额外躯干训练对步态表现的有效性：一项随机对照试验的研究方案
Effectiveness of additional trunk exercises on gait performance: study protocol for a randomized controlled trial.
作者信息
Van Criekinge Tamaya, Saeys Wim, Hallemans Ann, Vereeck Luc, De Hertogh Willem, Van de Walle Patricia, Vaes Nathalie, Lafosse Christophe, Truijen Steven
机构信息
Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, 2610, Antwerp, Belgium.
KU Leuven Department of Psychology, University of Leuven, Leuven, Belgium.
出版信息
Trials. 2017 Jun 2;18(1):249. doi: 10.1186/s13063-017-1989-1.
BACKGROUND
Evidence is lacking concerning the effect of additional trunk rehabilitation on gait performance. Investigating gait performance by both clinical and biomechanical outcome measures might lead to new scientific insights into the importance of the trunk during gait rehabilitation in people suffering from stroke. This protocol was written according to the SPIRIT 2013 Statement.
METHODS AND DESIGN
An assessor-blinded randomized controlled trial will be conducted in patients with impaired trunk control after stroke. A total of 60 patients will be randomly allocated to the control or the experimental group by means of sealed opaque envelopes. They will receive either 16 h of additional trunk exercises (experimental group) or cognitive exercises (controls) for 1 h a day, 4 days a week for 4 weeks. Patients will also receive 2 h of standard care consisting of physiotherapy and occupational therapy. Gait performance will be assessed clinically by the Tinetti Test and biomechanically by means of a full body gait analysis. In addition, the effect of the exercise protocol on the trunk itself and trunk activities of daily living will be assessed by the Trunk Impairment Scale and the Barthel Index.
DISCUSSION
Despite the evidence demonstrating the importance of trunk control after stroke, studies about the effects of trunk rehabilitation on gait performance are inconsistent. In the current study, a more sophisticated treatment protocol will be used to enlarge therapeutic improvements, the relationship between clinical and biomechanical measures of gait performance can be investigated, and the sustainability of the effects of trunk exercises over time will be examined. Since clinical improvements are of greater importance to patients and physiotherapists, clinical assessment scales will be used as primary outcome measures.
TRIAL REGISTRATION
ClinicalTrials.gov, ID: NCT02708888 . Registered on 2 March 2016.
背景
关于额外的躯干康复对步态表现的影响，目前证据不足。通过临床和生物力学结果指标来研究步态表现，可能会为中风患者步态康复过程中躯干的重要性带来新的科学见解。本方案是根据《渥太华小组方案声明（SPIRIT）2013》编写的。
方法与设计
将对中风后躯干控制受损的患者进行一项评估者盲法随机对照试验。总共60名患者将通过密封不透明信封随机分配至对照组或试验组。他们将接受为期4周、每周4天、每天1小时的干预：试验组进行16小时的额外躯干训练，对照组进行认知训练。患者还将接受由物理治疗和职业治疗组成的2小时标准护理。步态表现将通过Tinetti测试进行临床评估，并通过全身步态分析进行生物力学评估。此外，将通过躯干功能障碍量表和Barthel指数评估训练方案对躯干本身及其日常生活活动的影响。
讨论
尽管有证据表明中风后躯干控制很重要，但关于躯干康复对步态表现影响的研究结果并不一致。在本研究中，将采用更完善的治疗方案以扩大治疗效果，研究步态表现的临床和生物力学指标之间的关系，并检验躯干训练效果随时间的可持续性。由于临床改善对患者和物理治疗师更为重要，因此将使用临床评估量表作为主要结果指标。
试验注册
ClinicalTrials.gov，标识符：NCT02708888。于2016年3月2日注册。
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