ACL InjuriesNCT06983184
Menstrual Cycle-Synced Neuromuscular Training
A study testing MC-synced NTP and Blinded NTP in people with ACL Injuries, run by Sophia Ulman at 1 site in United States.
Trial summary
This is a research study of female athletes participating in at least one running/cutting sport, who have no current conditions that would limit ability to perform sport-like movement tasks (such as running or jumping), and have reported to be post-menarche (a regular period). Read more about this study
- Who is it for?
- Ages 13 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- ACL Injuries
- What is being tested?
- MC-synced NTP and Blinded NTP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy, female high school athlete who participate in running/pivoting sports (e.g., soccer and basketball)
- Aged 13-19 years
- Participants must also have a mobile phone, personally or via a parent, capable of downloading the Oura Ring app and of syncing to a wearable device via Bluetooth.
- Participants will not be excluded from participation if they report irregular periods (not a typical 28-day cycle) or use of hormonal birth control.
Who cannot join
- Participants will be excluded from enrollment if they:
- Have been diagnosed with any musculoskeletal or neuromuscular condition that would impact their movement patterns or training performance
- Report not yet starting their menses or not currently menstruating (no period in the prior 3 months).
- Females in the general student body who are not an active participant of the school's soccer or basketball program will be excluded from the study.
- Participants will be withdrawn if they become pregnant during the course of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is a research study of female athletes participating in at least one running/cutting sport, who have no current conditions that would limit ability to perform sport-like movement tasks (such as running or jumping), and have reported to be post-menarche (a regular period).
The purpose of this study is to leverage the menstrual cycle (MC) to improve the success of a neuromuscular training program (NTP) that has been shown to reduce high-risk movement patterns in adolescent females. The findings of this study may not only help develop more effective, personalized injury prevention strategies for female athletes, but may also have the potential to reduce ACL injury rates while improving long-term physical activity and health for active females.
Read more
The researchers hope that this information may help reduce ACL injury rates and enhance long-term musculoskeletal health in female athletes, while promoting greater equity in sports medicine and performance training.
Participants will be asked to wear an Oura Ring (a ring that is placed on a finger of the non-dominant hand) that will be used to track their menstrual cycle phases. The Oura Ring will be connected using a software called "Natural Cycles", which will sync to either a smart phone via Bluetooth, or data from the device can be downloaded to an iPad utilized by the research team. Participants will also take part in an 8-week Neuromuscular Training Program (NTP), that consists of two 30-minute training sessions per week, which will include dynamic exercises designed to improve strength and power, balance, and stability, as well as help to build a foundation of muscular endurance. Before starting the training program, participants will be asked to complete several questionnaires focused on activity level, sport participation characteristics, sport-related injury history, and menstrual cycle history, and both before and after completing the training program, participant movement patterns may be evaluated. For the training program, participants will be randomized into one of two groups - one that syncs the training type to the participant's menstrual cycle and one that does not. All participants will receive the same exercises, however, a participant's assigned group will determine when they receive certain exercises.
Participation in this study is completely voluntary. Participation is expected to last up to 7 months.
This is a minimal risk research study. There is a small risk of falling during movement tasks, skin irritation from tape that is used during movement evaluation, psychological stress from survey questions, and loss of confidentiality. To minimize these risks, participants may request rest breaks or stop participating at any time. Participants may also refuse to answer any questions that are asked, and all information collected from this research will be stored in a secure electronic database. This information known as "data" will not be shared with any person outside of the study team.
There is no benefit to participants who participate in this research study. However, the investigators hope the information gathered from this research may benefit others in the future.
- Conditions
- ACL Injuries
- Being tested
- MC-synced NTP, Blinded NTP
- Keywords
- ACL, menstruation, Neuromuscular training, female athlete
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC-synced NTPOther
Menstrual cycle-synced neuromuscular training program
Blinded NTPOther
Blinded neuromuscular training program
| Study group | Role | What they receive |
|---|---|---|
| MC-Synced NTP | Experimental | Menstrual cycle-synced neuromuscular training program Receives: Other: MC-synced NTP |
| Blinded NTP | Active comparator | Blinded neuromuscular training program Receives: Other: Blinded NTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance Rate
Rate of attendance at training program
Measured: From beginning to end of 8-week training program
Engagement Rate
Level of engagement throughout participation in training program as rated by the study team on a scale of "Very Dissatisfied" to "Very Satisfied".
Measured: From beginning to end of 8-week training program
Participant feedback survey
Participant feedback on training program through a 3-question participant questionnaire.
Measured: From beginning to end of 8-week training program
Biomechanical risk factors associated with ACL injury during dynamic, sport-related tasks
Changes in biomechanical risk factors associated with ACL injury during dynamic, sport-related tasks as evaluated through changes in motion capture analysis of six dynamic, sport-like tasks (step down tap, drop vertical jump, single leg hop, lateral shuffle, deceleration / plant, run-cut / change-of-direction).
