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一项单臂介入性研究方案,评估基于家庭的操纵杆式骑乘玩具导航训练计划对改善单侧脑瘫(UCP)儿童受影响上肢功能和自发性使用的效果。

A protocol for a single-arm interventional study assessing the effects of a home-based joystick-operated ride-on-toy navigation training programme to improve affected upper extremity function and spontaneous use in children with unilateral cerebral palsy (UCP).

机构信息

Department of Kinesiology, University of Connecticut, Storrs, Connecticut, USA.

The Institute for the Brain and Cognitive Sciences (IBACS), University of Connecticut, Storrs, Connecticut, USA.

出版信息

BMJ Open. 2023 May 9;13(5):e071742. doi: 10.1136/bmjopen-2023-071742.

DOI:10.1136/bmjopen-2023-071742
PMID:37160396
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10173997/
Abstract

INTRODUCTION

Children with unilateral cerebral palsy (UCP) face significant limitations in upper extremity (UE) function and require effective interventions that promote intensive goal-directed practice while maximising motivation and adherence with therapy. This study builds on our past work and will assess the effects of a 6-week researcher-caregiver codelivered, home-based ride-on-toy navigation training (RNT) programme in young children with UCP. We hypothesise that the RNT programme will be acceptable, feasible to implement, and lead to greater improvements in unimanual and bimanual function when combined with conventional therapy, compared with conventional therapy provided alone.

METHODS AND ANALYSIS

15 children with UCP between 3 and 8 years will be recruited. During the 6-week control phase, participants will receive treatement-as-usual alone. During the subsequent 6-week intervention phase, in addition to conventional therapy, RNT will be provided 4-5 times/week (2 times by researchers, 2-3 times by caregivers), 30-45 min/session. We will assess UE function using standardised tests (Quality of Upper Extremity Skills Test and Shriner's Hospital Upper Extremity Evaluation), reaching kinematics, wrist-worn accelerometry, caregiver-rated ABILHAND-Kids questionnaire, and training-specific measures of movement control during RNT. Programme feasibility and acceptance will be assessed using device use metrics, child and caregiver exit questionnaires, training-specific measures of child engagement, and the Physical Activity Enjoyment Scale. All assessments will be conducted at pretest, following the control phase (midpoint), and after completion of the intervention phase (post-test).

ETHICS AND DISSEMINATION

The study is approved by the Institutional Review Board of the University of Connecticut (# H22-0059). Results from this study will be disseminated through peer-reviewed manuscripts in scientific journals in the field, through national and international conferences, and through presentations to parent advocacy groups and other support organisations associated with CP.

TRIAL REGISTRATION NUMBER

NCT05559320.

摘要

简介

患有单侧脑瘫(UCP)的儿童上肢(UE)功能受限明显,需要有效的干预措施,在最大限度地提高治疗动机和依从性的同时,促进有针对性的密集目标练习。本研究基于我们过去的工作,将评估 6 周研究员-照顾者共同提供的家庭骑乘玩具导航训练(RNT)方案对患有 UCP 的幼儿的影响。我们假设与单独提供传统疗法相比,RNT 方案将具有可接受性、可行性并且在结合传统疗法后可导致单手和双手功能的更大改善。

方法和分析

将招募 15 名 3 至 8 岁的 UCP 儿童。在 6 周的对照阶段,参与者将仅接受常规治疗。在随后的 6 周干预阶段,除了传统疗法外,RNT 将每周提供 4-5 次(研究人员 2 次,照顾者 2-3 次),每次 30-45 分钟/次。我们将使用标准化测试(上肢技能测试质量和 Shriners 医院上肢评估)、达到运动学、手腕佩戴加速度计、照顾者评定的 ABILHAND-Kids 问卷以及 RNT 中运动控制的特定训练措施来评估 UE 功能。将使用设备使用指标、儿童和照顾者退出问卷、儿童参与度的特定训练措施以及身体活动享受量表来评估方案的可行性和可接受性。所有评估将在预测试、对照阶段(中点)后以及干预阶段完成后(后测试)进行。

伦理和传播

该研究已获得康涅狄格大学机构审查委员会的批准(#H22-0059)。本研究的结果将通过科学期刊上的同行评审论文、全国和国际会议以及向 CP 相关的家长倡导团体和其他支持组织的演讲进行传播。

试验注册号

NCT05559320。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/222e/10173997/c6983605303a/bmjopen-2023-071742f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/222e/10173997/c6983605303a/bmjopen-2023-071742f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/222e/10173997/c6983605303a/bmjopen-2023-071742f01.jpg

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