Aim of this prospective randomised open-label multicenter study was to prove the effect of an antigravity treadmill (AGT) with patients with postoperative partial-weight bearing compared with patients with a standard rehabilitation protocol.
This multicenter prospective 1:1 randomized controlled open-label study was done at three Level-1 trauma centers. Patients in the control group (CG) received standard physiotherapy including manual lymphatic drainage, cryotherapy and 20-minute physiotherapy for six weeks, two to three times per week. Patients in the intervention group (IG) received manual lymphatic drainage, cryotherapy and 20-minute exercise on the AGT two to three times per week according to a predefined schedule. The primary endpoint of the short term follow-up is the change in FAOS5 (Foot and Ankle Outcome Score) in ankle fractures (AF) and KOOS5 (Knee injury and Osteoarthritis Outcome Score) in tibial plateau fractures (TPF), respectively from baseline (V1) to day of discharge (V2), after six weeks of intervention (V4) and after 12 months (V6) in each group and in comparison of both groups. Baseline is defined as the day on which the patient is enrolled in the study. Due to the design of the patient reported outcome (PRO), the baseline reflects the patient's healthy uninjured condition. Secondary endpoints are changes in FAOS5 subscores (Symptoms, Pain, Function in daily living (ADL), Function/sports and recreational activities (Sport/Rec), Quality of Life (QoL) for ankle fractures and the KOOS5 subscores (same subscores as for FAOS5) for tibial plateau fractures from V1 to V2, V4 and V6 for each group and in comparison of both groups. Circumference measurement for quantitative assessment of muscular atrophy of thighs and lower leg was performed at 10 cm and 20 cm above the knee joint line and 10 cm below (knee in neutral position) from V1 to V2, V4 and V6 for each group and between groups. Changes of the gait pattern were determined by comparison of V2 to V4 and V6 using the Dynamic Gait Index (DGI). Finally, 55 patients with a mean age of 42 years (range from 19 to 65) were included in the analyses. The groups were balanced in sex, age, body mass index (BMI), type of fracture and cause of accident. The patients of both groups with AF or TPF were balanced in the V1 of the total FAOS or total KOOS, respectively.
Already after 6 weeks of intervention, a significantly higher muscle atrophy was observed in the control group in patients with a tibial plateau fracture. A significant influence of the AGT on the PROs was not observed. However, it is interesting to note that treatment with the AGT was comparable to a specific treatment of a physiotherapist with patient guidance. There was no significant advantage of the AGT in AF and TPF in the individual subscores of the PROs after 52 weeks. At the end of the study, in addition to the continuing difference in muscle atrophy, which continued to differ significantly between the groups, an effect of the AGT on the gait pattern of patients with TPF, measured with the DGI, could be shown. This is interesting, because the DGI, in addition to "normal" walking on level ground, also takes into account changes in direction and climbing stairs and can better reflect the patient's everyday mobility.
-cross sectoral-Type of hazard:
rehabilitationDescription, key words:
Anti-gravity Treadmill, AlterG