Hormone Induced Effects on Ligament Laxity and Lower Extremity Motor Control (NCT04055129) | Clinical Trial Compass
CompletedNot Applicable
Hormone Induced Effects on Ligament Laxity and Lower Extremity Motor Control
United States52 participantsStarted 2021-11-17
Plain-language 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 amount of research has previously been done on the effects of estrogen throughout the menstrual cycle on ligament laxity with some showing a correlation of increased estrogen levels with increased ligament laxity. There have also been several studies that investigated muscle activation and ground reaction forces as related to hormone levels and stages of the menstrual cycle. A recent systematic review found a lack of research investigating muscle activation timing as related to hormonal changes despite theories suggesting muscle function including timing could be an explanation as to the potential causes for increased ACL injury correlated with the luteal phase of the menstrual cycle. The aim of this study is therefore to investigate whether hormonal changes throughout the menstrual cycle correlate with changes in ligament laxity, motor control, muscle activation and timing.
This study will be a longitudinal controlled study with two groups both containing females ages 18-35 years of age. The subjects will be placed into either the Experimental Group (no birth control) or the Control Group (on birth control) depending on the status of their contraceptive use.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Muscle activity for the following muscles: Quadriceps (vastus medialis and vastus lateralis), Hamstrings (semitendinosus, biceps femoris), gluteus maximus, gluteus medius, lateral gastrocnemius
Timeframe: July 01, 2021
2
Ground Reaction Force
Timeframe: July 01, 2021
Trial details
NCT IDNCT04055129
SponsorUniversity of St. Augustine for Health Sciences