Department for Arthroscopic Surgery, Sports Traumatology & Sports Medicine, BG Klinikum Duisburg, Duisburg, Germany.
Research Department, BG Klinikum Duisburg, Duisburg, Germany.
Trials. 2023 Mar 3;24(1):162. doi: 10.1186/s13063-023-07195-2.
The lateral ankle sprain (LAS) is the most common injury in the field of everyday and sports-related activities. There is a high rate of patients with LAS who will develop chronic ankle instability (CAI). A possible explanation for this high rate is an insufficient rehabilitation and/or a premature return to intense exercise and workloads. Currently, there are general rehabilitation guidelines for LAS but there is a lack of standardized evidenced-based rehabilitation concepts for LAS, which effectively reduce the high CAI rate. The primary aim of the study is to investigate the effectiveness of a 6-week sensorimotor training intervention (SMART-Treatment, SMART) in contrast to standard therapy (Normal Treatment, NORMT) after an acute LAS on perceived ankle joint function.
This study will be a prospective, single-center, interventional randomized controlled trial with an active control group. Patients (14-41 years) with an acute LAS and a MRI confirmed lesion or rupture of at least one ankle ligament will be included. Exclusion criteria are acute concomitant injuries of the ankle, pre-injuries of the ankle, serious lower-extremity injuries of the last 6 months, lower-extremity surgery, and neurological diseases. The primary outcome measure will be the Cumberland Ankle Instability Tool (CAIT). Secondary outcomes include the Foot and Ankle Ability Measurement (FAAM), isokinetic and isometric strength diagnostics, joint repositioning sense, range of motion, measurements of postural control, gait and run analysis, and jump analysis. This protocol will follow the SPIRIT guidance.
Current management of LAS rehabilitation lacks since there is a high rate of patients developing a CAI. It has been shown that exercise therapy improves ankle function in acute LAS as well as in patients with CAI. It is further recommended to address specific impairment domains in ankle rehabilitation. However, empirical data for such a holistic treatment algorithm is missing. Therefore, this study has the potential to improve the healthcare for LAS patients and might be used for a future standardized evidence-based rehabilitation concept.
"Prospectively registered" ISRCTN - ISRCTN13640422 17/11/2021; DRKS (German Clinical Trials Register) - DRKS00026049.
外侧踝关节扭伤（LAS）是日常和运动相关活动中最常见的损伤。有很高比例的 LAS 患者会发展为慢性踝关节不稳定（CAI）。造成这种高比例的一个可能原因是康复不充分和/或过早返回剧烈运动和工作量。目前，LAS 有一般的康复指南，但缺乏针对 LAS 的标准化循证康复概念，这些概念可以有效地降低 CAI 发生率。该研究的主要目的是调查 6 周感觉运动训练干预（SMART-Treatment，SMART）与急性 LAS 后标准治疗（Normal Treatment，NORMT）相比，对感知踝关节功能的有效性。
这是一项前瞻性、单中心、干预性随机对照试验，采用主动对照组。纳入有急性 LAS 和 MRI 证实的至少一条踝关节韧带损伤或断裂的患者（14-41 岁）。排除标准为急性踝关节伴发损伤、既往踝关节损伤、过去 6 个月严重下肢损伤、下肢手术和神经疾病。主要结局测量指标为坎伯兰踝关节不稳定性工具（CAIT）。次要结局包括足踝能力测量（FAAM）、等速和等长力量诊断、关节重定位感、运动范围、姿势控制测量、步态和跑步分析以及跳跃分析。本方案将遵循 SPIRIT 指南。
目前 LAS 康复管理缺乏，因为有很高比例的患者会发展为 CAI。运动疗法已被证明可改善急性 LAS 以及 CAI 患者的踝关节功能。进一步建议在踝关节康复中解决特定的功能障碍领域。然而，这种整体治疗算法的实证数据仍然缺乏。因此，本研究有可能改善 LAS 患者的医疗保健，并可能用于未来的标准化循证康复概念。
“前瞻性注册”ISRCTN - ISRCTN13640422 2021 年 11 月 17 日；DRKS（德国临床试验注册）- DRKS00026049。
