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

Abstract

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 n = 23; control group n = 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 (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.