S. Furtado, North of England Bone and Soft Tissue Tumor Service, Department of Orthopaedics, Freeman Hospital, Newcastle Upon Tyne, United Kingdom.
A. Godfrey, Computer and Information Sciences Department, Northumbria University, Newcastle upon Tyne, UK.
Clin Orthop Relat Res. 2020 Mar;478(3):482-503. doi: 10.1097/CORR.0000000000000883.
Aspects of physical functioning, including balance and gait, are affected after surgery for lower limb musculoskeletal tumors. These are not routinely measured but likely are related to how well patients function after resection or amputation for a bone or soft tissue sarcoma. Small, inexpensive portable accelerometers are available that might be clinically useful to assess balance and gait in these patients, but they have not been well studied.
QUESTIONS/PURPOSES: In patients treated for lower extremity musculoskeletal tumors, we asked: (1) Are accelerometer-based body-worn monitor assessments of balance, gait, and timed up-and-go tests (TUG) feasible and acceptable? (2) Do these accelerometer-based body-worn monitor assessments produce clinically useful data (face validity), distinguish between patients and controls (discriminant validity), reflect findings obtained using existing clinical measures (convergent validity) and standard manual techniques in clinic (concurrent validity)?
This was a prospective cross-sectional study. Out of 97 patients approached, 34 adult patients treated for tumors in the femur/thigh (19), pelvis/hip (3), tibia/leg (9), or ankle/foot (3) were included in this study. Twenty-seven had limb-sparing surgery and seven underwent amputation. Patients performed standard activities while wearing a body-worn monitor on the lower back, including standing, walking, and TUG tests. Summary measures of balance (area [ellipsis], magnitude [root mean square {RMS}], jerkiness [jerk], frequency of postural sway below which 95% of power of acceleration power spectrum is observed [f95 of postural sway]), gait [temporal outcomes, step length and velocity], and TUG time were derived. Body-worn monitor assessments were evaluated for feasibility by investigating data loss and patient-reported acceptability and comfort. In addition, outcomes in patients were compared with datasets of healthy participants collected in parallel studies using identical methods as in this study to assess discriminant validity. Body-worn monitor assessments were also investigated for their relationships with routine clinical scales (the Musculoskeletal Tumour Society Scoring system [MSTS], the Toronto Extremity Salvage Score [TESS], and the Quality of life-Cancer survivors [QoL-CS)] to assess convergent validity and their agreement with standard manual techniques (video and stopwatch) to assess concurrent validity.
Although this was a small patient group, there were initial indications that body-worn monitor assessments were well-tolerated, feasible to perform, acceptable to patients who responded (95% [19 of 20] of patients found the body-worn monitor acceptable and comfortable and 85% [17 of 20] found it user-friendly), and produced clinically useful data comparable with the evidence. Balance and gait measures distinguished patients and controls (discriminant validity), for instance balance outcome (ellipsis) in patients (0.0475 m/s [95% confidence interval 0.0251 to 0.0810]) was affected compared with controls (0.0007 m/s [95% CI 0.0003 to 0.0502]; p = 0.001). Similarly gait outcome (step time) was affected in patients (0.483 seconds [95% CI 0.451 to 0.512]) compared with controls (0.541 seconds [95% CI 0.496 to 0.573]; p < 0.001). Moreover, body-worn monitor assessments showed relationships with existing clinical scales (convergent validity), for instance ellipsis with MSTS (r = -0.393; p = 0.024). Similarly, manual techniques showed excellent agreement with body-worn monitor assessments (concurrent validity), for instance stopwatch time 22.28 +/- 6.93 seconds with iTUG time 21.18 +/- 6.23 seconds (intraclass correlation coefficient agreement = 0.933; p < 0.001). P < 0.05 was considered statistically significant.
