Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 1, 2022
Open Peer Review Period: Apr 1, 2022 - Apr 19, 2022
Date Accepted: Apr 28, 2022
(closed for review but you can still tweet)
Uneven treadmill training for rehabilitation of lateral ankle sprains and chronic ankle instability: a pragmatic randomized controlled trial
ABSTRACT
Background:
Lateral ankle sprains (LASs) are common injuries in 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.
Objective:
The aim of this study is to evaluate whether the inclusion of uneven treadmill training to standard rehabilitation can improve clinical, functional, biomechanical, and patient-reported outcomes compared with 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.
Methods:
A multi-site, parallel randomized clinical trial will be performed in 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 based on patient-perceived intensity and treatment response. 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.
Results:
The project was funded in September 2020. Patient recruitment began in November 2021, with 3 participants enrolled as of February 2022. Dissemination of main study findings is anticipated in 2024.
Conclusions:
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 potentially improve functional outcomes and secondary prevention in this patient population. Clinical Trial: ClinicalTrials.gov NCT04999904
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