Computer-Aided Physical Rehabilitation of Older People: A Pilot Non-Inferiority Randomized Clinical Trial

M. Randriambelonoro, C. Perrin, G. Carmona, E. Frangos, Herrmann Fr, A. Geissbühler, Graf Ce
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Abstract

Background: Developed countries are facing the challenge of aging societies, a high risk of dependence and high cost of care. Researchers attempted to address these issues by using cost-efficient, innovative technology to promote healthy aging and to regain functionality. After an injury, efficient rehabilitation is crucial to promote returning home and to prevent institutionalization. However, there is often a lack of motivation to carry out physical therapies. Consequently, there is a growing interest in testing new approaches like computer-aided rehabilitation to achieve functional targets and prevent re-hospitalization. Trial design: Pilot multicenter non-inferiority randomized clinical trial. Objectives: To assess the efficacy of a personal mobility device compared with standard of care in the rehabilitation treatment of patient with musculoskeletal issues. Methods: 57 patients aged 67-95 years were randomly assigned to the intervention group (n=35) using the gamified rehabilitation equipment 3 times a week or to a control group (n=22) receiving usual standard care. Outcome measures included SPPB (Short Physical Performance Battery), IHGS (Isometric Hand Grip Strength), FIM (Functional Independence Measure) and number of steps. Results: There were no significant differences between the control and the intervention groups for the primary outcome (SPPB) or any of the secondary outcomes (IHGS, FIM and steps), which demonstrates the non-inferiority effect of the serious game-based intervention. The analysis by mixed-effects regression on SPPB showed no indication of a group x time interaction (SPPB_I_t1=-0.76, p=0.26; SPPB_I_t2=0.21, p=0.74). Although not significant, a positive IHGS improvement of more than 2kg (Right: 2.52kg; Left: 2.43kg) for the patient from the intervention group was observed. In addition, patients who received the intervention exhibited stronger engagement in the rehabilitation process and a higher motivation to being more active. Conclusions: Serious game-based rehabilitation could be an effective alternative for older patients to regain their functional capacities.
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计算机辅助老年人身体康复:一项非劣效性随机临床试验
背景:发达国家正面临老龄化社会、高依赖风险和高护理成本的挑战。研究人员试图通过使用成本效益高的创新技术来解决这些问题,以促进健康衰老并恢复功能。受伤后,有效的康复对于促进回家和防止住院至关重要。然而,人们往往缺乏进行物理治疗的动力。因此,人们对测试计算机辅助康复等新方法越来越感兴趣,以实现功能目标并防止再次住院。试验设计:中试多中心非劣效性随机临床试验。目的:评估个人移动设备与标准护理在肌肉骨骼问题患者康复治疗中的疗效。方法:将57名年龄在67-95岁的患者随机分为干预组(n=35)和对照组(n=22),干预组每周使用游戏化康复设备3次,对照组接受常规标准护理。结果测量包括SPPB(短体力电池)、IHGS(等长握力)、FIM(功能独立性测量)和步骤数。结果:对照组和干预组在主要结果(SPPB)或任何次要结果(IHGS、FIM和步骤)方面没有显著差异,这表明基于严重游戏的干预具有非劣效性。SPPB的混合效应回归分析没有显示出组x时间相互作用的迹象(SPPBI_t1=0.76,p=0.26;SPPBI_t2=0.21,p=0.74)。尽管不显著,但观察到干预组患者的IHGS改善超过2kg(右:2.52kg;左:2.43kg)。此外,接受干预的患者在康复过程中表现出更强的参与度和更积极的动机。结论:认真的游戏康复可能是老年患者恢复功能的有效选择。
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