The Effects of Combining Modified ride-on Cars With Bimanual Training on Enhancing Mobility, Socialization, Motor Function and Participation in Toddlers With Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change from baseline in General Mobility and Social Development at 9 weeks and 18 weeks as assessed by the Pediatric Evaluation of Disability Inventory (PEDI)
研究概览
简要总结
The four purposes of this study are: 1) to examine the feasibility of combining modified ride-on cars with bimanual training (ROCBT) on mobility, socialization and motor function in toddlers with disabilities; 2) to quantify whether toddlers with disabilities are able to have more manual explorations and social interactions with ROCBT through observation and wrist-worn accelerometers; 3) to determine the critical factors of using the modified ride-on toy car on family perceptions and participation.
Independent mobility is believed to be essential for perceptual-motor, cognition, language and social skill development. It is important to increase independent mobility in toddlers with disabilities and further enhance their development, especially socialization. Assistive and power mobility devices allow toddlers 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, and social acceptance of the device and the adaptability of the device to growth. To address these limitations and meet toddlers' needs, the concept of using modified ride-on toy cars in therapy becomes a novel application. Study has demonstrated the use of toy cars enhanced a child's motivation, socialization and family participation. This study is further to combine the use of customized, modified ride-on toy cars with bimanual training, to enhance the independent mobility, manual 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 75 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 three groups: ROCBT treatment group, early mobility training 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. 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 ROCBT and early mobility training 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 wearing wrist-worn accelerometers. 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 behavior coding from the videotapes and accelerometers. The findings of this study will help to understand the feasibility and effectiveness of combining the low-tech modified ride-on cars with bimanual training on advancing children's mobility and socialization. They can be used in the clinic or school and are a low cost alternative or addition to other mobility devices. They may provide a novel therapeutic tool to improve mobility, socialization, family participation and development.
详细描述
Spontaneous self-initiated actions have consequences, and experiencing these is very educational. Independent mobility is believed to be essential for perceptual-motor and social skill development. Self-produced locomotion is an organizer of psychological changes in children with typical development, especially developmental changes in perceptions, social understanding, spatial cognitive, and emotions. In addition, through active manual exploration, children can detect the object and individual's information that relates size, orientation, shape, substance to their perceptual and movement capabilities and interpersonal relationships. Children require exploratory behaviors to gather relevant information for a task. They can learn the relationship between the object-surface and movements through increased independent mobility and manual exploration. There is convincing evidence that the use of powered mobility for children with disabilities has positive impacts on their overall development and increases their exploration. Studies are focusing on reducing the limitations in the areas of social, cognitive, perceptual, and functional development that were induced by lack of independent mobility in early ages. Limited evidence also demonstrated that early powered mobility training had positive impacts on the family participation, including decreasing parents' level of stress and increasing their satisfaction with their child's sleep patterns, ability to move out, and ability to interact and socialize with the family.
Pediatric rehabilitation, through training and assertive technology (AT), seeks to provide children with disabilities with the same level of mobility, exploration, socialization and participation for children with typical development (TD). Proponents of powered vehicles for very young children present strong reasons for introducing powered mobility to children at a time in their developmental pattern that coincides as closely as possible to when they would have begun independent mobility as a child with TD. Research has suggested that there is no negative influence on motor development or self-care abilities. In addition, children with disabilities may be more motivated to participate in therapy and may demonstrate increased head, trunk and arm-hand control for exploration in the surrounding environment. However, up to date, the lack of rigorous studies and limited evidence of the increased independent mobility and early child development across all three International Classification of Functioning, Disability and Health (ICF) levels, still signify the needs of considering early power mobility as a feasible intervention in the clinical settings for very young children who have not yet achieved a means of independent mobility and are unlikely to achieve it.
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 typical development. 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. 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. 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 PMD past simply mobility and into socialization.
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 electromagnetically devices, they can be modified quickly and easily to match the child's current and/or future abilities and goals. 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.
