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register hereBackground: Gross motor function impairments and manual dexterity deficits are frequently observed in children and adolescents with Cerebral Palsy (CP), having a major impact on their activity level and autonomy. Improving manual dexterity and activity level of patients with CP is often the focus of rehabilitation.
背景:脑瘫(CP)儿童和青少年经常观察到粗大运动功能障碍和手动灵活性缺陷,对他们的活动水平和自主性产生重大影响。提高CP患者的手动灵活性和活动水平通常是康复的重点。
Novel and adjuvant treatment methods that could support the standard training also in chronic conditions are a research priority. The transcutaneous Vagus Nerve Stimulation (tVNS) is a non-invasive brain stimulation technique which provides a bottom-up stimulation of subcortical and cortical brain structures, enhancing brain GABA and Noradrenaline levels.
在慢性病中也可以支持标准训练的新型辅助治疗方法是研究的重点。经皮迷走神经刺激(tVNS)是一种非侵入性脑刺激技术,可自下而上刺激皮层下和皮层脑结构,增强大脑GABA和去甲肾上腺素水平。
This technique may play a pivotal role in brain plasticity, which has not been tested in CP patients before.Method: 44 children and adolescents with CP will be involved, treated in pairs in a randomized, double-blind, pre-post test study. The two groups will undergo the Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for two consecutive weeks, with 3h daily sessions for five days per week, for an overall time interval of 30 hours; the training will be combined with the application for 75 minutes/day of active or sham tVNS, in separate, randomly allocated groups.
这项技术可能在大脑可塑性中发挥关键作用,这之前尚未在CP患者中进行过测试。方法:将44名患有CP的儿童和青少年纳入随机,双盲,前后测试研究。两组将连续两周接受包括下肢(习惯-ILE)在内的双手强化治疗,每天3小时,每周5天,总时间间隔为30小时;培训将与每天75分钟的活动或假tVNS的申请相结合,分为单独的随机分组。
The primary outcome measure will include the scores at the Assisting Hand Assessment and Box and Block Test, and at an ad-hoc visuomotor task evaluating manual visuomotor control. Secondary outcomes will include the scores at the Children's Hand Experience Questionnaire, Canadian Occupational Performance Measure, Melbourne Assessment of Unilateral Upper Limb Function, Gross Motor Function Measure, Vineland, Pediatric quality of life inventory.
主要结果指标将包括辅助手评估和框块测试的分数,以及评估手动视觉运动控制的临时视觉运动任务的分数。次要结果将包括儿童手部经验问卷,加拿大职业表现测量,墨尔本单侧上肢功能评估,粗大运动功能测量,Vineland,儿科生活质量量表的得分。
The evaluation points will include pre (T0), post (T1) and .
评估点包括前(T0)、后(T1)和。