Health Sciences North, Sudbury, Ontario, Canada.
Faculty of Education and Health, School of Kinesiology and Health Sciences, Laurentian University, Sudbury, Ontario, Canada.
Trials. 2021 Jul 9;22(1):439. doi: 10.1186/s13063-021-05380-9.
Many therapeutic interventions are performed by physiotherapists to improve upper extremity function and/or activities of daily living (ADL) in stroke patients. Mirror therapy (MT) is a simple technique that can be self-administered by the patients with intact cognition following patient education by a skilled physiotherapist. However, the effectiveness of self-administered MT in post-stroke patients in upper extremity function remains unclear. Therefore, the objective of this study is to examine the effectiveness of MT in improving upper extremity function and recovery in acute stroke patients.
This study is a single-center, prospective, randomized, open-label, controlled trial with blinded outcome evaluation (PROBE design), in which a total of 36 eligible acute stroke patients will be randomly assigned to control (n=18) and experimental group (n=18). Participants in the control group will receive regular rehabilitation interventions whereas participants in the experimental group will receive MT education in addition to their regular interventions for 4 weeks.
The primary outcome measure will be upper extremity function that will be measured using the Fugl-Meyer Assessment scale and the Wolf Motor Function Test. The secondary outcome measure will be behaviors related to ADL as estimated using the Modified Barthel Index. Outcome measures will be assessed at baseline and at 4 weeks post-rehabilitation intervention/MT.
A two-way repeated analysis of variance (ANOVA) with time and group effects will be used to analyze between-group differences. The level of significance will be set at P < 0.05.
The results of the study will provide critical information to include self-administered MT as an adjuvant to regular interventions and may facilitate recovery of the upper extremity function of stroke patients.
ClinicalTrials.gov NCT04542772 . Registered on 9 September 2020. Protocol version: Final 1.0.
许多治疗干预措施都是由物理治疗师进行的，以改善脑卒中患者的上肢功能和/或日常生活活动（ADL）。镜像疗法（MT）是一种简单的技术，患者在认知完整的情况下，经过有经验的物理治疗师的患者教育，就可以自行进行。然而，MT 对脑卒中后患者上肢功能的自我管理效果尚不清楚。因此，本研究的目的是检验 MT 在改善急性脑卒中患者上肢功能和康复方面的效果。
这是一项单中心、前瞻性、随机、开放标签、对照试验（PROBE 设计），共纳入 36 名符合条件的急性脑卒中患者，随机分为对照组（n=18）和实验组（n=18）。对照组患者将接受常规康复干预，而实验组患者将在常规干预的基础上接受 MT 教育，为期 4 周。
主要结局测量指标是上肢功能，将使用 Fugl-Meyer 评估量表和 Wolf 运动功能测试进行测量。次要结局测量指标是 ADL 相关行为，将使用改良巴氏指数进行评估。在基线和康复干预/MT 后 4 周时评估结局测量指标。
将采用双向重复方差分析（ANOVA）进行组间差异分析，考虑时间和组别的影响。显著性水平设为 P < 0.05。
该研究的结果将提供关键信息，将自我管理的 MT 作为常规干预的辅助手段，可能有助于脑卒中患者上肢功能的恢复。
ClinicalTrials.gov NCT04542772。于 2020 年 9 月 9 日注册。方案版本：最终 1.0 版。
Zotero 插件