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NCT04055129 · ClinicalTrials.gov registry record
Hormone Induced Effects on Ligament Laxity and Lower Extremity Motor Control
A clinical trial, sponsored by University of St. Augustine for Health Sciences.
- Completed
- Registry status
- 52
- Enrollment target
NCT04055129: Completed study, sponsored by University of St. Augustine for Health Sciences.
NCT04055129 is a clinical trial that has completed, run by University of St. Augustine for Health Sciences. The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04055129 has completed, sponsored by University of St. Augustine for Health Sciences.
- COMPLETED
- Registry status
- 52 participants
- Enrollment target
Study 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.
Primary Outcome
EMG recording to detect initiation of muscle activation for these muscles will be measured with EMG electrodes and software to detect when these muscles turn on and when they peak in their activity during a step down and jump activity.
Interventions
- OTHER No interventions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-11-17 |
| Est. Completion | 2023-08-01 |
What the finished NCT04055129 record still lists
NCT04055129 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which No interventions is the first listed.
NCT04055129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04055129 about?
NCT04055129 is a clinical study titled "Hormone Induced Effects on Ligament Laxity and Lower Extremity Motor Control". 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 cyc...
What is the current status of trial NCT04055129?
This trial is currently completed. The enrollment target is 52 participants. The study started on 2021-11-17. Estimated completion is 2023-08-01.
What interventions are being tested in trial NCT04055129?
The interventions under investigation include: No interventions (OTHER).
Who is sponsoring clinical trial NCT04055129?
This trial is sponsored by University of St. Augustine for Health Sciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
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