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新型头和躯干控制康复(HATCoRe)设备对脑瘫儿童的影响:单受试者多基线方案。

The effect of novel Head and Trunk Control Rehabilitation (HATCoRe) device in children with cerebral palsy: Single-Subject multiple baseline protocol.

作者信息

Shakya Shristi, Gopalakrishnan Sivakumar, Anaby Dana, Madapura S Shamanth, Shetty Harikishan Balakrishna, Shah Hitesh Hasmukhlal, Venkatesan V S, Rao Bhamini Krishna

机构信息

Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka 576104, India.

Department of Physiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka 576104, India.

出版信息

MethodsX. 2024 Mar 7;12:102649. doi: 10.1016/j.mex.2024.102649. eCollection 2024 Jun.

Abstract

OBJECTIVE

Head and trunk control is essential for enhancing engagement and participation by improving visual integration, respiration, oromotor skill, arm control, and self-care. Our study protocol aims to investigate the effect of novel Head And Trunk Control Rehabilitation (HATCoRe) device on promoting head and trunk control in children with Cerebral Palsy (CP).

METHOD

This single subject multiple baseline design trial will include six children with CP aged two to 10 years, exhibiting delayed head and trunk control, having Gross Motor Function Classification System level IV and V will be enrolled. Participants will be randomly assigned to 4-, 6-, or 8-weeks baseline phases followed by 16-week intervention phase with HATCoRe device, for 30-45 min thrice weekly; and follow-up phase of 9 weeks. The study will span for 29 to 33 weeks. An experienced pediatric physiotherapist, blinded to the baseline duration, will assess the outcome measures through 15 to 19 observations. Structured visual analysis will be used supplemented with the celeration line approach to detect statistically significant change.

IMPACT

HATCoRe device can enable health-care professionals to objectively measure head movement trajectories in children with CP. If proven effective, clinicians may utilize this device to create interactive and child engaging sessions.

摘要

目的

头部和躯干控制对于通过改善视觉整合、呼吸、口部运动技能、手臂控制和自我护理来增强参与度和参与至关重要。我们的研究方案旨在调查新型头部和躯干控制康复(HATCoRe)设备对促进脑瘫(CP)儿童头部和躯干控制的效果。

方法

这项单受试者多基线设计试验将纳入六名年龄在2至10岁之间的CP儿童,这些儿童表现出头部和躯干控制延迟,粗大运动功能分类系统为IV级和V级。参与者将被随机分配到4周、6周或8周的基线阶段,随后是使用HATCoRe设备进行16周的干预阶段,每周三次,每次30至45分钟;以及为期9周的随访阶段。该研究将持续29至33周。一名对基线持续时间不知情的经验丰富的儿科物理治疗师将通过15至19次观察来评估结果指标。将使用结构化视觉分析并辅以加速度线方法来检测具有统计学意义的变化。

影响

HATCoRe设备能够使医疗保健专业人员客观地测量CP儿童的头部运动轨迹。如果被证明有效,临床医生可以利用该设备开展互动性强且能吸引儿童参与的治疗课程。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e212/11647776/ddbd4556bc0f/ga1.jpg

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