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Transcranial direct current stimulation (tDCS) in addition to walking training on walking, mobility, and reduction of falls in Parkinson’s disease: study protocol for a randomized clinical trial
Trials ( IF 2.0 ) Pub Date : 2021-09-21 , DOI: 10.1186/s13063-021-05603-z
Lucas Rodrigues Nascimento 1, 2 , Ester Miyuki Nakamura-Palacios 3 , Augusto Boening 1 , Bárbara Naeme Lima Cordeiro 1 , Daniel Lyrio Cabral 1 , Alessandra Swarowsky 4, 5 , Guilherme Peixoto Tinoco Arêas 6 , Wellingson Silva Paiva 7 , Fernando Zanela da Silva Arêas 1, 3
Affiliation  

Transcranial direct current stimulation (tDCS) has the potential to modulate cortical excitability and enhance the effects of walking training in people with Parkinson’s disease. This study will examine the efficacy of the addition of tDCS to a task-specific walking training to improve walking and mobility and to reduce falls in people with Parkinson’s disease. This is a two-arm, prospectively registered, randomized trial with concealed allocation, blinded assessors, participants and therapists, and intention-to-treat analysis. Twenty-four individuals with Parkinson’s disease, categorized as slow or intermediate walkers (walking speeds ≤ 1.0 m/s), will be recruited. The experimental group will undertake a 30-min walking training associated with tDCS, for 4 weeks. The control group will undertake the same walking training, but with sham-tDCS. The primary outcome will be comfortable walking speed. Secondary outcomes will include walking step length, walking cadence, walking confidence, mobility, freezing of gait, fear of falling, and falls. Outcomes will be collected by a researcher blinded to group allocation at baseline (week 0), after intervention (week 4), and 1 month beyond intervention (week 8). tDCS associated with walking training may help improve walking of slow and intermediate walkers with Parkinson’s disease. If walking is enhanced, the benefits may be accompanied by better mobility and reduced fear of falling, and individuals may experience greater free-living physical activity at home and in the community. Brazilian Registry of Clinical Trials (ReBEC) RBR-6bvnx6 . Registered on September 23, 2019

中文翻译:


经颅直流电刺激(tDCS)加上步行训练对帕金森病的步行、活动能力和减少跌倒的影响:随机临床试验的研究方案



经颅直流电刺激 (tDCS) 具有调节皮质兴奋性并增强帕金森病患者步行训练效果的潜力。这项研究将检验在特定任务步行训练中添加经颅直流电刺激 (tDCS) 的效果,以改善帕金森病患者的步行和活动能力并减少跌倒。这是一项双组、前瞻性注册、随机试验,采用隐藏分配、盲法评估者、参与者和治疗师以及意向治疗分析。将招募 24 名帕金森病患者,分为慢速或中速步行者(步行速度 ≤ 1.0 m/s)。实验组将进行 30 分钟与 tDCS 相关的步行训练,为期 4 周。对照组将进行相同的步行训练,但使用假 tDCS。主要结果是舒适的步行速度。次要结果包括步行步长、步行节奏、步行信心、活动能力、步态冻结、对跌倒的恐惧和跌倒。结果将由对分组分配不知情的研究人员在基线(第 0 周)、干预后(第 4 周)和干预后 1 个月(第 8 周)收集结果。与步行训练相关的 tDCS 可能有助于改善患有帕金森病的慢速和中速步行者的步行。如果步行得到加强,好处可能会伴随着更好的活动能力和减少对跌倒的恐惧,并且个人可能会在家里和社区中体验到更多的自由生活身体活动。巴西临床试验注册处 (ReBEC) RBR-6bvnx6 。 2019年9月23日注册
更新日期:2021-09-21
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