Faculdade de Medicina da Universidade Federal de Minas Gerais, Federal University of Minas Gerais, Belo Horizonte, Brazil.
Instituto Nacional de Ciência e Tecnologia de Medicina Molecular, Universidade Federal de Minas Gerais, Belo Horinzote, Brazil.
JMIR Res Protoc. 2024 Apr 30;13:e52922. doi: 10.2196/52922.
BACKGROUND: Children diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily living. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that has been used to improve movement, gross motor function, and activities of daily living. OBJECTIVE: This study aims to evaluate the potential additional effects of physiotherapy combined with tDCS in children with CP in comparison with physiotherapy only. METHODS: This is a 2-arm randomized controlled trial that will compare the effects of tDCS as an adjunctive treatment during rehabilitation sessions to rehabilitation without tDCS. Children with CP classified by the Gross Motor Function Classification System as levels I and II will be randomly assigned to either the sham + rehabilitation group or the tDCS + rehabilitation group. The primary outcome will be the motor skills assessed using the Gross Motor Function Measure domain E scores, and the secondary outcome will be the measurement scores of the children's quality of life. The intervention will consist of a 10-day stimulation protocol with tDCS spread over 2 weeks, with stimulation or sham tDCS administered for 20 minutes at a frequency of 1 Hz, in combination with physiotherapy. Physical therapy exercises will be conducted in a circuit based on each child's baseline Gross Motor Function Measure results. The participants' changes will be evaluated and compared in both groups. Intervenient features will be tested. RESULTS: Data collection is ongoing and is expected to be completed by January 2025. A homogeneous sample and clear outcomes may be a highlight of this protocol, which may allow us to understand the potential use of tDCS and for whom it should or should not be used. CONCLUSIONS: A study with good evidence and clear outcomes in children with CP might open an avenue for the potential best use of neurostimulation. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials RBR-104h4s4y; https://tinyurl.com/47r3x2e4. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/52922.
背景:患有脑瘫(CP)的儿童通常会经历各种功能障碍,尤其是在粗大运动功能和日常生活活动方面。经颅直流电刺激(tDCS)是一种非侵入性脑刺激技术,已被用于改善运动、粗大运动功能和日常生活活动。
目的:本研究旨在评估与单纯物理治疗相比,tDCS 联合物理治疗对 CP 儿童的潜在附加作用。
方法:这是一项双臂随机对照试验,将比较 tDCS 作为康复治疗期间辅助治疗与不进行 tDCS 的康复治疗的效果。根据粗大运动功能分类系统分类为 I 级和 II 级的 CP 儿童将被随机分配到假刺激+康复组或 tDCS+康复组。主要结局将是使用粗大运动功能测量领域 E 评分评估的运动技能,次要结局将是儿童生活质量的测量评分。干预将包括为期 10 天的 tDCS 刺激方案,在 2 周内分布,以 1 Hz 的频率进行 20 分钟的刺激或假刺激 tDCS,与物理治疗相结合。物理治疗运动将根据每个孩子的基线粗大运动功能测量结果进行基于电路的进行。将评估和比较两组参与者的变化。将测试干预措施的特点。
结果:数据收集正在进行中,预计将于 2025 年 1 月完成。本方案的一个亮点可能是样本均匀且结局明确,这可能使我们能够了解 tDCS 的潜在用途以及应该或不应该用于谁。
结论:一项在 CP 儿童中具有良好证据和明确结局的研究可能为神经刺激的潜在最佳用途开辟途径。
试验注册:巴西临床试验注册处 RBR-104h4s4y;https://tinyurl.com/47r3x2e4。
国际注册报告标识符(IRRID):PRR1-10.2196/52922。
Cochrane Database Syst Rev. 2017-6-11
Cochrane Database Syst Rev. 2024-5-29
Cochrane Database Syst Rev. 2016-7-18
Cochrane Database Syst Rev. 2011-12-7
Cochrane Database Syst Rev. 2018-3-16
Cochrane Database Syst Rev. 2015-11-13
Neuropsychiatr Dis Treat. 2020-6-12
Am Fam Physician. 2020-2-15
Cochrane Database Syst Rev. 2019-10-3
J Biomed Inform. 2019-5-9
Eur J Phys Rehabil Med. 2016-10