Eichler Sarah, Rabe Sophie, Salzwedel Annett, Müller Steffen, Stoll Josefine, Tilgner Nina, John Michael, Wegscheider Karl, Mayer Frank, Völler Heinz
Center of Rehabilitation Research, University of Potsdam, Am Neuen Palais 10, 14469, Potsdam, Germany.
University Outpatient Clinic, Center of Sports Medicine, University of Potsdam, Am Neuen Palais 10, 14469, Potsdam, Germany.
Trials. 2017 Sep 21;18(1):438. doi: 10.1186/s13063-017-2173-3.
Total hip or knee replacement is one of the most frequently performed surgical procedures. Physical rehabilitation following total hip or knee replacement is an essential part of the therapy to improve functional outcomes and quality of life. After discharge from inpatient rehabilitation, a subsequent postoperative exercise therapy is needed to maintain functional mobility. Telerehabilitation may be a potential innovative treatment approach. We aim to investigate the superiority of an interactive telerehabilitation intervention for patients after total hip or knee replacement, in comparison to usual care, regarding physical performance, functional mobility, quality of life and pain.
METHODS/DESIGN: This is an open, randomized controlled, multicenter superiority study with two prospective arms. One hundred and ten eligible and consenting participants with total knee or hip replacement will be recruited at admission to subsequent inpatient rehabilitation. After comprehensive, 3-week, inpatient rehabilitation, the intervention group performs a 3-month, interactive, home-based exercise training with a telerehabilitation system. For this purpose, the physiotherapist creates an individual training plan out of 38 different strength and balance exercises which were implemented in the system. Data about the quality and frequency of training are transmitted to the physiotherapist for further adjustment. Communication between patient and physiotherapist is possible with the system. The control group receives voluntary, usual aftercare programs. Baseline assessments are investigated after discharge from rehabilitation; final assessments 3 months later. The primary outcome is the difference in improvement between intervention and control group in 6-minute walk distance after 3 months. Secondary outcomes include differences in the Timed Up and Go Test, the Five-Times-Sit-to-Stand Test, the Stair Ascend Test, the Short-Form 36, the Western Ontario and McMaster Universities Osteoarthritis Index, the International Physical Activity Questionnaire, and postural control as well as gait and kinematic parameters of the lower limbs. Baseline-adjusted analysis of covariance models will be used to test for group differences in the primary and secondary endpoints.
We expect the intervention group to benefit from the interactive, home-based exercise training in many respects represented by the study endpoints. If successful, this approach could be used to enhance the access to aftercare programs, especially in structurally weak areas.
German Clinical Trials Register (DRKS), ID: DRKS00010009 . Registered on 11 May 2016.
全髋关节或膝关节置换术是最常开展的外科手术之一。全髋关节或膝关节置换术后的物理康复是改善功能结局和生活质量治疗的重要组成部分。住院康复出院后,需要进行后续的术后运动治疗以维持功能活动能力。远程康复可能是一种潜在的创新治疗方法。我们旨在研究与常规护理相比,交互式远程康复干预对全髋关节或膝关节置换术后患者在身体表现、功能活动能力、生活质量和疼痛方面的优越性。
方法/设计:这是一项开放、随机对照、多中心优越性研究,有两个前瞻性研究组。110名符合条件且同意参与的全膝关节或髋关节置换患者将在后续住院康复入院时招募。经过为期3周的全面住院康复后,干预组使用远程康复系统进行为期3个月的交互式家庭锻炼训练。为此,物理治疗师从系统中实施的38种不同的力量和平衡练习中制定个性化训练计划。有关训练质量和频率的数据传输给物理治疗师以进行进一步调整。患者和物理治疗师之间可通过该系统进行沟通。对照组接受自愿的常规后续护理计划。康复出院后进行基线评估;3个月后进行最终评估。主要结局是3个月后干预组和对照组在6分钟步行距离改善方面的差异。次要结局包括定时起立行走测试、五次坐立测试、上楼梯测试、简明健康调查问卷、西安大略和麦克马斯特大学骨关节炎指数、国际体力活动问卷、姿势控制以及下肢步态和运动学参数的差异。将使用基线调整的协方差分析模型来检验主要和次要终点的组间差异。
我们预计干预组将从以研究终点为代表的多方面交互式家庭锻炼训练中受益。如果成功,这种方法可用于增加获得后续护理计划的机会,尤其是在结构薄弱地区。
德国临床试验注册中心(DRKS),编号:DRKS00010009。于2016年5月11日注册。