Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
PLoS Med. 2020 Feb 18;17(2):e1003029. doi: 10.1371/journal.pmed.1003029. eCollection 2020 Feb.
Digitally enabled rehabilitation may lead to better outcomes but has not been tested in large pragmatic trials. We aimed to evaluate a tailored prescription of affordable digital devices in addition to usual care for people with mobility limitations admitted to aged care and neurological rehabilitation.
We conducted a pragmatic, outcome-assessor-blinded, parallel-group randomised trial in 3 Australian hospitals in Sydney and Adelaide recruiting adults 18 to 101 years old with mobility limitations undertaking aged care and neurological inpatient rehabilitation. Both the intervention and control groups received usual multidisciplinary inpatient and post-hospital rehabilitation care as determined by the treating rehabilitation clinicians. In addition to usual care, the intervention group used devices to target mobility and physical activity problems, individually prescribed by a physiotherapist according to an intervention protocol, including virtual reality video games, activity monitors, and handheld computer devices for 6 months in hospital and at home. Co-primary outcomes were mobility (performance-based Short Physical Performance Battery [SPPB]; continuous version; range 0 to 3; higher score indicates better mobility) and upright time as a proxy measure of physical activity (proportion of the day upright measured with activPAL) at 6 months. The dataset was analysed using intention-to-treat principles. The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000936628). Between 22 September 2014 and 10 November 2016, 300 patients (mean age 74 years, SD 14; 50% female; 54% neurological condition causing activity limitation) were randomly assigned to intervention (n = 149) or control (n = 151) using a secure online database (REDCap) to achieve allocation concealment. Six-month assessments were completed by 258 participants (129 intervention, 129 control). Intervention participants received on average 12 (SD 11) supervised inpatient sessions using 4 (SD 1) different devices and 15 (SD 5) physiotherapy contacts supporting device use after hospital discharge. Changes in mobility scores were higher in the intervention group compared to the control group from baseline (SPPB [continuous, 0-3] mean [SD]: intervention group, 1.5 [0.7]; control group, 1.5 [0.8]) to 6 months (SPPB [continuous, 0-3] mean [SD]: intervention group, 2.3 [0.6]; control group, 2.1 [0.8]; mean between-group difference 0.2 points, 95% CI 0.1 to 0.3; p = 0.006). However, there was no evidence of a difference between groups for upright time at 6 months (mean [SD] proportion of the day spent upright at 6 months: intervention group, 18.2 [9.8]; control group, 18.4 [10.2]; mean between-group difference -0.2, 95% CI -2.7 to 2.3; p = 0.87). Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life. No adverse events were reported in the intervention group. Thirteen participants died while in the trial (intervention group: 9; control group: 4) due to unrelated causes, and there was no evidence of a difference between groups in fall rates (unadjusted incidence rate ratio 1.19, 95% CI 0.78 to 1.83; p = 0.43). Study limitations include 15%-19% loss to follow-up at 6 months on the co-primary outcomes, as anticipated; the number of secondary outcome measures in our trial, which may increase the risk of a type I error; and potential low statistical power to demonstrate significant between-group differences on important secondary patient-reported outcomes.
In this study, we observed improved mobility in people with a wide range of health conditions making use of digitally enabled rehabilitation, whereas time spent upright was not impacted.
The trial was prospectively registered with the Australian New Zealand Clinical Trials Register; ACTRN12614000936628.
数字化康复可能会带来更好的结果，但尚未在大型实用试验中进行测试。我们旨在评估在为接受老年护理和神经康复的患者提供常规护理的基础上，额外提供负担得起的数字设备的个性化处方。
我们在澳大利亚悉尼和阿德莱德的 3 家医院进行了一项实用、结局评估者设盲、平行组随机试验，招募年龄在 18 至 101 岁之间、有移动障碍、正在接受老年护理和神经科住院康复的成年人。干预组和对照组均接受了常规的多学科住院和出院后康复治疗，由治疗康复临床医生决定。除常规护理外，干预组还使用设备针对移动和身体活动问题进行治疗，这些设备是由物理治疗师根据干预方案单独开出的，包括虚拟现实视频游戏、活动监测器和手持式电脑设备，患者在住院期间和出院后 6 个月内使用这些设备。主要结局是 6 个月时的移动能力（表现性短体功测试[SPPB]；连续版本；范围为 0 至 3；得分越高表示移动能力越好）和直立时间（用 activPAL 测量的一天中直立的比例）。数据集使用意向治疗原则进行分析。该试验已在澳大利亚和新西兰临床试验注册中心（ACTRN12614000936628）进行了前瞻性注册。2014 年 9 月 22 日至 2016 年 11 月 10 日，共有 300 名患者（平均年龄 74 岁，标准差 14；50%为女性；54%为神经疾病导致活动受限）使用安全的在线数据库（REDCap）随机分配至干预组（n=149）或对照组（n=151），以实现分组隐匿。共有 258 名参与者（干预组 129 名，对照组 129 名）完成了 6 个月的评估。干预组参与者平均接受了 12 次（标准差 11 次）监督性住院治疗，使用了 4 种（标准差 1 种）不同的设备，出院后接受了 15 次（标准差 5 次）物理治疗，以支持设备使用。与对照组相比，干预组在基线（SPPB[连续，0-3]均值[标准差]：干预组，1.5[0.7]；对照组，1.5[0.8]）到 6 个月（SPPB[连续，0-3]均值[标准差]：干预组，2.3[0.6]；对照组，2.1[0.8]；组间平均差异 0.2 分，95%置信区间 0.1 至 0.3；p=0.006）时的移动能力评分更高。然而，在 6 个月时，两组之间直立时间没有差异（6 个月时每天直立的比例的均值[标准差]：干预组，18.2[9.8]；对照组，18.4[10.2]；组间平均差异-0.2，95%置信区间-2.7 至 2.3；p=0.87）。与对照组相比，干预组在大多数次要移动能力结局方面的评分更高，但在大多数其他次要结局方面，如自我报告的平衡信心和生活质量，两组之间没有差异。干预组没有报告不良事件。13 名参与者在试验期间死亡（干预组：9 名；对照组：4 名），死亡原因与试验无关，两组的跌倒率没有差异（未调整的发病率比 1.19，95%置信区间 0.78 至 1.83；p=0.43）。研究的局限性包括 6 个月时主要结局的随访率为 15%-19%，这是预期的；我们试验中的次要结局测量数量较多，这可能会增加 I 类错误的风险；以及在重要的患者报告结局方面，两组之间可能存在统计学意义的差异，但潜在的统计效能较低。
在这项研究中，我们观察到使用数字化康复的患者移动能力得到了改善，而直立时间没有受到影响。
该试验在澳大利亚和新西兰临床试验注册中心进行了前瞻性注册；ACTRN12614000936628。
