Assistive robotic training after upper arm fractures - randomized intervention study

Status:

completed 03/2019

Aims:

This randomized, controlled, and partially blinded intervention study is designed to evaluate the efficacy of additional assistive robotic training (ArmeoSpring®) in the rehabilitative treatment of proximal humeral fractures (AO11). The aim was to evaluate a new therapy for patients after shoulder joint fractures. Therefore, the hypothesis was that an additive assistive robotic training over a period of 3 weeks would improve functional outcome in patients with upper arm fractures in the intervention group compared to the control group.

Activities/Methods:

From January 2016 to October 2018, a total of N=48 patients after proximal humeral fracture (AO11) were included in one of two groups in three centres (BG Unfallklinik Murnau, Robert-Bosch-Krankenhaus Stuttgart, BG-Unfallklinik Ludwigshafen): the control group received the physiotherapy individually prescribed by the treating physician over a period of 3 weeks while the intervention group additionally received 12 additive training sessions on the ArmeoSpring® robotic system. Before and after the intervention period, functionality was determined using the Wolf Motor Function Test Orthopeadic (WMFT-O), Range of Motion (RoM), grip strength, and the DASH score. The DASH score was additionally determined 3, 6 and 12 months after surgery.

Results:

Despite the consideration of covariates (e.g. severity of injury, extent of individual physiotherapy), none of the measuring instruments was able to identify a functional gain through additive robotic therapy at any of the follow-up appointments (DASH: p≥0.173; WMFT-O(Diff): p≥0.101; hand force (Diff): p=0.384; RoM(Diff): p≥0.092). Discussion: At no time of follow-up any gain from robotic therapy could be measured in patients with proximal humerus fractures aged 35-70 years. Factors that could influence the results (e.g. injury severity, extent of additional physiotherapy) were similarly distributed in both groups. It can therefore be assumed that in the selected collective and in the selected treatment period (at least 4 weeks after surgical treatment) no generalised benefit can be obtained from training with ArmeoSpring® if supplied as additive therapy.

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