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.
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
- Conditions the study is for
- Hormone Influence on Ligament Laxity and Motor Control
- 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
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 group | Role | What they receive |
|---|---|---|
| Birth Control | Hormone levels controlled with subject on birth control pill Receives: 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) Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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.
- First posted13 Aug 2019
- Study start17 Nov 2021
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Influence on Ligament Laxity and Motor ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of St. Augustine for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kayla Smith PT, MSPT, DSc, University of St. Augustine for Health Sciences
- Investigators
- Kayla M Smith, Dsc, Principal investigator, University of St. Augustine for Health Sciences
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 17b-Estradiol Induced Effects on Anterior Cruciate Ligament Laxity, Lower Extremity Biomechanics and Neuromuscular Activation Patterns in Females During Landing Activities
- ClinicalTrials.gov ID
- NCT04055129
- Acronym / sponsor ID
- 0430-018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of St. Augustine for Health SciencesUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Birth Control | – | Other: No interventionsHormone levels controlled with subject on birth control pill |
| Non-Birth Control | – | Other: No interventionsHormone (estrogen) levels not controlled but monitored for levels of estrogen at two points in menstrual cycle (Follicular and ovulatory phases) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 52 healthy females (26 on birth control, 26 not on birth control), with healthy knees aged 18-35 years old.
Key inclusion criteria (7 listed)
- Female
- Age 18-35 years of age
- Group A) Not on Oral Contraceptive Group (NOC):
- Group B) Oral Contraceptive Group (OC):
Key exclusion criteria (16 listed)
- 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:
- History of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsObservational. Data will be gathered and analyzed on ligament laxity, EMG, kinetics and kinematics during a landing and jumping activity | Other | Birth Control, Non-Birth Control |
Primary outcome
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
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.
Ground Reaction Force
Time frame: July 01, 2021
A force plate and computer program will be used to detect the ground reaction forces during a step down and jump activity
2 secondary outcomes
Knee valgus, femoral internal rotation angle, knee flexion and extension angles
Time frame: July 01,2019
Laxity of ACL/ anterior tibial excursion
Time frame: July 01, 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kayla M Smith, Dsc principal investigator
University of St. Augustine for Health Sciences
1 site in 1 country: see every site and its status.
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.