Dataset Information

Uneven Treadmill Training for Rehabilitation of Lateral Ankle Sprains and Chronic Ankle Instability: Protocol for a Pragmatic Randomized Controlled Trial.

ABSTRACT:

Background

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.

Objective

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.

Methods

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.

Results

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.

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 to potentially improve functional outcomes and secondary prevention in this patient population.

Trial registration

ClinicalTrials.gov NCT04999904; https://clinicaltrials.gov/ct2/show/NCT04999904?term=NCT04999904.

International registered report identifier (irrid)

DERR1-10.2196/38442.

SUBMITTER: Russell Esposito E

PROVIDER: S-EPMC9260521 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundAnkle sprains are one of the most prevalent soft-tissue injuries worldwide. Physical therapy, especially progressive exercise, has proven effective in improving function, while preventing recurrence.ObjectiveWe aim to present the results of a fully remote and digitally guided rehabilitation program for acute ankle sprains.MethodsWe performed a prospective longitudinal cohort study of individuals eligible for workers' compensation, who were referred for digital rehabilitation therapy for a sprained ankle. Therapeutic exercise sessions were to be performed independently by the patient at home using the biofeedback device provided by SWORD Health. Primary endpoints were the change in self-reported Numerical Pain Rating Scale (NPRS) and Foot and Ankle Ability Measure-activities of daily living (FAAM-ADL) and FAAM-Sports scores. Participants were assessed at baseline, end of the program, and 6 months after program completion. Secondary outcomes included digital therapy dosage, pain and fatigue during sessions, and satisfaction.ResultsIn total, 93 (89.4%) patients completed the program and 79 (76.0%) were available for follow-up. Changes in the primary outcomes between baseline and the 6-month follow-up were both significant (P<.001) and clinically meaningful: mean difference of -2.72 points (95% CI -3.31 to -2.13) on the NPRS (49.8% reduction), 21.7 points (95% CI 17.13-26.27) on the FAAM-ADL (41.1% increase), and 37.8 points (95% CI 30.45-45.15) on the FAAM-Sports (151.8% increase). Longer waiting periods between the accident date and treatment initiation were found to negatively impact functional status at baseline and at the end of the program, triggering an extension in the program duration. The total training volume (12.5 hours, SD 10.5 hours) was similar to that of other interventions for ankle sprains, but the dosage per week was much higher (2.4 hours per week, SD 0.87 hours per week). The mean patient satisfaction score was 8.8 (SD 1.57) out of 10. Among program completers, 83.9% attained full recovery and were discharged with no residual disability.ConclusionsBeing far less demanding in terms of human resources, the digital program presented constituted a viable, clinically effective, and convenient solution for ankle sprain rehabilitation, particularly during the pandemic. This is the first study presenting a fully remote home-based rehabilitation program for acute ankle sprains, with patients achieving sustained long-term results. This was a prospective cohort study and, as such, did not include a control group, but the results appear comparable to those published for face-to-face interventions.Trial registrationClinicalTrials.gov NCT04819022; https://clinicaltrials.gov/ct2/show/NCT04819022.

Project description:ContextResearchers have shown that rehabilitation programs incorporating resistance-band and balance-board exercises are effective for improving clinical measures of function and patient-reported outcomes in individuals with chronic ankle instability (CAI). However, whether combining the 2 exercises increases improvement is unknown.ObjectiveTo determine the effectiveness of 3 rehabilitation programs on clinical measures of balance and self-reported function in adolescent patients with CAI.DesignRandomized controlled clinical trial (Trail Registration Number: ClinicalTrails.gov: NCT03447652).SettingHigh school athletic training facilities.Patients or other participantsForty-three patients with CAI (age = 16.37 ± 1.00 years, height = 171.75 ± 12.05 cm, mass = 69.38 ± 18.36 kg) were block randomized into 4 rehabilitation groups.Intervention(s)Protocols were completed 3 times per week for 4 weeks. The resistance-band group performed 3 sets of 10 repetitions of ankle plantar flexion, dorsiflexion, inversion, and eversion with a resistance band. The Biomechanical Ankle Platform System group performed 5 trials of clockwise and counterclockwise rotations, changing direction every 10 seconds during each 40-second trial. The combination group completed resistance-band and Biomechanical Ankle Platform System programs during each session. The control group did not perform any exercises.Main outcome measure(s)Variables were assessed before and after the intervention: time-in-balance test, foot-lift test, Star Excursion Balance Test, side-hop test, figure-8 hop test, Foot and Ankle Ability Measure, and Cumberland Ankle Instability Tool. We conducted 4 separate multivariate repeated-measures analyses of variance, followed by univariate analyses for any findings that were different.ResultsUsing the time-in-balance test, foot-lift test, Star Excursion Balance Test (medial, posteromedial, and posterolateral directions), and figure-8 hop test, we detected improvement for each rehabilitation group compared with the control group (P < .05). However, no intervention group was superior.ConclusionsAll 3 rehabilitation groups demonstrated improvement compared with the control group, yet the evidence was too limited to support a superior intervention. Over a 4-week period, either of the single-task interventions or the combination intervention can be used to combat the residual deficits associated with CAI in an adolescent patient population.

