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Clinical Trial Summary

chronic ankle instability previously approved in many studies that it may lead to more proximal adaptations and negative long term consequences. one of those studies reported, ankle instability patients has hamstring muscle shortening in comparison with non sprained subjects. another one concluded that gluteus maximums muscle has delayed activation and weakness in CAI patients. Both muscles (hamstring and gluteus Maximus ) contribute to sacroiliac joint stability. therefore, this study asked a novel research question, was sacroiliac joint dysfunction (SIJD) associated with CAI?

Clinical Trial Description

The sample size of this study had been calculated based on the primary outcome that was the association between CAI and SIJD after a pilot study done in order to detect odd's ratio. , calculation made by a program developed by the Centers for Disease Control and Prevention with the following inputting data : Two-sided confidence interval 95%, power 80%, ratio of controls to cases 1, percent of control exposed 4.5% , odds ratio 32%. The sample size calculations required for this study was 28 participants (14 in each group). Data distributions was checked for normality using Shapiro-Wilk test and for equality of variance using Box's test. Box and whiskers plots were used for detecting the outliers. Descriptive statistics calculated for demographic data. Intraclass correlation coefficients (ICC) and standard errors of measurement (SEM) were calculated to estimate the intratester reliability and precision of measurement for the static pelvic rotation The outcomes of these study were: 1. Association between CAI and SIJD represents through odd's ratio (primary outcome) 2. Pelvic torsion difference between CAI and control Calculated by Mann- Whitney test (secondary outcome) 3. Correlations between pelvic torsion with perceived ankle instability and number of giving way episodes calculated Pearson correlation coefficient(secondary outcome) Effect size analysis was calculated to determine the clinical significant difference. Statistical analysis was conducted using the statistical package for social studies (SPSS) for windows, version 24 (SPSS, Inc., Chicago, IL). The normative data presented as Mean ± standard deviation (SD) while non-normative data presented as median. Significance was set at p < 0.05 and total study power was set 80% ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04555083
Study type Observational
Source Cairo University
Status Completed
Start date January 3, 2020
Completion date November 30, 2020

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