be followed for the duration of implementing the intervention and follow-up program at the hospital, an expected average of 24 weeks.
measure: Physical Activity for Exploration as assessed by the number of counts recorded from the accelerators wearing on both wrists
timeFrame: The physical activity for exploration behavior will be followed for the duration of implementing the intervention and follow-up program at the hospital, an expected average of 24 weeks.
Secondary outcomes:
measure: Change from baseline in Body Function/Structure at 12 weeks and 24 weeks as assessed by 5-repetition Sit-to-stand (STS) test
timeFrame: It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.
measure: Change from baseline in General Development at 12 weeks and 24 weeks as assessed by The Bayley Scales of Development
timeFrame: It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.
measure: Change from baseline in General Development at 12 weeks and 24 weeks as assessed by The Affordances in the Home Environment for Motor Development (AHEMD)
timeFrame: It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.
measure: Change from baseline in Participation level at 12 weeks and 24 weeks as assessed by The Goal Attainment Scale (GAS)
timeFrame: It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.
measure: Change from baseline in Parents' Perception at 12 weeks and 24 weeks as assessed by Parenting Stress Index (PSI)
timeFrame: It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.
measure: The Revised Dimensions of Mastery Questionnaire (DMQ 18) - Chinese version
timeFrame: It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
affiliation: Chang Gung University
name: HsiangHan Huang, ScD
role: PRINCIPAL_INVESTIGATOR
References: