Study protocol for a randomised controlled trial to determine the efficacy of an intensive seated postural intervention delivered with robotic and rigid trunk support systems.
Study protocol for a randomised controlled trial to determine the efficacy of an intensive seated postural intervention delivered with robotic and rigid trunk support systems.
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DOI：
10.1136/bmjopen-2023-073166
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发表时间：
2023-08-17
期刊：
影响因子：
2.9
通讯作者：
Agrawal, Sunil K.
中科院分区：
文献类型：
--
作者：
Santamaria, Victor;Ai, Xupeng;Chin, Karen;Dutkowsky, Joseph P.;Gordon, Andrew M.;Agrawal, Sunil K.
被归类为粗大运动功能分类系统 (GMFCS) III-IV 级的脑瘫 (CP) 儿童表现出坐姿和伸手控制能力受损，从而妨碍了他们的整体功能表现。然而，改善与坐相关的活动的有效干预措施却很少。我们最近设计了一种基于运动学习的干预措施，通过机器人躯干支撑训练器（TruST 干预）提供，其中我们应用力场技术来个性化坐姿平衡支持。我们提出了一项随机对照试验，以测试机器人 TruST 与静态躯干支撑系统相比的运动干预效果。我们将招募 82 名 CP、GMFCS III-IV、年龄 6-17 岁的参与者。将使用与研究无关的人准备的不透明密封信封对 TruST 支持或静态躯干支持干预进行隐藏分配的随机化。我们将应用意向治疗方案。干预措施包括每次 2 小时、每周 3 次、持续 4 周。参与者将通过骨盆捆扎开始这两种干预措施。在 TruST 干预中，姿势任务进展将通过逐渐增加力场边界然后移除骨盆带来实现。在静态躯干支撑干预中，我们将逐渐降低躯干支撑并拆除骨盆绑带。将在基线、训练中点、干预后 1 周和 3 个月随访时评估结果。主要结果将包括修改后的功能范围测试、坐姿工作空间的运动学评估以及盒子和块测试。次要结果将包括躯干控制测试的分段评估、坐姿姿势和伸展控制测试、粗大运动功能测量项目集、加拿大职业绩效结果、参与和环境测量和青少年，以及姿势和伸展运动学。该研究得到了哥伦比亚大学机构审查委员会 (AAAS7804) 的批准。这项研究由美国国立卫生研究院 (1R01HD101903-01) 资助，并在 ClinicalTrials.gov 上注册。 NCT04897347；临床试验.gov。
Children with cerebral palsy (CP) classified as gross motor function classification system (GMFCS) levels III–IV demonstrate impaired sitting and reaching control abilities that hamper their overall functional performance. Yet, efficacious interventions for improving sitting-related activities are scarce. We recently designed a motor learning-based intervention delivered with a robotic Trunk-Support-Trainer (TruST-intervention), in which we apply force field technology to individualise sitting balance support. We propose a randomised controlled trial to test the efficacy of the motor intervention delivered with robotic TruST compared with a static trunk support system. We will recruit 82 participants with CP, GMFCS III–IV, and aged 6–17 years. Randomisation using concealed allocation to either the TruST-support or static trunk-support intervention will be conducted using opaque-sealed envelopes prepared by someone unrelated to the study. We will apply an intention-to-treat protocol. The interventions will consist of 2 hours/sessions, 3/week, for 4 weeks. Participants will start both interventions with pelvic strapping. In the TruST-intervention, postural task progression will be implemented by a progressive increase of the force field boundaries and then by removing the pelvic straps. In the static trunk support-intervention, we will progressively lower the trunk support and remove pelvic strapping. Outcomes will be assessed at baseline, training midpoint, 1-week postintervention, and 3-month follow-up. Primary outcomes will include the modified functional reach test, a kinematic evaluation of sitting workspace, and the Box and Block test. Secondary outcomes will include The Segmental Assessment of Trunk Control test, Seated Postural & Reaching Control test, Gross Motor Function Measure-Item Set, Canadian Occupational Performance Outcome, The Participation and Environment Measure and Youth, and postural and reaching kinematics. The study was approved by the Columbia University Institutional Review Board (AAAS7804). This study is funded by the National Institutes of Health (1R01HD101903-01) and is registered at clinicaltrials.gov. NCT04897347; clinicaltrials.gov.
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DOI：
10.1161/circoutcomes.114.001381
发表时间：
2015-03-01
影响因子：
6.9
作者：
Abell, Bridget;Glasziou, Paul;Hoffmann, Tammy
通讯作者：
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影响因子：
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作者：
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DOI：
10.1111/j.1469-8749.2011.04094.x
发表时间：
2011-11-01
影响因子：
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作者：
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Kao, Ying-Chia
影响因子：
120.7
作者：
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影响因子：
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作者：
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