Project description:BackgroundAcute lateral ankle sprains (LAS) account for 4-5% of all Emergency Department (ED) visits. Few patients receive the recommended care of exercise rehabilitation. A simple solution is an exercise app for mobile devices, which can deliver tailored and real-time adaptive exercise programs.PurposeThe purpose of this pilot study was to investigate the use and preliminary effect of an app-based exercise program in patients with LAS seen in the Emergency Department at a public hospital.Materials and methodsWe used an app that delivers evidence-based exercise rehabilitation for LAS using algorithm-controlled progression. Participants were recruited from the ED and followed for four months. Data on app-use and preliminary effect were collected continuously through the exercise app and weekly text-messages. Baseline and follow-up data were collected though an online questionnaire. Semi-structured interviews were performed after participants stopped using the app. Results: Health care professionals provided 485 patients with study information and exercise equipment. Of those, 60 participants chose to enroll in the study and 43 became active users. The active users completed a median of 7 exercise sessions. Most of the active users were very satisfied or satisfied (79%-93%) with the app and 95.7% would recommend it to others. The interviews showed that ankle sprains were considered an innocuous injury that would recover by itself. Several app users expressed they felt insufficiently informed from the ED health care professionals. Only 39% felt recovered when they stopped exercising, and 33% experienced a recurrent sprain in the study period. Conclusion: In this study, only few patients with LAS became active app users after receiving information in the ED about a free app-based rehabilitation program. We speculate the reason for this could be the perception that LAS is an innocuous injury. Most of the patients starting training were satisfied with the app, although few completed enough exercise sessions to realistically impact clinical recovery. Interestingly more than half of the participants did not feel fully recovered when they stopped exercising and one third experienced a recurrent sprain.Trial-identifiershttps://clinicaltrials.gov/ct2/show/NCT03550274, preprint (open access): https://www.medrxiv.org/content/10.1101/2022.01.31.22269313v1.

Project description:BACKGROUND:A key point to surgical treatment of chronic lateral ankle instability is choosing a suitable surgical procedure. The purpose of this meta-analysis was to compare different surgical techniques for management of chronic lateral ankle instability. METHODS:We searched the Cochrane Library, MEDLINE, and EMBASE. All identified randomized and quasi-randomized controlled trials of operative treatment for chronic lateral ankle instability were included. Two review authors independently extracted data from each study and assessed risk of bias. Where appropriate, results of comparable studies were pooled. RESULTS:Seven randomized controlled trials were included for analysis. They fell in five clearly distinct groups. One study comparing two different kinds of non-anatomic reconstruction procedures (dynamic and static tenodesis) found two clinical outcomes favoring static tenodesis: better clinical satisfaction and fewer subsequent sprains. Two studies compared non-anatomic reconstruction versus anatomic repairment. In one study, nerve damage was more frequent in non-anatomic reconstruction group; the other one reported that radiological measurement of ankle laxity showed that non-anatomic reconstruction provided higher reduction of talar tilt angle. Two studies comparing two anatomic repairment surgical techniques (transosseous suture versus imbrication) showed no significant difference in any clinical outcome at the follow-up except operation time. One study compared two different anatomic repairment techniques. They found that the double anchor technique was superior with respect to the reduction of talar tilt than single anchor technique. One study compared an anatomic reconstruction procedure with a modified Brostrom technique. Primary reconstruction combined with ligament advanced reinforcement system results in better patient-scored clinical outcome, at 2 years post-surgery, than the modified Brostrom procedure. CONCLUSIONS:There is limited evidence to support any one surgical technique over another surgical technique for chronic lateral ankle instability, but based on the evidence, we could still get some conclusions: (1) There are limitations to the use of dynamic tenodesis, which obtained poor clinical satisfaction and more subsequent sprains. (2) Non-anatomic reconstruction abnormally increased inversion stiffness at the subtalar level as compare with anatomic repairment. (3) Multiple types of modified Brostrom procedures could acquire good clinical results. (4) Anatomic reconstruction is a better procedure for some specific patients.