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采用照料者介导的锻炼联合远程康复的联合康复治疗用于脑卒中(ARMed4Stroke):一项随机对照试验。

Allied rehabilitation using caregiver-mediated exercises combined with telerehabilitation for stroke (ARMed4Stroke): A randomised controlled trial.

机构信息

Amsterdam Rehabilitation Research Centre, Reade, Amsterdam, the Netherlands.

Department of Rehabilitation Medicine, Amsterdam University Medical Center, VUmc, Amsterdam Movement Sciences, Amsterdam, the Netherlands.

出版信息

Clin Rehabil. 2024 Oct;38(10):1321-1332. doi: 10.1177/02692155241261700. Epub 2024 Aug 1.

Abstract

OBJECTIVE

To assess the added value of caregiver-mediated exercises combined with telerehabilitation in addition to usual care compared to usual care alone on the self-reported mobility outcome after subacute stroke.

DESIGN

Multicentre, observer-blinded, parallel randomised controlled trial. An off-site researcher allocated treatments using minimisation.

SETTING

Four rehabilitation centres in the Netherlands.

PARTICIPANTS

Forty-one patient-caregiver dyads within 3 months poststroke.

INTERVENTION

Eight-week blended care program with caregiver-mediated mobility exercises for 2.5 h per week supported by telerehabilitation and four face-to-face sessions in addition to usual care.

MAIN MEASURES

Self-reported mobility domain of the Stroke Impact Scale postintervention. Secondary outcomes were functional outcome, dyads' psychosocial wellbeing, care transition to the community postintervention and after 6 months.

RESULTS

Forty-one dyads (21 intervention, 20 control) were randomised, and 37 (N = 18; N = 19) were analysed following intention-to-treat. The Stroke Impact Scale mobility was not significantly different between groups postintervention (B 0.8, 95% CI -6.8-8.5, = 0.826). The secondary outcomes, namely, (a) caregivers' quality of life postintervention (= 0.013), (b) caregivers' symptoms of depression postintervention (= 0.025), and (c) independence in leisurely activities at 6 months (= 0.024), showed significant benefits in favour of caregiver-mediated exercises with telerehabilitation. A significant difference favouring controls was found in self-reported muscle strength at 6 months (= 0.002).

CONCLUSIONS

Caregiver-mediated exercises combined with telerehabilitation yielded no differential effect on our primary outcome self-reported mobility. Although the trial is underpowered, current findings are in line with previous trials. Future studies should further explore beneficial effects of caregiver involvement in stroke rehabilitation targeting psychosocial wellbeing.

摘要

目的

评估在常规护理基础上,额外增加照顾者介导的运动结合远程康复治疗对亚急性脑卒中后自我报告的移动能力结局的影响。

设计

多中心、观察者盲法、平行随机对照试验。一位场外研究人员使用最小化方法分配治疗。

地点

荷兰的 4 个康复中心。

参与者

41 对卒中后 3 个月内的患者-照顾者。

干预

8 周的混合护理计划,每周由照顾者进行 2.5 小时的移动锻炼,辅以远程康复和 4 次面对面治疗,在此基础上增加常规护理。

主要测量指标

干预后脑卒中影响量表的自我报告移动能力域。次要结局为功能结局、双元的心理社会健康、干预后和 6 个月时向社区的护理过渡。

结果

41 对患者-照顾者被随机分组,37 对(N=18;N=19)根据意向治疗进行分析。干预后两组间脑卒中影响量表的移动能力无显著差异(B 0.8,95%CI -6.8-8.5, = 0.826)。次要结局,包括(a)干预后照顾者的生活质量( = 0.013),(b)干预后照顾者的抑郁症状( = 0.025),以及(c)6 个月时休闲活动的独立性( = 0.024),都显示出照顾者介导的运动结合远程康复的显著获益。6 个月时自我报告的肌肉力量显示出有利于对照组的显著差异( = 0.002)。

结论

在常规护理基础上,增加照顾者介导的运动结合远程康复对我们的主要结局自我报告的移动能力没有产生差异影响。尽管该试验的效力不足,但目前的结果与之前的试验一致。未来的研究应进一步探索照顾者参与针对心理社会健康的脑卒中康复治疗的有益效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/95d9/11520259/0f947b522e8b/10.1177_02692155241261700-fig1.jpg

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