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经颅直流电刺激(tDCS)联合行走训练对帕金森病患者行走、活动能力和跌倒减少的影响:一项随机临床试验的研究方案。

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.

机构信息

Center of Health Sciences, Discipline of Physical Therapy, Universidade Federal do Espírito Santo (UFES), 1468 Marechal Campos Avenue, Maruípe, Vitória, ES, 29043900, Brazil.

NeuroGroup, Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil.

出版信息

Trials. 2021 Sep 21;22(1):647. doi: 10.1186/s13063-021-05603-z.

Abstract

BACKGROUND

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.

METHODS

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).

DISCUSSION

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.

TRIAL REGISTRATION

Brazilian Registry of Clinical Trials (ReBEC) RBR-6bvnx6 . Registered on September 23, 2019.

摘要

背景

经颅直流电刺激(tDCS)具有调节皮质兴奋性的潜力,并能增强帕金森病患者行走训练的效果。本研究将考察 tDCS 联合特定任务行走训练对改善帕金森病患者行走和移动能力、减少跌倒的疗效。

方法

这是一项双臂、前瞻性注册、随机试验,采用隐匿分组、盲法评估员、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,分为慢走或中速行走者(行走速度≤1.0 m/s)。实验组将接受 30 分钟与 tDCS 相关的行走训练,持续 4 周。对照组将接受相同的行走训练,但采用假 tDCS。主要结局将是舒适行走速度。次要结局将包括行走步长、行走步频、行走信心、移动能力、步态冻结、跌倒恐惧和跌倒。在基线(第 0 周)、干预后(第 4 周)和干预后 1 个月(第 8 周),将由对分组分配不知情的研究人员收集结果。

讨论

与行走训练相关的 tDCS 可能有助于改善帕金森病慢走和中速行走者的行走能力。如果行走能力得到改善,可能会伴随着更好的移动能力和降低的跌倒恐惧,并且患者可能会在家中和社区中体验到更多的自由活动的体力活动。

试验注册

巴西临床试验注册处(ReBEC)RBR-6bvnx6。于 2019 年 9 月 23 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ff1/8454107/39e2642c8221/13063_2021_5603_Fig1_HTML.jpg

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