Department of Surgery, Amsterdam Movement Sciences, Amsterdam UMC Location AMC, Amsterdam, The Netherlands.
Department of Surgery, Amsterdam UMC Location AMC, Amsterdam, The Netherlands.
BMJ Open. 2021 Mar 30;11(3):e042629. doi: 10.1136/bmjopen-2020-042629.
Distal radius fractures are among the most prevalent traumatic injuries worldwide. These injuries are associated with high healthcare-related and socioeconomic costs, mainly resulting from loss of productivity. To optimise recovery and return to work, wrist exercises are recommended. However, adherence to standard exercise regimens is low. Serious games provide a treatment platform for standardised postoperative care, uniting meaningful recovery with entertainment. Also, mobile serious games, for example, smartphone or tablet applications, are able to send practice reminders believed to improve self-efficacy.
To test the effectiveness of a mobile serious game for distal radius fracture rehabilitation compared with standard care, a multicentre, randomised controlled clinical trial was designed. Primary outcome will be the Patient-Rated Wrist Evaluation (PRWE) score after 6 weeks of treatment. Secondary outcomes are range of motion, grip strength, pain scores, and self-reported treatment adherence after 2, 6 and 12 weeks of treatment.Adult patients with any type of closed distal radius fracture are included directly after non-operative or operative fracture treatment. Patients are recruited in the outpatient clinics of four teaching hospitals. The intended sample size is 92 patients, based on the minimal clinically important difference of the PRWE score at 6 weeks, using a superiority model.Patients are randomised between using the wearable-controlled mobile serious game (intervention group) and standard care consisting of unsupervised exercises and a referral for physiotherapy or exercise therapy upon request or recommendation by the treating clinician (control group).
The protocol has been approved by the Medical Ethical Review Board of the Amsterdam University Medical Centres, location Academic Medical Centre in Amsterdam, the Netherlands. Results will be made available to involved healthcare providers, funders, and to the general public including patients via peer-reviewed academic journals and international conferences.
Dutch Trial Registry (NTR), NL6140, protocol V.2.
桡骨远端骨折是全球最常见的外伤性损伤之一。这些损伤与高医疗保健相关和社会经济成本相关联，主要是由于生产力损失所致。为了优化康复和重返工作岗位，建议进行腕部运动。然而，标准运动方案的依从性较低。严肃游戏为标准化术后护理提供了一个治疗平台，将有意义的康复与娱乐结合在一起。此外，移动严肃游戏，例如智能手机或平板电脑应用程序，能够发送练习提醒，据信可以提高自我效能。
为了测试移动严肃游戏在桡骨远端骨折康复中的有效性与标准护理相比，设计了一项多中心、随机对照临床试验。主要结局将是治疗 6 周后患者自评腕关节评估（PRWE）评分。次要结局是治疗后 2、6 和 12 周的活动范围、握力、疼痛评分和自我报告的治疗依从性。任何类型的闭合性桡骨远端骨折的成年患者在非手术或手术治疗后直接纳入。患者在四家教学医院的门诊招募。根据 PRWE 评分的最小临床重要差异，预计样本量为 92 例，采用优效模型。患者随机分配至使用可穿戴控制的移动严肃游戏（干预组）或标准护理，标准护理包括非监督运动以及根据治疗医生的建议或推荐转介物理治疗或运动治疗（对照组）。
该方案已获得荷兰阿姆斯特丹大学医学中心阿姆斯特丹学术医学中心医学伦理审查委员会的批准。结果将提供给参与的医疗保健提供者、资助者以及通过同行评议的学术期刊和国际会议向公众，包括患者。
荷兰试验注册处（NTR），NL6140，方案 V.2。
