In the Driver's Seat: A Randomized, Crossover Clinical Trial Protocol Comparing Home and Community Use of the Permobil Explorer Mini and a Modified Ride-On Car by Children With Cerebral Palsy
In the Driver's Seat: A Randomized, Crossover Clinical Trial Protocol Comparing Home and Community Use of the Permobil Explorer Mini and a Modified Ride-On Car by Children With Cerebral Palsy
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DOI：
10.1093/ptj/pzac062
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发表时间：
2022-07-04
期刊：
影响因子：
3.2
通讯作者：
Kenyon, Lisa K.
中科院分区：
文献类型：
--
作者：
Feldner, Heather A.;Logan, Samuel W.;Kenyon, Lisa K.
目的本研究的目的有两个方面：（1）评估动力移动干预，以促进12至36个月的脑瘫幼儿的发育，活动和参与结果;（2）比较2种不同动力移动选项的使用模式（频率，持续时间，环境）。方法本研究是一项多中心、混合方法、双重平衡、随机、交叉临床试验，干预A是Permobil Explorer Mini，干预B是改良的乘坐玩具车。本研究将在3个研究中心（华盛顿、俄勒冈州和密歇根州）周围的农村和城市家庭和社区环境中进行。研究中将有24对儿童-护理人员（每个研究中心8对）。主要结果指标包括婴儿和幼儿发展的贝利量表，青少年和儿童的参与和环境措施，评估学习能力的移动性使用，自动化设备使用跟踪日志，照顾者半结构化访谈，以及可接受性，可行性和干预适当性措施。次要措施包括儿童参与日常生活和照顾者日记。对脑瘫幼儿使用电动移动设备已经获得了牵引力，有证据表明，在年幼时使用电动移动设备补充（而不是减损）了其他专注于爬行和行走等更传统移动技能的干预措施。然而，研究是有限的，而且往往是低水平的证据。鉴于第一个电动移动设备的婴儿，Permobil Explorer迷你，和最近流行的修改骑在玩具汽车作为一种替代动力移动幼儿残疾人，本研究将有助于严格检查的发展成果，使用模式，和照顾者的看法，这些新的设备。
Objective The aims of this study are 2-fold: (1) to evaluate a powered mobility intervention to promote developmental, activity, and participation outcomes of young children aged 12 to 36 months who have cerebral palsy; and (2) to compare the use patterns (frequency, duration, environment) of 2 different powered mobility options. Methods This study is a multisite, mixed-methods, doubly counterbalanced, randomized, crossover clinical trial, where intervention A is the Permobil Explorer Mini and intervention B is a modified ride-on toy car. The study will take place in rural and urban home and community settings surrounding 3 sites (Washington, Oregon, and Michigan). There will be 24 child-caregiver dyads in the study (8 dyads per site). Primary outcome measures include the Bayley Scale of Infant and Toddler Development, the Youth and Children's Participation and Environment Measure, the Assessment for Learning Power mobility use, automated device use tracking logs, caregiver semistructured interviews, and the Acceptability, Feasibility, and Intervention Appropriateness Measures. Secondary measures include the Child Engagement in Daily Life and caregiver diaries. Impact The use of powered mobility devices for young children with cerebral palsy has gained traction, with evidence that the use of powered mobility at young ages complements (rather than detracts from) other interventions focused on more traditional mobility skills such as crawling and walking. However, research is limited, and often comprised of low-level evidence. Given the clearance of the first powered mobility device for infants, the Permobil Explorer Mini, and the recent popularity of modified ride-on toy cars as an alternative for powered mobility for young children with disabilities, this study will contribute to rigorous examination of the developmental outcomes, use patterns, and caregiver perceptions of these novel devices.