From our initial pilot results, it indicated that this early powered mobility training through the use of modified toy cars might enhance cognition, language, mobility, and socialization in toddlers with mobility impairments. However, the fine and gross motor remained at a similar level before and after 9-week intervention. These initial findings suggest a number of important points: 1) early power mobility training may increase exploratory behaviors and benefit independent mobility, cognitive and social development; 2) the improvements of children's development and caregiver's involvement in the training may decrease family stress level and increase family participation; 3) simple early power mobility training may not be enough to improve motor function. Better postural control coupled with reaching and grasping ability allows infants to independently explore objects in new ways for sustained periods through mouthing and touching. The seat adjustments (e.g., a seat belt er, a hip strap) of ride-on toy cars may provide sufficient postural stability for the child with disabilities, however, the impaired reaching and grasping ability may decrease the opportunities of doing manual exploration for both hands. Most daily activities are functional tasks and may require two hands doing different actions. The development of increased functional independence requires use of both hands in cooperation. Gordon et al. had asked caregivers to identify goals for the intervention, and measured the progress using goal-attainment scale (GAS). Nearly 85% of the goals were bimanual. Principles of motor learning (practice specificity) suggest the most functional way to balance the cortical activity and improve bi-manual control would be to practice bi-manual activities directly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 36 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •motor delays (sd>1.5) resulting in motor impairments that prevented functional independent mobility, such as rolling, crawling, walking;
- •aged between 12 months to 36 months old
- •able to tolerate sitting with support for 30 minutes
- •able to reach the objects with either one or two hands
- •consent of the parents to agree to the testing procedures and participate in the training program at the hospital.
排除标准
- •children with severe sensory impairments such as blindness, deafness
- •parents/caregivers are not able to make a time commitment for the training phase
结局指标
主要结局
Change from baseline in General Mobility and Social Development at 9 weeks and 18 weeks as assessed by the Pediatric Evaluation of Disability Inventory (PEDI)
时间窗: Assessment will occur 3 times during the whole study, including the first and last week of the 9-week intervention, and the end of the 9-week follow-up phase.
PEDI is a set of tests for children from 8 months to 6 years old. The PEDI quantified self-care, mobility, and social functions. The PEDI is especially useful for tracking changes in functional skills.
Physical activity as assessed by the amount of counts from the wrist accelerometers
时间窗: The physical activity will be recorded for the duration of implementing the intervention program at the hospital, an expected average of 9 weeks.
Each week the participant will wear the accelerometers on both wrists during the 1 hour videotaping session, including 30-minute driving and 30-minute natural play. The accelerometers code the physical activity for driving and playing.
Mobility/Driving Performance as assessed by the coding behaviors from the videotaping
时间窗: The driving behaviors will be followed for the duration of implementing the intervention program at the hospital, an expected average of 9 weeks.
The driving behaviors will be coded from each 10-minute Car Play session: a) amount of time moving/total time, b) frequency, time and duration of parental assistance (physical and/or vocal), c) number of successful "directional driving trials". In each of 10 trials, the child is asked to drive 5 feet to the parent or researcher. He/she is given 30 seconds to complete the distance and make a stop at the goal.
Socialization as assessed by the coding behaviors from the videotaping
时间窗: The socialization behaviors will be followed for the duration of implementing the intervention program at the hospital, an expected average of 9 weeks.
The frequency and duration related to socialization will be coded during the whole 20-minute Play, including 10-minute Natural Play and 10-minute Car Play: physical contacts, initiation of contact with others, other initiated contacts, facial expressions, vocalizations/gestures and mutual play events (ex. sharing a toy).
次要结局
- Change from baseline in Parents' Perceptions at 9 weeks and 18 weeks as assessed by Parenting Stress Index (PSI)(It will be administered a total of 3 times during the whole study, including the beginning and end of the 9-week intervention, and the end of the 9-week follow up.)
- Change from baseline in General Development at 9 weeks and 18 weeks as assessed by the Affordances in the Home Environment for Motor Development (AHEMD)(It will be administered a total of 3 times during the whole study, including the beginning and end of the 9-week intervention, and the end of the 9-week follow up.)
- The Revised Dimensions of Mastery Questionnaire (DMQ 18) - Chinese version(it will be administered a total of 3 times during the whole study, including the beginning and end of the 9-week intervention, and the end of the 9-week follow up.)
- Change from baseline in General Development at 9 weeks and 18 weeks as assessed by The Bayley Scales of Development(It will be administered a total of 3 times during the whole study, including the beginning and end of the 9-week intervention, and the end of the 9-week follow up.)
- Change from baseline in General Development at 9 weeks and 18 weeks as assessed by the Goal Attainment Scale (GAS)(It will be administered a total of 3 times during the whole study, including the beginning and end of the 9-week intervention, and the end of the 9-week follow up.)
