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最大耐受每日剂量的镜像运动疗法踝关节运动治疗卒中后患者:一项早期剂量筛选研究。

Maximum tolerable daily dose of mirror movement therapy ankle exercises after stroke: an early phase dose screening study.

机构信息

University of East Anglia, UK.

出版信息

Physiotherapy. 2024 Mar;122:30-39. doi: 10.1016/j.physio.2023.10.007. Epub 2023 Nov 4.

DOI:10.1016/j.physio.2023.10.007
PMID:38237263
Abstract

BACKGROUND

Mirror movement therapy may reduce lower limb motor impairment after stroke. The dose is unknown.

OBJECTIVE

identify the maximum tolerable dose a day (MTD) of lower limb mirror movement therapy DESIGN: 3 + 3 cohort rule-based, dose escalation/de-escalation study. After undertaking baseline measures participants performed mirror movement therapy for 14 consecutive days. Participants then undertook outcome measures. Cohort One trained for 15 minutes daily. Subsequent cohorts exercised at a dose set according to pre-set rules and the modified Fibonacci sequence. The study stopped when the difference between set doses for consecutive cohorts was 10% or less.

SETTING

Participants' homes (intervention) and a movement analysis laboratory (measures).

PARTICIPANTS

Adults discharged from statutory stroke rehabilitation services.

INTERVENTION

Mirror movement therapy ankle exercises.

OUTCOME MEASURES

Motricity Index (primary) and bilateral time symmetry from movement onset to peak activation of Tibialis Anterior muscles during standardised sit-to-stand (secondary).

RESULTS

Five cohorts of three participants were included (n = 15). Mean (SD) age and time after stroke were 61 (9) years and 35 (42) months respectively. Set daily doses for the five cohorts were: 15, 30, 50, 40 then 35 minutes. The set dose for a subsequent cohort (six) would have been 38 minutes thus the difference from cohort five would have been three minutes i.e., 9% different. Therefore, the study stopped CONCLUSION: The identified MTD of lower limb mirror therapy was 35 minutes daily when frequency was set at seven days a week and duration as two weeks.

CLINICAL TRIAL REGISTRATION NUMBER

NCT04339803 (ClinicalTrials.gov) CONTRIBUTION OF THE PAPER: This early phase study found that the maximum tolerable dose per day (MTD) of mirror movement therapy ankle exercises was 35 minutes when frequency was set at seven days a week and duration as two weeks. The optimal therapeutic dose will therefore be somewhere in the range of 15 (starting dose) to 35 minutes per day. Further dose articulation studies are required to identify the optimal therapeutic dose before use of findings in clinical practice. This study is the first step in that research process.

摘要

背景

镜像运动疗法可能会减少中风后下肢运动障碍。剂量未知。

目的

确定下肢镜像运动疗法的每日最大耐受剂量(MTD)。

设计

基于 3+3 队列规则的剂量递增/递减研究。在进行基线测量后,参与者连续 14 天进行镜像运动治疗。然后,参与者进行结果测量。第一组每天训练 15 分钟。随后的组根据预设规则和修改后的斐波那契序列以设定的剂量进行锻炼。当连续组的设定剂量之间的差异为 10%或更小时,研究停止。

地点

参与者的家庭(干预)和运动分析实验室(措施)。

参与者

从法定中风康复服务中出院的成年人。

干预

镜像运动疗法踝关节运动。

结果

共纳入五组三组参与者(n=15)。平均(SD)年龄和中风后时间分别为 61(9)岁和 35(42)个月。五个队列的每日设定剂量分别为:15、30、50、40 和 35 分钟。第六个后续队列的设定剂量为 38 分钟,因此与第五个队列的差值为 3 分钟,即相差 9%。因此,研究停止。

结论

当每周设定 7 天、持续 2 周时,下肢镜像治疗的确定 MTD 为每天 35 分钟。

临床试验注册号

NCT04339803(ClinicalTrials.gov)

论文的贡献

这项早期阶段的研究发现,当每周设定 7 天、持续 2 周时,镜像运动疗法踝关节运动的每日最大耐受剂量(MTD)为 35 分钟。因此,最佳治疗剂量将在每天 15(起始剂量)至 35 分钟之间。需要进一步进行剂量阐述研究,以确定在临床实践中使用研究结果之前的最佳治疗剂量。这项研究是该研究过程的第一步。

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