Russell Esposito Elizabeth, Farrokhi Shawn, Shuman Benjamin R, Sessoms Pinata H, Szymanek Eliza, Hoppes Carrie W, Bechard Laura, King David, Fraser John J
Department of Defense -Veterans Affairs Extremity Trauma and Amputation Center of Excellence, Joint Base San Antonio-Fort Sam Houston, San Antonio, TX, United States.
Center for Limb Loss and Mobility, Veterans Affairs Puget Sound Health Care System, Seattle, WA, United States.
JMIR Res Protoc. 2022 Jun 22;11(6):e38442. doi: 10.2196/38442.
Lateral ankle sprains (LASs) are common injuries among military service members. Approximately 40% of individuals with an LAS progress to develop chronic ankle instability (CAI), a condition that results in substantial mechanical and neurophysiological impairment and activity limitation. Since proprioceptive and balance training improve functional outcomes and prevent secondary injury following LAS, they are recommended in clinical practice. Uneven treadmills are an innovative modality that challenge the sensorimotor system while performing an ecologically valid task simulating environments frequently encountered by service members with LAS and CAI.
The aim of this study is to evaluate whether the inclusion of uneven treadmill training in standard rehabilitation can improve clinical, functional, biomechanical, and patient-reported outcomes compared with the standard of care alone in service members with LAS and CAI. The prophylactic effects of treatment on secondary injury and identification of any contributing or mediating factors that influence outcomes following treatment will also be evaluated. We hypothesize that service members receiving uneven treadmill training will demonstrate greater improvements in clinical and instrumented measures of impairment, patient-reported function, and lower risk of injury recurrence than the control group immediately post and 18 months following treatment.
A multisite, parallel randomized clinical trial will be performed among service members aged 18-49 years being treated for LAS and CAI in military treatment facilities in the United States. Participants randomly assigned and allocated to receive the experimental intervention will be provided up to 12 sessions of training on an uneven terrain treadmill over a 6-week treatment course to supplement standard rehabilitation care. Treatment intensity of the rehabilitation exercises and treadmill training will be progressed on the basis of patient-perceived intensity and treatment responses. Outcome measures will include patient-reported outcomes, functional assessments, performance measures, and biomechanical measures. Investigators collecting outcome measures will be blinded to treatment allocation. Reinjury rates and patient-reported outcomes of function will be tracked over 18 months following treatment.
The project was funded in September 2020. Patient recruitment began in November 2021, with 3 participants enrolled as of February 2022. Dissemination of the main study findings is anticipated in 2024.
This study will assess the impact of an innovative uneven-terrain treadmill on treatment outcomes in the rehabilitation of service members with LAS and CAI. The results of this study will be used to inform rehabilitation practices and to potentially improve functional outcomes and secondary prevention in this patient population.
ClinicalTrials.gov NCT04999904; https://clinicaltrials.gov/ct2/show/NCT04999904?term=NCT04999904.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38442.
外侧踝关节扭伤（LAS）是军人中常见的损伤。约40%的LAS患者会发展为慢性踝关节不稳（CAI），这一状况会导致严重的机械和神经生理功能损害以及活动受限。由于本体感觉和平衡训练可改善功能结局并预防LAS后的二次损伤，因此在临床实践中被推荐使用。不平地面跑步机是一种创新方式，在执行模拟LAS和CAI军人经常遇到的环境的生态有效任务时，会对感觉运动系统构成挑战。
本研究旨在评估与仅接受标准护理相比，在标准康复治疗中加入不平地面跑步机训练是否能改善LAS和CAI军人的临床、功能、生物力学及患者报告结局。还将评估该治疗对二次损伤的预防作用以及确定影响治疗后结局的任何促成或中介因素。我们假设，接受不平地面跑步机训练的军人在治疗后即刻及治疗后18个月，在临床和仪器测量的功能损害、患者报告的功能方面将比对照组有更大改善，且再次受伤风险更低。
将在美国军事治疗机构中对年龄在18至49岁、正在接受LAS和CAI治疗的军人进行一项多中心、平行随机临床试验。被随机分配接受实验性干预的参与者将在为期6周的治疗过程中，在不平地面跑步机上接受多达12次训练，以补充标准康复护理。康复锻炼和跑步机训练的治疗强度将根据患者感知的强度和治疗反应进行调整。结局指标将包括患者报告结局、功能评估、性能测量和生物力学测量。收集结局指标的研究人员将对治疗分配情况不知情。治疗后将跟踪18个月的再受伤率和患者报告的功能结局。
该项目于2020年9月获得资助。患者招募于2021年11月开始，截至2022年2月有3名参与者入组。预计2024年公布主要研究结果。
本研究将评估一种创新的不平地面跑步机对LAS和CAI军人康复治疗结局的影响。本研究结果将用于为康复实践提供信息，并有可能改善该患者群体的功能结局和二级预防。
ClinicalTrials.gov NCT04999904；https://clinicaltrials.gov/ct2/show/NCT04999904?term=NCT04999904。
国际注册报告识别码（IRRID）：DERR1-10.2196/38442。
