Hormone Induced Effects on Ligament Laxity and Lower Extremity Motor Control

NCT04055129 | Completed

• 1 other identifier: 0430-018
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hormone Influence on Ligament Laxity and Motor Control

Outcome Measures

Primary Outcomes (2)

• Muscle activity for the following muscles: Quadriceps (vastus medialis and vastus lateralis), Hamstrings (semitendinosus, biceps femoris), gluteus maximus, gluteus medius, lateral gastrocnemius

  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.

  July 01, 2021

• Ground Reaction Force

  A force plate and computer program will be used to detect the ground reaction forces during a step down and jump activity

  July 01, 2021

Secondary Outcomes (2)

• Knee valgus, femoral internal rotation angle, knee flexion and extension angles

  July 01,2019

• Laxity of ACL/ anterior tibial excursion

  July 01, 2019

Study Arms (2)

Birth Control

Hormone levels controlled with subject on birth control pill

Other: No interventions

Non-Birth Control

Hormone (estrogen) levels not controlled but monitored for levels of estrogen at two points in menstrual cycle (Follicular and ovulatory phases)

Other: No interventions

Interventions

No interventions OTHER

Observational. Data will be gathered and analyzed on ligament laxity, EMG, kinetics and kinematics during a landing and jumping activity

Birth Control; Non-Birth Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: 26 females on birth control, 26 not on birth control
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

52 healthy females (26 on birth control, 26 not on birth control), with healthy knees aged 18-35 years old.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of St. Augustine for Health Sciences: lead

Study Sites (1)

University of St. Augustine for Health Sciences

San Marcos, California, 92069, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva samples to be frozen and sent to lab for amount of estrogen analysis

Study Officials

• Kayla M Smith, Dsc

  University of St. Augustine for Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of St. Augustine for Health Sciences

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 13, 2019
• Study Start: November 17, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)