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Hormone Influence on Ligament Laxity and Motor ControlNCT04055129

Hormone Induced Effects on Ligament Laxity and Lower Extremity Motor Control

An observational study of Hormone Influence on Ligament Laxity and Motor Control, run by University of St. Augustine for Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Type of treatment
Pill or oral medicine
How many people
52 participants
Where
1 siteUnited States
Study dates
17 Nov 2021to 1 Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of St. Augustine for Health Sciences

    San Marcos, California, 92069

Other trials in United States

About this study

Official title: 17b-Estradiol Induced Effects on Anterior Cruciate Ligament Laxity, Lower Extremity Biomechanics and Neuromuscular Activation Patterns in Females During Landing Activities

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.

Read the 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 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. To ensure subject privacy, all investigators will be blinded to which group the subject is in during data collection except for the primary investigator who will do the initial meeting with the subjects to go through the informed consent, determine phase of menstrual cycle, and allocate the subject to a group based on their contraceptive use. From this point on, the subject will be identified by a subject number and all data intake and analysis will be done with the number identifier. Ovulation cycle will be identified by a self-administered ovulation kit, hormonal samples of Estrogen will be obtained by a saliva sample and sent to Salimetrics lab for analysis. Dependent measures will include recording subject single and double-leg jump off a 12- inch block and landing on a force plate to record muscle timing and ground reaction forces upon landing. Electromyography will be used to measure muscle activation timing of the quadriceps, hamstrings, gluteus maximus, gluteal medius, and gastrocnemius muscles. A 3-D measuring system will record trunk and hip flexion, femoral internal rotation angle, and knee flexion, extension and valgus angles. Finally, ligament laxity will be measured with a knee arthrometer (KT1000 or similar) device to record tibial anterior translation. Each subject will be tested, and each variable above will be recorded 2 separate times corresponding to 2 main phases in the menstrual cycle (Follicular and Ovulatory phases).

Being tested
No interventions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionsOther

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

Study groups in NCT04055129
Study groupRoleWhat they receive
Birth ControlHormone levels controlled with subject on birth control pill
Receives: Other: No interventions
Non-Birth ControlHormone (estrogen) levels not controlled but monitored for levels of estrogen at two points in menstrual cycle (Follicular and ovulatory phases)
Receives: Other: No interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: July 01, 2021

  2. 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

    Measured: July 01, 2021

Secondary outcomes (2)
  1. Knee valgus, femoral internal rotation angle, knee flexion and extension angles

    Lower extremity kinematics will be measured by using reflective markers and Simi 3D Motion capture system and markers to detect joint angle changes during a step down and jump activity (via computer software)

    Measured: July 01,2019

  2. Laxity of ACL/ anterior tibial excursion

    Anterior displacement of tibia on femur will be measured using the GNRB devive which measures anteior displacement in millimeters with a computer generated force (Newtons) and reading (MM)

    Measured: July 01, 2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2019
  2. Study start17 Nov 2021
  3. Primary completion1 Aug 2023
  4. Study completion1 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04055129
Sponsor's protocol ID
0430-018
Status last verified
Nov 2023
First submitted
8 Aug 2019
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hormone Influence on Ligament Laxity and Motor Control, run by University of St. Augustine for Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle activity for the following muscles: Quadriceps (vastus medialis and vastus lateralis), Hamstrings (semitendinosus, biceps femoris), gluteus maximus, gluteus medius, lateral gastrocnemius (time frame: July 01, 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.

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