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帕金森病中综合与连续双重任务练习随机比较的方案:二元性试验

Protocol for a randomized comparison of integrated versus consecutive dual task practice in Parkinson's disease: the DUALITY trial.

作者信息

Strouwen Carolien, Molenaar Esther A L M, Keus Samyra H J, Münks Liesbeth, Munneke Marten, Vandenberghe Wim, Bloem Bastiaan R, Nieuwboer Alice

机构信息

Department of Rehabilitation Sciences, KU Leuven, Faculty of Kinesiology and Rehabilitation, Tervuursevest 101 bus 1501, Leuven 3001, Belgium.

出版信息

BMC Neurol. 2014 Mar 27;14:61. doi: 10.1186/1471-2377-14-61.

DOI:10.1186/1471-2377-14-61
PMID:24674594
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3974198/
Abstract

BACKGROUND

Multiple tasking is an integral part of daily mobility. Patients with Parkinson's disease have dual tasking difficulties due to their combined motor and cognitive deficits. Two contrasting physiotherapy interventions have been proposed to alleviate dual tasking difficulties: either to discourage simultaneous execution of dual tasks (consecutive training); or to practice their concurrent use (integrated training). It is currently unclear which of these training methods should be adopted to achieve safe and consolidated dual task performance in daily life. Therefore, the proposed randomized controlled trial will compare the effects of integrated versus consecutive training of dual tasking (tested by combining walking with cognitive exercises).

METHODS AND DESIGN

Hundred and twenty patients with Parkinson's disease will be recruited to participate in this multi-centered, single blind, randomized controlled trial. Patients in Hoehn & Yahr stage II-III, with or without freezing of gait, and who report dual task difficulties will be included. All patients will undergo a six-week control period without intervention after which they will be randomized to integrated or consecutive task practice. Training will consist of standardized walking and cognitive exercises delivered at home four times a week during six weeks. Treatment is guided by a physiotherapist twice a week and consists of two sessions of self-practice using an MP3 player. Blinded testers will assess patients before and after the control period, after the intervention period and after a 12-week follow-up period. The primary outcome measure is dual task gait velocity, i.e. walking combined with a novel untrained cognitive task to evaluate the consolidation of learning. Secondary outcomes include several single and dual task gait and cognitive measures, functional outcomes and a quality of life scale. Falling will be recorded as a possible adverse event using a weekly phone call for the entire study period.

DISCUSSION

This randomized study will evaluate the effectiveness and safety of integrated versus consecutive task training in patients with Parkinson's disease. The study will also highlight whether dual task gait training leads to robust motor learning effects, and whether these can be retained and carried-over to untrained dual tasks and functional mobility.

TRIAL REGISTRATION

Clinicaltrials.gov NCT01375413.

摘要

背景

多任务处理是日常活动中不可或缺的一部分。帕金森病患者由于运动和认知功能的综合缺陷,在进行双重任务时存在困难。目前提出了两种截然不同的物理治疗干预方法来缓解双重任务困难:一种是不鼓励同时执行双重任务(连续训练);另一种是练习同时使用(综合训练)。目前尚不清楚应采用哪种训练方法来在日常生活中实现安全且稳固的双重任务表现。因此,拟进行的随机对照试验将比较双重任务综合训练与连续训练的效果(通过将步行与认知练习相结合进行测试)。

方法与设计

将招募120名帕金森病患者参与这项多中心、单盲、随机对照试验。纳入Hoehn & Yahr分期为II - III期、有或无步态冻结且报告存在双重任务困难的患者。所有患者将接受为期六周的无干预对照期,之后随机分为综合任务练习组或连续任务练习组。训练包括标准化的步行和认知练习,在六周内每周在家进行四次。治疗由物理治疗师每周指导两次,包括使用MP3播放器进行两次自我练习。盲法测试人员将在对照期前后、干预期后以及12周随访期后对患者进行评估。主要结局指标是双重任务步态速度,即步行与一项新的未经训练的认知任务相结合,以评估学习的巩固情况。次要结局包括多项单任务和双重任务步态及认知指标、功能结局和生活质量量表。在整个研究期间,通过每周电话随访记录跌倒这一可能的不良事件。

讨论

这项随机研究将评估帕金森病患者综合任务训练与连续任务训练的有效性和安全性。该研究还将突出双重任务步态训练是否会产生强大的运动学习效果,以及这些效果是否能够保持并推广到未经训练的双重任务和功能活动中。

试验注册

Clinicaltrials.gov NCT01375413。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/830e/3974198/657600b732f7/1471-2377-14-61-3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/830e/3974198/16d4d3ae982e/1471-2377-14-61-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/830e/3974198/f0472d56f7fa/1471-2377-14-61-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/830e/3974198/657600b732f7/1471-2377-14-61-3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/830e/3974198/16d4d3ae982e/1471-2377-14-61-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/830e/3974198/f0472d56f7fa/1471-2377-14-61-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/830e/3974198/657600b732f7/1471-2377-14-61-3.jpg

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