Robot-assisted training after proximal humeral fracture: A randomised controlled multicentre intervention trial

Objective: 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). Design: Multicentre, assessor-blinded, randomised controlled prospective trial. Setting: Three different rehabilitation hospitals in Germany. Subjects: In total 928 PHF patients between 35 and 70 years were screened. Forty-eight participants were included in the study (intervention groupn = 23; control groupn = 25). Intervention: 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(R)-Spring. Main measures: 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. Results: The mean age of participants was 55 +/- 10 years and was similar in both groups (p > 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 (p > 0.05). None of the follow-up time points demonstrated an additional benefit of the robotic therapy. Conclusion: The additional robot-assisted therapy was safe, acceptable but showed no improvement in functional shoulder outcome compared to usual therapy only.

Automated summary

The study found that robotic-assisted training as a supplement to usual therapy for proximal humeral fractures (PHF) is safe and acceptable, but did not show any improvement in functional shoulder outcome compared to usual therapy only. There were no significant differences in functional assessment outcomes between the intervention group and the control group.