背景:接受心脏直视手术的先天性心脏病(CHD)儿童有发育障碍的风险,包括电机延迟,这有助于父母的担忧。此外,父母经历与孩子的疾病相关的长期压力。CHD婴儿缺乏早期运动干预,这是父母负担的原因。我们开发了家庭定制的早期运动干预(EMI-Heart),旨在促进CHD婴儿的运动发育和家庭幸福。主要目的是评估研究设计和干预的可行性。次要目的是评估干预组和对照组在基线(3-5个月)运动结果和家庭幸福感方面的差异。治疗后(6-8个月),并在随访(12个月)。
方法:在这项单中心可行性随机对照试验(RCT)中,在心脏直视手术后无遗传或主要神经系统合并症的CHD婴儿被随机分配到EMI-Heart组和对照组(标准治疗).EMI-心脏的关键要素促进姿势功能活动,并鼓励父母对婴儿运动和行为线索的敏感性。分配给EMI-Heart的婴儿在家中接受了9次早期运动干预,在医院里,并由儿科物理治疗师在线持续3个月。我们对可行性和次要结果进行了描述性统计。
结果:招聘率为59%(10/17),所有参与的家庭都完成了研究(10/10),干预持续时间为3.9个月(±0.54),包括每个家庭九次干预会议。父母的可接受性中位数为3.9(1=不同意-4=完全同意,李克特量表)。儿科物理治疗师认为干预是可行的。运动结果的比较未显示组间差异。然而,与对照组相比,我们发现干预组家庭的家庭幸福感结局的可靠变化评分有所改善.
结论:我们的研究表明,EMI-Heart是对心脏直视手术后的CHD婴儿的可行干预措施。父母和儿科物理治疗师都高度接受该干预措施。在线治疗会议提供了一个有价值的替代家庭和医院访问。这种可行性RCT为未来的全面试验提供了基础。
背景:ClinicalTrials.gov,NCTT04666857。注册23.11.2020。
BACKGROUND: Children with congenital heart disease (CHD) who undergo open-heart surgery are at risk of developmental impairment, including motor delay, which contributes to parental concerns. Additionally, parents experience prolonged stress associated with their child\'s disease. There is a lack of early motor interventions in infants with CHD accounting for parental burdens. We developed a family-tailored early motor intervention (EMI-Heart), aiming to promote motor development in infants with CHD and family well-being. The primary aim was to evaluate the feasibility of the study design and the intervention. The secondary aim was to evaluate differences between the intervention and the control group in motor outcomes and family well-being at baseline (3-5 months), post-treatment (6-8 months), and at follow-up (12 months).
METHODS: In this single-centre feasibility randomized control trial (RCT), infants with CHD after open-heart surgery without genetic or major neurological comorbidities were randomly allocated to EMI-Heart or the control group (standard of care). EMI-Heart\'s key elements promote postural functional activities and encourage parental sensitivity to infants\' motor and behaviour cues. Infants assigned to EMI-Heart received nine sessions of early motor intervention at home, in the hospital, and online for a duration of 3 months by a paediatric physiotherapist. We performed descriptive statistics for feasibility and secondary outcomes.
RESULTS: The recruitment rate was 59% (10/17), all participating families completed the study (10/10), and the intervention duration was 3.9 months (± 0.54), including nine intervention sessions per family. Median acceptability to parents was 3.9 (1 = not agree-4 = totally agree, Likert scale). The paediatric physiotherapist considered the intervention as feasible. The comparison of motor outcomes did not show differences between groups. However, we detected improved reliable change scores in family well-being outcomes for families of the intervention group compared to the controls.
CONCLUSIONS: Our research indicates that EMI-Heart is a feasible intervention for infants with CHD after open-heart surgery. The intervention was highly acceptable both to parents and to the paediatric physiotherapist. Online treatment sessions offer a valuable alternative to home and hospital visits. This feasibility RCT provides a foundation for a future full trial.
BACKGROUND: ClinicalTrials.gov, NCTT04666857. Registered 23.11.2020.