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首页> 外文期刊>Orthopaedic Journal of Sports Medicine >A Randomised Controlled Study Protocol on the Maxm Skate; A Lower Limb Rehabilitation Device for use following Total Knee Arthroplasty
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A Randomised Controlled Study Protocol on the Maxm Skate; A Lower Limb Rehabilitation Device for use following Total Knee Arthroplasty

机译：Maxm溜冰鞋上的随机对照研究方案;全膝关节置换术后使用的下肢康复设备

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Background: Following Total Knee Arthroplasty (TKA) patients experience lower extremity muscle weakness and commonly require physical rehabilitation to enhance functional outcomes and overall recovery.~(1)In Australia, there are recognised variations in rehabilitative care following TKA, however rehabilitation most commonly provided is in an outpatient setting, on a one-to-one treatment basis.~(2)Outpatient physiotherapy is beneficial as the physiotherapist can monitor progress and modify therapy, however such methods are resource- intensive and impose a significant cost burden.~(1)The number of TKA procedures is rising, bringing concern of the sustainability and economic impact of one-to-one rehabilitation. Further research is needed to determine whether outpatient physiotherapy yields superior outcomes compared to less-costly alternatives such as group or home-based rehabilitation. The Maxm skate is a portable, lower limb post-operative and post-injury rehabilitation exercise device for individual use in a hospital or home-based setting. The Skate intends to facilitate rehabilitation and conditioning through graded therapeutic exercises and minimal joint loading. Study investigators aim to conduct a randomised controlled trial (RCT) to compare the safety, efficacy and cost-effectiveness of the Maxm Skate rehabilitation device to standard rehabilitative care. The primary outcome is to assess the range of motion (ROM) achieved by patients whom received the Maxm Skate device compared with standard care, 3 months postoperatively. Methods: This is a study protocol for an open-label RCT, in which 116 participants will be randomly allocated to an interventional or control group. A total of 58 participants per group will provide 90.0% power (α=0.05) to detect 10 degrees of difference (SD=16) in ROM, at 3 months post TKA. Participants assigned to the interventional group will receive the Maxm Skate in addition to standard care in the in-patient setting. Following discharge, participants will be asked to limit physiotherapy to Skate use only, and compliance will be documented. Outcomes will be compared to those receiving standard rehabilitative care. A blinded physiotherapist will evaluate functional outcomes preoperatively and at 2, 4, 6, 12, 26 and 52 weeks post TKA. The functional assessment will include measures of knee ROM, pain, isometric knee strength, balance, and knee/thigh circumference. Limited measures will also be assessed at Day 2 postoperatively by an alternate, un-blinded physiotherapist. Clinical and patient-reported outcome measures will be administered preoperatively, and at 6, 12 and 52 weeks postoperatively. An economic evaluation assessing the relative cost-effectiveness of the Maxm Skate rehabilitation device, compared to standard care, will be conducted. Patients will also be screened for adverse event occurrences and complications from the time of consent to 1 year postoperatively. Discussion: This clinical trial is the first developed to assess the efficacy of the Maxm Skate on patient’s rehabilitation following TKA. Trial Registration: ACTRN: ACTRN12616001081404p References: ~(1)Pozzi F, Snyder-Mackler L, Zeni J. Physical exercise after knee arthroplasty: a systematic review of controlled trials. Euro J Phys Rehabil Med. 2013;49(6):877-92.~(2)Naylor J, Harmer A, Fransen M, Crosbie J, Innes L. Status of physiotherapy rehabilitation after total knee replacement in Australia. Physiother Res Int. 2006;11(1):35-47.
机译：背景：全膝关节置换术（TKA）后患者出现下肢肌肉无力，通常需要进行物理康复以增强功能结局和总体康复。〜（1）在澳大利亚，公认的TKA术后康复护理存在差异，但是最常提供康复治疗〜（2）门诊理疗是有益的，因为理疗师可以监视进展情况并修改治疗方法，但是这种方法耗费资源，并带来巨大的成本负担。 1）TKA程序数量在增加，引起了对一对一康复的可持续性和经济影响的关注。与诸如团体或家庭康复等成本较低的替代方案相比，需要进一步的研究来确定门诊物理疗法是否能产生更好的效果。 Maxm溜冰鞋是一种便携式，下肢术后和损伤后康复锻炼设备，可在医院或家庭环境中单独使用。溜冰鞋打算通过分级治疗运动和最小的关节负荷来促进康复和适应。研究调查人员旨在进行一项随机对照试验（RCT），以比较Maxm Skate康复设备与标准康复治疗的安全性，有效性和成本效益。主要结果是评估术后3个月与标准护理相比接受Maxm Skate装置的患者的运动范围（ROM）。方法：这是一项开放标签RCT的研究方案，其中116名参与者将被随机分配至干预组或对照组。在TKA后3个月，每组总共58位参与者将提供90.0％的能量（α= 0.05），以检测ROM中的10度差异（SD = 16）。分配给干预组的参与者除了在住院环境中接受标准护理外，还将获得Maxm Skate。出院后，将要求参与者将物理治疗仅限于滑冰，并记录其依从性。结果将与接受标准康复治疗的患者进行比较。失明的理疗师将在TKA术后2、4、6、12、26和52周评估术前的功能结局。功能评估将包括膝盖ROM，疼痛，等距膝盖力量，平衡和膝盖/大腿围的测量。术后第二天还将由另一位无盲理疗师评估有限的措施。临床和患者报告的结局指标将在术前，术后第6、12和52周进行。将进行经济评估，评估与标准护理相比，Maxm Skate康复器械的相对成本效益。从同意时间到术后1年，还将对患者进行不良事件发生和并发症的筛查。讨论：该临床试验是第一个评估Maxm Skate在TKA后对患者康复的疗效的试验。试验注册：ACTRN：ACTRN12616001081404p参考文献：〜（1）Pozzi F，Snyder-Mackler L，ZeniJ。膝关节置换术后的体育锻炼：对对照试验的系统评价。欧洲J物理康复医学。 2013; 49（6）：877-92。〜（2）Naylor J，Harmer A，Fransen M，Crosbie J，Innes L.澳大利亚全膝关节置换术后理疗康复的状况。 Physiother Res Int。 2006; 11（1）：35-47。

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