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临床试验/NCT04555083
NCT04555083已完成不适用

Relationship Between Chronic Ankle Instability and Sacroiliac Joint Dysfunction

Cairo University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
odd's ratio of sacroiliac joint dysfunction

研究概览

简要总结

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?

详细描述

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%

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • young active people between 18-30 years old
  • CAI group has a self-report of a past history of unilateral ankle inversion injury since at least more than 1 year before the study onset
  • Required a period of protected weight bearing and/or immobilization at least one day
  • The patient reported a tendency to give way or repeatedly turn over during functional activity
  • At least 2 giving way episodes during the year before the study onset and/or recurrent ankle sprain
  • Perceived that the ankle was chronically weaker, more painful, and/or less functional than other non-injured ankle or than before first injury.
  • Positive anterior drawer test and /or talar tilt test

排除标准

  • Exclusion Criteria for both groups (CAI and Control )
  • Trunk asymmetry angle 5 - 7 degrees
  • Leg length difference more than 0.5 cm
  • History of autoimmune diseases, complains of ankylosing spondylitis and morning stiffness
  • Participation in physical therapy regimen within a year before enrolling in the study
  • Bilateral ankle sprain injury
  • Ankle sprain within 3 months of participation
  • If they had only midline or symmetrical pain above the level of L5 or radicular pain with neurological deficits (sensory or motor deficits)
  • History of spinal surgery, infection, tumors, fracture of the spine, pelvis or lower extremities within 2 years before enrolling in the study.
  • Hospitalization for severe trauma or car accident
  • Pregnant women
  • Any neurological and orthopedics diseases could affect the conditions

结局指标

主要结局

odd's ratio of sacroiliac joint dysfunction

时间窗: throughout the study about 1 year

association between CAI and sacroiliac joint dysfunction

次要结局

  • correlation between pelvic torsion and giving way episodes(throughout the study about one year)
  • corelation between pelvic torsion and perceived sensation of instability(throughout the study about 1 year)
  • difference of pelvic torsion between CAI and control(throughout the study about 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dalia Mohammad Mohammad Mosaad

Principal investigator

Cairo University

研究点 (1)

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