How robust are clinical trials in primary and secondary ankle sprain prevention?

Objectives: Determine the statistical stability of RCTs examining primary and secondary prevention of ankle sprains. Methods: Databases were searched to August 2023. We included parallel design RCTs, using conservative interventions for preventing ankle sprain, reporting dichotomous injury event outcomes. Statistical stability was quantified using Fragility Index (FI) and Fragility Quotient (FQ). Subgroup analyses were undertaken to test if FI varied based on by study objective, original approach to analysis (frequency vs time to event), follow-up duration, and pre-registration. Results: 3559 studies were screened with 45 RCTs included. The median number of events required to change the statistical significance (FI) was 4 (IQR 1-6). FI was similar regardless of study objective, original analysis, follow-up duration, and pre-registration status. Median (IQR) FQ was 0.015 (0.005-0.046), therefore reversing events <2 patients/100 would alter significance. In 80% of studies the number of patients lost to follow-up was greater than the FI. Conclusion: RCTs informing primary and secondary prevention of ankle sprain are fragile. Only a small percentage of outcome event reversals would reverse study significance, and this is often exceeded by the number of drop outs. Robust reporting of dichotomous outcomes requires the use P values and key metrics such as FI or FQ

Impairment-based assessments for patients with lateral ankle sprain: A systematic review of measurement properties.

Study designSystematic review.Background and objectiveThe International Ankle Consortium developed a core outcome set for the assessment of impairments in patients with lateral ankle sprain (LAS) without consideration of measurement properties (MP). Therefore, the aim of this study is to investigate MPs of assessments for the evaluation of individuals with a history of LAS.MethodsThis systematic review of measurement properties follows PRISMA and COSMIN guidelines. Databases Pubmed, CINAHL, Embase, Web of Science, Cochrane Library and SPORTDiscus were searched for eligible studies (last search: July 2022). Studies on MP of specific tests and patient-reported outcome measurements (PROMs) in patients with acute and history of LAS (>4 weeks post injury) were deemed eligible.ResultsTen studies of acute LAS and 39 studies of history of LAS patients with a total of 3313 participants met the inclusion criteria. Anterior Drawer Test (ADT) in supine position five days post injury and Reverse Anterolateral Drawer Test are recommended in acute settings in single studies. In the history of LAS patients, Cumberland Ankle Instability Tool (CAIT) (4 studies) as a PROM, Multiple Hop (3 studies) and Star Excursion Balance Tests (SEBT) (3 studies) for dynamic postural balance testing showed good MPs. No studies investigated pain, physical activity level and gait. Only single studies reported on swelling, range of motion, strength, arthrokinematics, and static postural balance. Limited data existed on responsiveness of the tests in both subgroups.ConclusionThere was good evidence to support the use of CAIT as PROM, Multiple Hop, and SEBT for dynamic postural balance testing. Insufficient evidence exists in relation to test responsiveness, especially in the acute situation. Future research should assess MPs of assessments of other impairments associated with LAS

Rehabilitation strategies for lateral ankle sprain do not reflect established mechanisms of re-injury: A systematic review

Objectives: 1) determine the primary impairment addressed by each exercise included in exercise-based rehabilitation programs for patients with an acute ankle sprain; 2) Determine whether prescribed exercises incorporate complex tasks associated with ankle sprain injury mechanisms? Methods: We searched databases CINAHL, Web of Science, SPORTDiscus, Cochrane Register of Controlled Trials, PEDro, Google Scholar for RCT's including patients with acute ankle sprains, managed through exercise-based rehabilitation. Risk of bias was assessed by the Risk of Bias 2 tool. Exercises were analysed based on: the primary impairment(s) addressed; direction of movement; base of support; weightbearing status; flight phase. (PROSPERO: CRD42020210858) RESULTS: We included fourteen RCT's comprising 177 exercises. Neuromuscular function was addressed in 44% of exercises, followed by performance tasks (23%), and muscle strengthening (20%). Exercises were limited to movements across the sagittal plane (48%), with 31% incorporating multiplanar movements. Weight bearing exercises were almost divided equally between single-limb (59/122) and double leg stance exercises (61/122). Eighteen percent of all exercises incorporated a flight phase. Conclusions: Rehabilitation after LAS comprises simple exercises in the sagittal plane that do not reflect mechanisms of re-injury. Future interventions should incorporate more open chain joint position sense training, multiplanar single limb challenges, and jumping and landing exercises