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 group  = 23; control group  = 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-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 ( > 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.

Conclusion: The additional robot-assisted therapy was safe, acceptable but showed no improvement in functional shoulder outcome compared to usual therapy only.