Remote ischaemic conditioning combined with bimanual task training to enhance bimanual skill learning and corticospinal excitability in children with unilateral cerebral palsy: a study protocol of a single centre, phase II randomised controlled trial.
Remote ischaemic conditioning combined with bimanual task training to enhance bimanual skill learning and corticospinal excitability in children with unilateral cerebral palsy: a study protocol of a single centre, phase II randomised controlled trial.
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DOI：
10.1136/bmjopen-2023-076881
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发表时间：
2023-09-28
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
--
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单侧脑性瘫痪（UCP）儿童双手协调困难，限制了儿童在日常活动中的独立性。虽然存在几种有效的干预措施来改善双手协调，但这些干预措施通常需要更高的训练剂量，并且具有适度的效果。因此，迫切需要找到一种有效的启动剂，当与特定任务的训练配对时，将促进神经生物学过程，以提高训练效果的大小，并随后改善UCP儿童的功能能力。本研究的目的是确定一种新的启动剂，远程缺血性条件反射（RIC），结合双手训练双手技能学习和皮质脊髓兴奋性的儿童UCP的影响。46名8 - 16岁的儿童将被随机分配接受RIC或假条件训练，并接受5天的双手技能（叠杯）训练（每次15次试验）。RIC或假处理将采用标准处理方案进行，即对受影响手臂上的压力袖带进行5个周期的交替充气和放气，RIC的压力至少比收缩压高20 mm Hg，假处理的压力至少比收缩压高25 mm Hg。主要结果将是运动时间和皮质脊髓兴奋性的措施确定与单脉冲经颅磁刺激（TMS）。次要结局包括辅助手评估、时空运动学变量和成对脉冲TMS测量。所有措施都将在干预之前和之后立即进行。混合模型方差分析将检验所有结局的组×时间相互作用，其中组（RIC和假手术）作为受试者间因素，时间（干预前、干预后）作为受试者内因素。该研究已获得大学医学中心机构审查委员会（UMCIB#21 - 001913）的批准。我们将通过同行评审的出版物和专业会议上的演讲来传播研究结果。 NCT05777070
Children with unilateral cerebral palsy (UCP) have difficulty in bimanual coordination that restricts the child’s independence in daily activities. Although several efficacious interventions to improve bimanual coordination exist, these interventions often require higher training doses and have modest effect sizes. Thus, there is a critical need to find an effective priming agent that, when paired with task-specific training, will facilitate neurobiological processes to enhance the magnitude of training effects and subsequently improve functional capabilities of children with UCP. The aim of this study is to determine the effects of a novel priming agent, remote ischaemic conditioning (RIC), combined with bimanual training on bimanual skill learning and corticospinal excitability in children with UCP. 46 children, aged 8–16 years, will be randomly assigned to receive RIC or sham conditioning combined with 5 days of bimanual skill (cup stacking) training (15 trials per session). RIC or sham conditioning will be performed with a standard conditioning protocol of five cycles of alternative inflation and deflation of a pressure cuff on the affected arm with the pressure of at least 20 mm Hg above systolic blood pressure for RIC and 25 mm Hg for sham conditioning. Primary outcomes will be movement time and corticospinal excitability measures determined with a single-pulse transcranial magnetic stimulation (TMS). Secondary outcomes include Assisting Hand Assessment, spatio-temporal kinematic variables and paired pulse TMS measures. All measures will be conducted before and immediately after the intervention. A mixed model analysis of variance will test the group×time interaction for all outcomes with group (RIC and sham) as between-subject and time (preintervention, postintervention) as within-subject factors. The study has been approved by the University Medical Centre Institutional Review Board (UMCIRB #21-001913). We will disseminate the study findings via peer-reviewed publications and presentations at professional conferences. NCT05777070
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影响因子：
3.1
作者：
Bleyenheuft Y;Dricot L;Gilis N;Kuo HC;Grandin C;Bleyenheuft C;Gordon AM;Friel KM
通讯作者：
Friel KM
影响因子：
5.4
作者：
England, Timothy J.;Hedstrom, Amanda;Bath, Philip M.
通讯作者：
Bath, Philip M.
影响因子：
3.1
作者：
Carneiro, Maira I. S.;Russo, Cristina;Bolognini, Nadia
通讯作者：
Bolognini, Nadia
影响因子：
2.6
作者：
Gillick BT;Gordon AM;Feyma T;Krach LE;Carmel J;Rich TL;Bleyenheuft Y;Friel K
通讯作者：
Friel K
影响因子：
3.1
作者：
Inguaggiato E;Sgandurra G;Perazza S;Guzzetta A;Cioni G
通讯作者：
Cioni G