Impact of anti-gravity treadmill rehabilitation therapy on the clinical outcomes after fixation of lower limb fractures: A randomized clinical trial

Abstract

Objective: To compare the effects of anti-gravity treadmill rehabilitation with those of standard rehabilitation on surgically treated ankle and tibial plateau fractures. Design: Open-label prospective randomized multicenter study. Setting: Three level 1 trauma centers. Subjects: Patients with tibial plateau or ankle fractures who underwent postoperative partial weight-bearing were randomized into the intervention (anti-gravity treadmill use) or control (standard rehabilitation protocol) groups. Main measures: The primary endpoint was the change in the Foot and Ankle Outcome Score for ankle fractures and total Knee injury and Osteoarthritis Outcome Score for tibial plateau fractures (0–100 points) from baseline (T1) to six weeks after operation (T4) in both groups. Leg circumference of both legs was measured to assess thigh muscle atrophy in the operated leg. Results: Thirty-seven patients constituted the intervention and 36 the control group, respectively; 14 patients dropped out during the follow-up period. Among the 59 remaining patients (mean age 42 [range, 19–65] years), no difference was noted in the Foot and Ankle Outcome Score (54.2 ± 16.1 vs. 56.0 ± 16.6) or Knee injury and Osteoarthritis Outcome Score (52.8 ± 18.3 vs 47.6 ± 17.7) between the intervention and control groups 6 weeks after operation. The change in the leg circumference from T1 to T4 was greater by 4.6 cm in the intervention group (95% confidence interval: 1.2–8.0, P = 0.005). No adverse event associated with anti-gravity treadmill rehabilitation was observed. Conclusion: No significant difference was noted in patient-reported outcomes between the two groups. Significant differences in muscular atrophy of the thigh were observed six weeks after operation.

Anti-gravity treadmill rehabilitation improves gait and muscle atrophy in patients with surgically treated ankle and tibial plateau fractures after one year: A randomised clinical trial

“…As already reported, in patients with tibial plateau fractures, the change in the leg circumference 20 cm above the knee joint from baseline to the end of the intervention after six weeks differed significantly by 4.6 cm ( P = 0.029). 10 This difference was still present after 12 months but to a lesser degree (3.1 cm; 95% CI 1.3–7.6 cm; P = 0.081). Furthermore, a difference in the change between baseline and the final follow-up was found for the leg circumference 10 cm below the knee joint (3.0 cm; 95% CI 0.2–6.3 cm; P = 0.28).…”

“…A detailed description of the statistical analyses can be found in our report of the initial study results. 10 Patient measurements were described as the mean ± standard deviation, the minimum and maximum values for continuous data and scores data and absolute and relative frequencies for count data. The primary and main secondary endpoints were analysed using linear mixed models with random intercepts.…”

“…A detailed description of the statistical analyses can be found in our report of the initial study results. 10…”

“…The methodology of the trial is described in detail in our previous reports. 10,14 We report the final results of the study after one year.…”

“…We recently compared a structured gait programme on an anti-gravity treadmill with a standardised rehabilitation programme in patients with postoperative partial weight-bearing, and to our knowledge, we are the first to show significant less muscle atrophy in treadmill training after six weeks. 10 However, the effect of an anti-gravity treadmill programme after the immediate postoperative mobilisation phase has not yet been reported. Therefore, we assessed the outcomes in the patients of our previous study after one year to understand the mid-term effect of anti-gravity treadmill rehabilitation.…”