Compare the Effectiveness of Modified Toy Cars Training With Various Intensity of Postural Combinations on Mobility and Socialization in Toddlers With Motor Disabilities: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Socialization
研究概览
简要总结
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.
详细描述
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.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 3 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •motor delays that resulted in motor impairments that prevented independent walking (standard deviation (SD) > 1.5, assessed by the Chinese Child Development Inventory59,60 via a pediatric physician)
- •can stand independently for two seconds or to tolerate standing with support for 10 minutes
- •can reach objects with either one or two hands
- •the height is between 69 to 103 cm and the weight is between 7-18 kg
- •parents are able to provide consent for their child's participation in the ROC training programs.
排除标准
- •children with severe sensory impairments such as blindness, deafness
- •the height is not between 69 to 103 cm and the weight is not between 7 to 18 kg
- •parents/caregivers are not able to make a time commitment for the training phase
结局指标
主要结局
Socialization
时间窗: 40 minutes/per week for a total of 12 weeks
The behaviors of social interactions are obtained during the most active 30 minutes of driving and the most active 10 minutes of the recorded 20-minute natural play, i.e., the first 20 minutes of natural play. From these videotapes, the frequency and duration of the following will be coded: physical contacts, initiation of contact with others, other initiated contacts, facial expressions, vocalizations/gestures and mutual play events (e.g. sharing an object or a toy).
Change from Posttest Mobility and Social Function at 12 Weeks
时间窗: PEDI will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3).
The Chinese version of Pediatric Evaluation of Disability Inventory (PEDI-C) is a set of tests for children from 8 months to 6 years old. The PEDI-C quantifies self-care, mobility, and social function, and is particularly useful for tracking changes in functional skills. Each domain can be used separately for data analysis. The inter-rater and intra-rater reliabilities of the study reveal excellent agreement of the observations (0.95-0.99), and good concurrent validity with the Functional Independence Measure for Children (Spearman ρ, 0.92-0.99).
Mobility-Driving Performance
时间窗: 30 minutes/per week for a total of 12 weeks
Every week during the intervention phase, the 70-minute driving will be recorded and the most active 30 minutes will be selected for coding. The following behaviors will be coded, including driving categories (independent mobility, assisted mobility, caregiver mobility), visual attention to the switch and stopping categories (independent stop, stops with verbal cues, stops with tactile contacts).
Change from Baseline Mobility and Social Function at 12 Weeks
时间窗: PEDI will be administered on two occasions: before and after the 12-week intervention (T1 & T2).
The Chinese version of Pediatric Evaluation of Disability Inventory (PEDI-C) is a set of tests for children from 8 months to 6 years old. The PEDI-C quantifies self-care, mobility, and social function, and is particularly useful for tracking changes in functional skills. Each domain can be used separately for data analysis. The inter-rater and intra-rater reliabilities of the study reveal excellent agreement of the observations (0.95-0.99), and good concurrent validity with the Functional Independence Measure for Children (Spearman ρ, 0.92-0.99).
次要结局
- Change from Baseline Sit-to-Stand at 12 Weeks(This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2).)
- Change from Posttest Sit-to-Stand at 12 Weeks(This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3).)
- Change from Baseline Developmental Abilities at 12 Weeks(This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2).)
- Change from Baseline Home Affordances at 12 Weeks(This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2).)
- Change from Baseline Mastery Motivation at 12 Weeks(This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2).)
- Change from Posttest Mastery Motivation at 12 Weeks(This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3).)
- Change from Posttest Home Affordances at 12 Weeks(This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3).)
- Change from Posttest Goal Achievements at 12 Weeks(This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3).)
- Change from Posttest Developmental Abilities at 12 Weeks(This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3).)
- Change from Baseline Goal Achievements at 12 Weeks(This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2).)
- Change from Baseline Parental Stress at 12 Weeks(This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2).)
- Change from Posttest Parental Perceptions at 12 Weeks(This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3).)
- Energy expenditure for Exploration(2 hours each week for a total of 12 weeks)
研究者
Hsiang-Han Huang
Assistant Professor
Chang Gung Memorial Hospital
