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.
METHODS: Multicentre, observer-blinded, parallel randomised controlled trial. An off-site researcher allocated treatments using minimisation.
METHODS: Four rehabilitation centres in the Netherlands.
METHODS: Forty-one patient-caregiver dyads within 3 months poststroke.
METHODS: 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.
METHODS: 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, p = 0.826). The secondary outcomes, namely, (a) caregivers\' quality of life postintervention (p = 0.013), (b) caregivers\' symptoms of depression postintervention (p = 0.025), and (c) independence in leisurely activities at 6 months (p = 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 (p = 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.
METHODS: Multicentre, observer-blinded, parallel randomised controlled trial. An off-site researcher allocated treatments using minimisation.
METHODS: Four rehabilitation centres in the Netherlands.
METHODS: Forty-one patient-caregiver dyads within 3 months poststroke.
METHODS: 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.
METHODS: 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, p = 0.826). The secondary outcomes, namely, (a) caregivers\' quality of life postintervention (p = 0.013), (b) caregivers\' symptoms of depression postintervention (p = 0.025), and (c) independence in leisurely activities at 6 months (p = 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 (p = 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：评估除常规护理外，护理人员介导的运动结合远程康复对亚急性卒中后自我报告的活动结局的附加价值。
方法：多中心，观察者失明,平行随机对照试验。场外研究人员使用最小化来分配治疗。
方法：荷兰有四个康复中心。
方法：中风后3个月内的41名患者-看护者。
方法：为期8周的混合护理计划，包括护理人员介导的每周2.5小时的活动能力锻炼，除了常规护理外，还包括远程康复和四次面对面治疗。
方法：干预后卒中影响量表的自我报告活动域。次要结果是功能结果，二元社会心理健康，护理过渡到社区干预后和6个月后。
结果：41个二元组(21个干预，20个对照)是随机的，37例(N=18；N=19)在意向治疗后进行了分析。干预后两组间卒中影响量表的移动度无显著差异(B0.8,95%CI-6.8-8.5,p=0.826)。次要结果，即,(A)护理人员干预后的生活质量(p=0.013)，(B)护理人员干预后的抑郁症状(p=0.025)，和(C)6个月时悠闲活动的独立性(p=0.024)，显示出明显的好处，有利于照顾者介导的远程康复锻炼。在6个月时的自我报告的肌肉力量中发现了有利于对照组的显着差异（p=0.002）。
结论：照顾者介导的运动结合远程康复对我们自我报告的主要结果没有不同的影响。虽然审判能力不足,目前的研究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社会心理健康的中风康复的有益效果。
方法：多中心，观察者失明,平行随机对照试验。场外研究人员使用最小化来分配治疗。
方法：荷兰有四个康复中心。
方法：中风后3个月内的41名患者-看护者。
方法：为期8周的混合护理计划，包括护理人员介导的每周2.5小时的活动能力锻炼，除了常规护理外，还包括远程康复和四次面对面治疗。
方法：干预后卒中影响量表的自我报告活动域。次要结果是功能结果，二元社会心理健康，护理过渡到社区干预后和6个月后。
结果：41个二元组(21个干预，20个对照)是随机的，37例(N=18；N=19)在意向治疗后进行了分析。干预后两组间卒中影响量表的移动度无显著差异(B0.8,95%CI-6.8-8.5,p=0.826)。次要结果，即,(A)护理人员干预后的生活质量(p=0.013)，(B)护理人员干预后的抑郁症状(p=0.025)，和(C)6个月时悠闲活动的独立性(p=0.024)，显示出明显的好处，有利于照顾者介导的远程康复锻炼。在6个月时的自我报告的肌肉力量中发现了有利于对照组的显着差异（p=0.002）。
结论：照顾者介导的运动结合远程康复对我们自我报告的主要结果没有不同的影响。虽然审判能力不足,目前的研究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社会心理健康的中风康复的有益效果。
