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节拍器是否能提高帕金森病患者的生活质量?一项实用主义、单盲、随机交叉试验。

Do metronomes improve the quality of life in people with Parkinson's disease? A pragmatic, single-blind, randomized cross-over trial.

机构信息

Peninsula Technology Assessment Group, Peninsula Medical School, University of Exeter, UK.

出版信息

Clin Rehabil. 2010 Jun;24(6):523-32. doi: 10.1177/0269215509360646. Epub 2010 May 18.

Abstract

OBJECTIVE

To evaluate the effect of acoustic cueing using metronomes on the quality of life of people with moderate to severe Parkinson's disease.

STUDY DESIGN

Pragmatic, single-blind, randomized cross-over trial.

PARTICIPANTS

Forty-two people aged 50-85 years, in Hoehn and Yahr stage II-IV and on stable medication. Eight were lost to follow-up.

INTERVENTION

Participants were randomized using concealed allocation to either an early group (n = 21) to receive an electronic metronome without therapy but limited support (5-10 minutes instruction and on-demand telephone assistance) for four weeks, or a late group (n = 21) to receive the same intervention at 10 weeks. In both groups the beat frequency was initially set to be comfortable for walking.

OUTCOMES MEASURES

Primary and secondary outcomes were measured at baseline, 4, 10 and 14 weeks using the Parkinson's Disease Questionnaire 39 (PDQ-39), the Short Form 36 version 2 (SF-36 version 2) and a falls diary.

RESULTS

There were positive effects in six domains of the SF-36 version 2 and eight domains of the PDQ-39, although only one mean difference was clinically important: the role limitation (emotional) domain of SF-36 version 2 (a mean difference of 3.77, 95% confidence interval (CI), -2.68 to 10.22), a secondary outcome. None of these changes were statistically significant. There were no statistically significant differences in falls rates over the study period. Ten participants (24%) wanted to continue with their metronomes at the end of the study.

CONCLUSION

To demonstrate metronomes are beneficial on the role limitation domain of the SF-36 version 2 in people with moderate to severe Parkinson's disease a sample size of 600 would be required.

摘要

目的

评估节拍器的声学提示对中重度帕金森病患者生活质量的影响。

研究设计

实用、单盲、随机交叉试验。

参与者

42 名年龄在 50-85 岁、处于 Hoehn 和 Yahr 分期 II-IV 期且药物稳定的患者。8 人失访。

干预措施

参与者采用隐匿分组随机分为早期组(n=21)和晚期组(n=21)。早期组先接受电子节拍器,但无治疗,仅提供 5-10 分钟的指导和按需电话协助,为期四周;晚期组则在 10 周时接受相同干预。两组的节拍频率最初设定为步行时舒适的频率。

结局测量

主要和次要结局分别在基线、4、10 和 14 周时使用帕金森病问卷 39(PDQ-39)、健康调查简表 36 版(SF-36 版 2)和跌倒日记进行测量。

结果

SF-36 版 2 的 6 个领域和 PDQ-39 的 8 个领域均有积极影响,但仅有 1 项平均差异具有临床意义:SF-36 版 2 的角色限制(情感)领域(平均差异为 3.77,95%置信区间(CI)为-2.68 至 10.22),为次要结局。这些变化均无统计学意义。研究期间的跌倒率无统计学差异。10 名参与者(24%)在研究结束时希望继续使用节拍器。

结论

要证明节拍器对中重度帕金森病患者 SF-36 版 2 的角色限制领域有获益,需要 600 名参与者的样本量。

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