Status:
COMPLETED
Hormone Induced Effects on Ligament Laxity and Lower Extremity Motor Control
Lead Sponsor:
University of St. Augustine for Health Sciences
Conditions:
Hormone Influence on Ligament Laxity and Motor Control
Eligibility:
FEMALE
18-35 years
Brief Summary
The purpose of this study is to expand on previous knowledge of the hormonal effects, specifically estrogen, on ligament laxity, motor control and timing of muscle activation in females. A significant...
Detailed Description
The purpose of this study is to expand on previous knowledge of the hormonal effects, specifically estrogen, on ligament laxity, motor control and timing of muscle activation in females. A significant...
Eligibility Criteria
Inclusion
- Female
- Age 18-35 years of age
- Group A) Not on Oral Contraceptive Group (NOC):
- Regular menstrual cycle for a minimum of 2 consecutive months
- No oral contraceptive birth control for a minimum of 6 months.
- Group B) Oral Contraceptive Group (OC):
- Currently on oral hormone-based contraceptive intended to cease ovulation)
Exclusion
- Previous lower extremity or spine injury
- Complaint of knee pain within past 6 months
- Irregular menstrual cycle (not consistently following a 28-32 cycle for a minimum of 2 months)
- Unable to meet physical demands of testing criterion:
- Forward jump off 12- inch height step both legs and then single leg
- Assume single leg-stance
- Adhesive/electrode allergy
- Pain or report of discomfort with any testing
- Unable to produce saliva sample
- Taking hormone replacements or medications known to cross-react with saliva sample and potentially give false data results (Fulvestrant/ Faslodex)
- History of pregnancy
- Smoker
- BMI \>25
- Thyroid issues
- Connective tissue diseases (such as Ehlers-Danlos Syndrome, Marfan's Disease, Rheumatoid Arthritis)
- Excessive laxity of ACL (greater than 3 mm side to side anterior laxity measure on knee arthrometer)
Key Trial Info
Start Date :
November 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04055129
Start Date
November 17 2021
End Date
August 1 2023
Last Update
November 28 2023
Active Locations (1)
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1
University of St. Augustine for Health Sciences
San Marcos, California, United States, 92069