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Study protocol of a randomized controlled trial of home-based computerized executive function training for children with cerebral palsy.
BMC Pediatrics ( IF 2.4 ) Pub Date : 2020-01-07 , DOI: 10.1186/s12887-019-1904-x
María García-Galant 1, 2, 3 , Montse Blasco 1, 2, 3 , Lee Reid 4 , Kerstin Pannek 4, 5 , David Leiva 6 , Olga Laporta-Hoyos 1, 2, 3 , Júlia Ballester-Plané 1, 2, 3 , Júlia Miralbell 1, 2, 3 , Xavi Caldú 1, 2, 3 , Xènia Alonso 7 , Esther Toro-Tamargo 8 , Mar Meléndez-Plumed 8 , Francisca Gimeno 9 , Marc Coronas 10, 11 , Emili Soro-Camats 10, 11 , Roslyn Boyd 5 , Roser Pueyo 1, 2, 3
Affiliation  

BACKGROUND Cerebral palsy (CP) is frequently associated with specific cognitive impairments, such as executive dysfunction which are related to participation and quality of life (QOL). The proposed study will examine whether a computerized executive function (EF) training programme could provide superior benefits for executive functioning, participation, QOL and brain plasticity, as compared to usual care. METHODS A single-blind randomized controlled trial (RCT) design will be performed. Thirty children with CP aged 8 to 12 years will participate in a home-based computerized multi-modal executive training programme (12 weeks, 5 days a week, 30 min a day training, total dose = 30 h). Thirty children with CP matched by age, sex, motor and intelligence quotient (IQ) will compose the waitlist group. Cognitive, behavioural, emotional, participation and QOL measures will be obtained at three time points: before, immediately after and 9 months after completing the training. Additionally, structural and functional (resting state) magnetic resonance images (MRI) will be obtained in a subsample of 15 children from each group. Outcomes between groups will be compared following standard principles for RCTs. DISCUSSION The study will test whether the cognitive training programme exerts a positive effect not only on neuropsychological and daily functioning of children with CP but also on other measures such as participation and QOL. We will also use brain MRI to test brain functional and structural changes after the intervention. If this on-line and home-based training programme proves effective, it could be a cost-effective intervention with short- and long-term effects on EF, participation or QOL in CP. TRIAL REGISTRATION ClinicalTrials.gov: NCT04025749. Registered 19 July 2019. Retrospectively registered.

中文翻译:

脑瘫儿童家庭计算机执行功能训练的随机对照试验研究方案。

背景技术脑瘫(CP)经常与特定的认知障碍相关,例如与参与和生活质量(QOL)相关的执行功能障碍。拟议的研究将检验与常规护理相比,计算机化执行功能 (EF) 培训计划是否可以为执行功能、参与、生活质量和大脑可塑性提供卓越的益处。方法 将进行单盲随机对照试验 (RCT) 设计。30 名 8 至 12 岁患有 CP 的儿童将参加以家庭为基础的计算机化多模式执行训练计划(12 周,每周 5 天,每天 30 分钟训练,总剂量 = 30 小时)。30 名年龄、性别、运动和智商 (IQ) 相匹配的 CP 孩子将组成候补名单组。认知、行为、情感、将在三个时间点获得参与度和 QOL 测量值:培训前、培训后和培训结束后 9 个月。此外,将从每组 15 名儿童的子样本中获得结构和功能(静息状态)磁共振图像 (MRI)。组间的结果将按照 RCT 的标准原则进行比较。讨论 该研究将测试认知训练计划是否不仅对 CP 儿童的神经心理和日常功能产生积极影响,而且对参与和生活质量等其他指标也产生积极影响。我们还将使用大脑 MRI 来测试干预后的大脑功能和结构变化。如果这种在线和家庭培训计划被证明是有效的,它可能是一种具有成本效益的干预措施,对 EF 有短期和长期影响,CP 的参与或生活质量。试验注册 ClinicalTrials.gov:NCT04025749。2019 年 7 月 19 日注册。追溯注册。
更新日期:2020-01-07
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