Institute for Biomechanics, Berufsgenossenschaftliche Unfallklinik Murnau, Murnau, Germany.
Institute for Biomechanics, Paracelsus Medical University, Salzburg, Austria.
Clin Rehabil. 2021 Feb;35(2):242-252. doi: 10.1177/0269215520961654. Epub 2020 Oct 5.
To examine whether robotic-assisted training as a supplement to usual therapy is safe, acceptable and improves function and patient reported outcome after proximal humeral fractures (PHF).
Multicentre, assessor-blinded, randomised controlled prospective trial.
Three different rehabilitation hospitals in Germany.
In total 928 PHF patients between 35 and 70 years were screened. Forty-eight participants were included in the study (intervention group = 23; control group = 25).
The control group received usual occupational and physiotherapy over three weeks, and the intervention group received additional 12 robot-assisted training sessions at the ARMEO-Spring.
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), the Wolf Motor Function Test-Orthopaedic, active range of motion and grip strength were determined before and after intervention period. The DASH was additionally obtained postal 6 and 13 months following surgery.
The mean age of participants was 55 ± 10 years and was similar in both groups ( > 0.05). The change in DASH as the primary endpoint in the intervention group after intervention was -15 (CI = 8-22), at follow-up six month -7 (CI = -2 to 16) at follow up 13 month -9 (CI = 1-16); in control group -14 (CI = 11-18), at follow-up six month -13 (CI = 7-19) at follow up 13 month -6 (CI = -3 to 14). No difference in the change was found between groups ( > 0.05). None of the follow-up time points demonstrated an additional benefit of the robotic therapy.
The additional robot-assisted therapy was safe, acceptable but showed no improvement in functional shoulder outcome compared to usual therapy only.
研究在肱骨近端骨折（PHF）患者中，机器人辅助训练作为常规治疗的补充，是否安全、可接受，并能改善功能和患者报告的结果。
多中心、评估者盲法、随机对照前瞻性试验。
德国三家不同的康复医院。
共筛选了 35 至 70 岁的 928 名 PHF 患者。48 名参与者被纳入研究（干预组 23 名；对照组 25 名）。
对照组在 3 周内接受常规职业和物理治疗，干预组在 ARMEO-Spring 上额外接受 12 次机器人辅助训练。
手臂、肩部和手部残疾问卷（DASH）、Wolf 运动功能测试-矫形、主动活动范围和握力在干预前后进行测定。术后 6 个月和 13 个月时，DASH 也通过邮寄方式获得。
参与者的平均年龄为 55 ± 10 岁，两组间相似（>0.05）。干预组的主要终点 DASH 在干预后变化为-15（CI=8-22），在 6 个月随访时为-7（CI=-2 至 16），在 13 个月随访时为-9（CI=1-16）；对照组的变化为-14（CI=11-18），在 6 个月随访时为-13（CI=7-19），在 13 个月随访时为-6（CI=-3 至 14）。两组间的变化无差异（>0.05）。在任何随访时间点，机器人治疗均未显示出额外的功能益处。
与单纯常规治疗相比，附加的机器人辅助治疗是安全的、可接受的，但在改善肩部功能结果方面没有改善。
