- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04555083
Association Between Chronic Ankle Instability and Sacroiliac Joint Dysfunction
Relationship Between Chronic Ankle Instability and Sacroiliac Joint Dysfunction
Study Overview
Status
Conditions
Detailed 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:
- Association between CAI and SIJD represents through odd's ratio (primary outcome)
- Pelvic torsion difference between CAI and control Calculated by Mann- Whitney test (secondary outcome)
- 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Giza
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Dokki, Giza, Egypt, 12555
- Afaf Tahoon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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CAI group
Case group is CAI group that recruit patients complain of ankle insatiability and giving way mainly
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control group
control group recruits participants with non injured ankle, matched with case group in gender and dominant limb
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
odd's ratio of sacroiliac joint dysfunction
Time Frame: throughout the study about 1 year
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association between CAI and sacroiliac joint dysfunction
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throughout the study about 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
difference of pelvic torsion between CAI and control
Time Frame: throughout the study about 1 year
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pelvic torsion is pelvic asymmetry in sagittal plane
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throughout the study about 1 year
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correlation between pelvic torsion and giving way episodes
Time Frame: throughout the study about one year
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giving way episodes throughout the previous year and pelvic torsion by inclinometer
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throughout the study about one year
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corelation between pelvic torsion and perceived sensation of instability
Time Frame: throughout the study about 1 year
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pelvic torsion by inclinometer and perceived instability sensation through visual analogue scale, ranged from 0-10 with high score means worse result
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throughout the study about 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dalia mossad, professor, professor at faculty of physical therapy Cairo university
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/002302
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sacroiliac Joint Dysfunction
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Najran UniversityCompletedSacroiliac Joint DysfunctionSaudi Arabia, India
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Mahmoud Yousry Rashwan HefnyRecruitingSacroiliac Joint DysfunctionEgypt
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Istanbul Medipol University HospitalCompletedSacroiliac Joint DysfunctionTurkey
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Alabama Physical Therapy & AcupunctureUniversidad Rey Juan CarlosCompletedSacroiliac Joint DysfunctionUnited States