Henkelmann Ralf, Schneider Sebastian, Müller Daniel, Gahr Ralf, Josten Christoph, Böhme Jörg
Clinic of Orthopaedics, Trauma and Plastic Surgery, University of Leipzig, Liebigstr. 20, Leipzig, 04103, Germany.
Hospital St. Georg gGmbH, Clinic of Trauma, Orthopedic and Septic Surgery, Delitzscher Str. 141, Leipzig, 04129, Germany.
BMC Musculoskelet Disord. 2017 Mar 14;18(1):104. doi: 10.1186/s12891-017-1461-0.
Partial or complete immobilization leads to different adjustment processes like higher risk of muscle atrophy or a decrease of general performance. The present study is designed to prove efficacy of the anti-gravity treadmill (alter G®) compared to a standard rehabilitation protocol in patients with tibial plateau (group 1)or ankle fractures (group 2) with six weeks of partial weight bearing of 20 kg.
This prospective randomized study will include a total of 60 patients for each group according to predefined inclusion and exclusion criteria. 1:1 randomization will be performed centrally via fax supported by the Clinical Trial Centre Leipzig (ZKS Leipzig). Patients in the treatment arm will be treated with an anti-gravity treadmill (alter G®) instead of physiotherapy. The protocol is designed parallel to standard physiotherapy with a frequency of two to three times of training with the treadmill per week with duration of 20 min for six weeks.
Up to date no published randomized controlled trial with an anti-gravity treadmill is available. The findings of this study can help to modify rehabilitation of patients with partial weight bearing due to their injury or postoperative protocol. It will deliver interesting results if an anti-gravity treadmill is useful in rehabilitation in those patients. Further ongoing studies will identify different indications for an anti-gravity treadmill. Thus, in connection with those studies, a more valid statement regarding safety and efficacy is possible.
NCT02790229 registered on May 29, 2016.
部分或完全固定会导致不同的适应过程，如肌肉萎缩风险增加或整体机能下降。本研究旨在证明，对于胫骨平台骨折患者（第1组）或踝关节骨折患者（第2组），在部分负重20千克六周的情况下，与标准康复方案相比，抗重力跑步机（alter G®）的疗效。
根据预先确定的纳入和排除标准，这项前瞻性随机研究每组将总共纳入60名患者。通过莱比锡临床试验中心（ZKS Leipzig）支持的传真进行集中1:1随机分组。治疗组的患者将使用抗重力跑步机（alter G®）进行治疗，而非物理治疗。该方案与标准物理治疗并行设计，每周使用跑步机进行两到三次训练，每次持续20分钟，共六周。
目前尚无已发表的关于抗重力跑步机的随机对照试验。本研究结果有助于因受伤或术后方案而部分负重的患者调整康复方案。如果抗重力跑步机对这些患者的康复有用，将得出有趣的结果。进一步正在进行的研究将确定抗重力跑步机的不同适应症。因此，结合这些研究，有可能就安全性和疗效作出更有效的陈述。
于2016年5月29日注册，注册号为NCT02790229。
