Agency for Healthcare Research and Quality, Department of Health and Human Services, Rockville, Maryland.
MedStar National Rehabilitation Hospital, Washington, District of Columbia.
JAMA Netw Open. 2020 Sep 1;3(9):e2016571. doi: 10.1001/jamanetworkopen.2020.16571.
Even without evidence, rehabilitation practitioners continue to introduce new interventions to enhance the mobility outcomes for the increasing population with a recent total knee arthroplasty (TKA).
To compare post-TKA functional mobility outcomes among 3 newly developed physical therapy protocols with a standard-of-care post-TKA rehabilitation protocol.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial included 4 study arms implemented in 15 outpatient clinics within a single health system in the Baltimore, Maryland, and Washington, District of Columbia, region from October 2013 to April 2017. Participants included patients who underwent elective unilateral TKA, were aged 40 years and older, and began outpatient physical therapy within 24 days after TKA. A total of 505 patients were screened and 386 participants were enrolled. Patients provided informed consent and were randomly assigned to 1 of 4 groups. Blinding patients and treating therapists was not feasible owing to the nature of the intervention. Analysis was conducted under the modified intent-to-treat principle from October 2017 to May 2019.
The control group used a standard recumbent bike for 15 to 20 minutes each session. Interventions used 1 of 3 modalities for 15 to 20 minutes each session: (1) a body weight-adjustable treadmill, (2) a patterned electrical neuromuscular stimulation device, or (3) a combination of the treadmill and electrical neuromuscular stimulation.
Outcomes included the Activity Measure for Post-acute Care basic mobility score, a patient-reported outcome measure, and the 6-minute walk test. Outcomes were measured at baseline, monthly, and on discharge from outpatient therapy.
Data from 363 patients (mean [SD] age, 63.4 [7.9] years; 222 [61.2%] women) were included in the final analysis, including 92 participants randomized to the control group, 91 participants randomized to the treadmill group, 90 participants randomized to the neuromuscular stimulation device group, and 90 participants randomized to the combination intervention group. Activity Measure for Post-acute Care scores at discharge were similar across groups, ranging from 61.1 to 61.3 (P = .99) with at least 9.0 points improvement (P = .80) since baseline. The distances as measured by the 6-minute walking test were not statistically different across groups (range, 382.9-404.5 m; P = .60).
This randomized clinical trial found no statistically or clinically significant differences in outcomes across the 4 arms. Because outcomes were similar among arms, clinicians should instead consider relative cost in tailoring TKA rehabilitation.
ClinicalTrials.gov Identifier: NCT02426190.
即使没有证据，康复从业者仍在继续引入新的干预措施，以提高最近接受全膝关节置换术（TKA）的患者群体的移动能力。
比较 3 种新开发的物理治疗方案与标准 TKA 康复方案在 TKA 后功能移动能力方面的结果。
设计、设置和参与者：这项随机临床试验包括在马里兰州巴尔的摩和华盛顿特区的单个医疗系统内的 15 个门诊诊所实施的 4 个研究臂，从 2013 年 10 月至 2017 年 4 月实施。参与者包括接受择期单侧 TKA 的患者，年龄 40 岁及以上，并且在 TKA 后 24 天内开始接受门诊物理治疗。共筛选了 505 名患者，有 386 名患者入组。患者提供了知情同意，并随机分配到 4 个组中的 1 个。由于干预的性质，无法对患者和治疗师进行盲法。从 2017 年 10 月到 2019 年 5 月，根据修改后的意向治疗原则进行了分析。
对照组在每次治疗中使用标准的卧式自行车 15 至 20 分钟。干预措施每次治疗使用 1 种模式 15 至 20 分钟：（1）可调节体重的跑步机，（2）模式化的电神经肌肉刺激设备，或（3）跑步机和电神经肌肉刺激的组合。
结果包括康复后活动测量基本移动评分、患者报告的结果测量和 6 分钟步行测试。在基线、每月和门诊治疗出院时进行测量。
共有 363 名患者（平均[标准差]年龄，63.4[7.9]岁；222[61.2%]名女性）纳入最终分析，包括 92 名随机分配至对照组的患者、91 名随机分配至跑步机组的患者、90 名随机分配至神经肌肉刺激装置组的患者和 90 名随机分配至联合干预组的患者。出院时的康复后活动测量评分在各组之间相似，范围为 61.1 至 61.3（P = .99），与基线相比至少提高了 9.0 分（P = .80）。6 分钟步行测试的距离在各组之间没有统计学差异（范围，382.9-404.5 m；P = .60）。
这项随机临床试验发现，4 个组之间的结果没有统计学或临床意义上的差异。由于各组之间的结果相似，临床医生应在定制 TKA 康复时考虑相对成本。
ClinicalTrials.gov 标识符：NCT02426190。