Although we had a small, heterogeneous patient population, this pilot study suggests that body-worn monitors might be useful clinically to quantify physical functioning in patients treated for lower extremity tumors. Balance and gait relate to disability and quality of life. These measurements could provide clinicians with useful novel information on balance and gait, which in turn could guide rehabilitation strategies.
Level III, diagnostic study.
下肢肌肉骨骼肿瘤手术后，身体机能的各个方面都会受到影响，包括平衡和步态。这些方面并未常规测量，但可能与患者切除或截肢骨或软组织肉瘤后的功能恢复情况有关。目前有一些小型、价格低廉的便携式加速度计，可用于评估这些患者的平衡和步态，但这些仪器尚未得到充分研究。
问题/目的：在接受下肢肌肉骨骼肿瘤治疗的患者中，我们提出以下问题：（1）基于穿戴式身体传感器的平衡、步态和计时起立行走测试（TUG）评估方法是否可行且可接受？（2）这些基于穿戴式身体传感器的评估方法能否提供具有临床意义的数据（表面有效性），能否区分患者和对照组（判别有效性），能否反映现有临床测量方法（收敛有效性）和诊所标准手动技术（同时有效性）的结果？
这是一项前瞻性的横断面研究。在 97 名被调查患者中，34 名接受股骨/大腿（19 例）、骨盆/髋部（3 例）、胫骨/小腿（9 例）或踝/脚（3 例）肿瘤治疗的成年患者纳入本研究。其中 27 例患者行保肢手术，7 例行截肢手术。患者在背部佩戴身体传感器进行标准活动，包括站立、行走和 TUG 测试。从平衡（面积[省略号]、幅度[均方根{ RMS }]、急动度[急动]、观察到加速度功率谱的 95%功率下的姿势摆动频率[f95 of postural sway]）、步态[时间结局、步长和速度]和 TUG 时间中得出总结性测量结果。通过研究数据丢失和患者报告的可接受性和舒适度来评估身体传感器评估的可行性。此外，通过将患者的结果与使用相同方法平行研究中收集的健康参与者数据集进行比较，评估判别有效性。还研究了身体传感器评估与常规临床量表（肌肉骨骼肿瘤学会评分系统[MSTS]、多伦多肢体挽救评分[TESS]和癌症幸存者生活质量[QoL-CS]）的关系，以评估收敛有效性，并与标准手动技术（视频和秒表）的一致性，以评估同时有效性。
尽管这是一个小患者群体，但初步结果表明，身体传感器评估是可以耐受的，可行的，且患者的接受度较高（95%[20 名患者中的 19 名]的患者认为身体传感器可接受和舒适，85%[20 名患者中的 17 名]的患者认为使用方便），并产生具有临床意义的、可与证据相媲美的数据。平衡和步态测量结果可区分患者和对照组（判别有效性），例如患者的平衡结果（省略号）为 0.0475 m/s（95%置信区间为 0.0251 至 0.0810），而对照组为 0.0007 m/s（95%置信区间为 0.0003 至 0.0502）；p = 0.001）。同样，患者的步态结果（步时）为 0.483 秒（95%置信区间为 0.451 至 0.512），而对照组为 0.541 秒（95%置信区间为 0.496 至 0.573）；p < 0.001）。此外，身体传感器评估与现有临床量表（收敛有效性）相关，例如省略号与 MSTS（r = -0.393；p = 0.024）。同样，手动技术与身体传感器评估具有极好的一致性（同时有效性），例如秒表时间 22.28 +/- 6.93 秒与 iTUG 时间 21.18 +/- 6.23 秒（组内相关系数一致性 = 0.933；p < 0.001）。p < 0.05 被认为具有统计学意义。
尽管我们的患者人群较小且存在异质性，但这项初步研究表明，身体传感器在临床上可能有助于量化下肢肿瘤患者的身体机能。平衡和步态与残疾和生活质量有关。这些测量结果可为临床医生提供有关平衡和步态的有用的新信息，进而可以指导康复策略。
三级，诊断研究。