Measured: From beginning to end of 8-week training program
Secondary outcomes (3)
AIMS Questionnaire
Patient reported outcome questionnaire on self-perceptions about being an athlete
Measured: 6 months, 1 year and 2 years post-training
SNAC Nutrition Survey
Patient reported outcome measure on athlete nutritional habits
Measured: 6 months, 1 year and 2 years post-training
PSQI Sleep Survey
Patient reported outcome measure on sleep habits
Measured: 6 months, 1 year and 2 years post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sophia Ulman
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Scottish Rite Hospital for Children
- Responsible party
- Sponsor-investigator, Sophia Ulman, Texas Scottish Rite Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983184
- Sponsor's protocol ID
- STU20250837
- Status last verified
- Jun 2026
- First submitted
- 25 Apr 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menstrual Cycle-Synced Neuromuscular Training
- ClinicalTrials.gov ID
- NCT06983184
- Acronym / sponsor ID
- STU20250837
- Conditions
- ACL Injuries
- Keywords
- ACL, menstruation, Neuromuscular training, female athlete
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Sophia UlmanUniversity, hospital or other
- Collaborators
- Texas Scottish Rite Hospital for Children
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 21 May 2025 (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.
This is a research study of female athletes participating in at least one running/cutting sport, who have no current conditions that would limit ability to perform sport-like movement tasks (such as running or jumping), and have reported to be post-menarche (a regular period).
The purpose of this study is to leverage the menstrual cycle (MC) to improve the success of a neuromuscular training program (NTP) that has been shown to reduce high-risk movement patterns in adolescent females. The findings of this study may not only help develop more effective, personalized injury prevention strategies for female athletes, but may also have the potential to reduce ACL injury rates while improving long-term physical activity and health for active females.
The researchers hope that this information may help reduce ACL injury rates and enhance long-term musculoskeletal health in female athletes, while promoting greater equity in sports medicine and performance training.
Participants will be asked to wear an Oura Ring (a ring that is placed on a finger of the non-dominant hand) that will be used to track their menstrual cycle phases. The Oura Ring will be connected using a software called "Natural Cycles", which will sync to either a smart phone via Bluetooth, or data from the device can be downloaded to an iPad utilized by the research team. Participants will also take part in an 8-week Neuromuscular Training Program (NTP), that consists of two 30-minute training sessions per week, which will include dynamic exercises designed to improve strength and power, balance, and stability, as well as help to build a foundation of muscular endurance. Before starting the training program, participants will be asked to complete several questionnaires focused on activity level, sport participation characteristics, sport-related injury history, and menstrual cycle history, and both before and after completing the training program, participant movement patterns may be evaluated. For the training program, participants will be randomized into one of two groups - one that syncs the training type to the participant's menstrual cycle and one that does not. All participants will receive the same exercises, however, a participant's assigned group will determine when they receive certain exercises.
Participation in this study is completely voluntary. Participation is expected to last up to 7 months.
This is a minimal risk research study. There is a small risk of falling during movement tasks, skin irritation from tape that is used during movement evaluation, psychological stress from survey questions, and loss of confidentiality. To minimize these risks, participants may request rest breaks or stop participating at any time. Participants may also refuse to answer any questions that are asked, and all information collected from this research will be stored in a secure electronic database. This information known as "data" will not be shared with any person outside of the study team.
There is no benefit to participants who participate in this research study. However, the investigators hope the information gathered from this research may benefit others in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MC-Synced NTP | Experimental | Other: MC-synced NTPMenstrual cycle-synced neuromuscular training program |
| Blinded NTP | Active comparator | Other: Blinded NTPBlinded neuromuscular training program |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Healthy, female high school athlete who participate in running/pivoting sports (e.g., soccer and basketball)
- Aged 13-19 years
- Participants must also have a mobile phone, personally or via a parent, capable of downloading the Oura Ring app and of syncing to a wearable device via Bluetooth.
- Participants will not be excluded from participation if they report irregular periods (not a typical 28-day cycle) or use of hormonal birth control.
Key exclusion criteria (5 listed)
- Have been diagnosed with any musculoskeletal or neuromuscular condition that would impact their movement patterns or training performance
- Report not yet starting their menses or not currently menstruating (no period in the prior 3 months).
- Females in the general student body who are not an active participant of the school's soccer or basketball program will be excluded from the study.
- Participants will be withdrawn if they become pregnant during the course of the study.
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 |
|---|---|---|
| MC-synced NTPMenstrual cycle-synced neuromuscular training program | Other | MC-Synced NTP |
| Blinded NTPBlinded neuromuscular training program | Other | Blinded NTP |
Primary outcome
Attendance Rate
Time frame: From beginning to end of 8-week training program
Rate of attendance at training program
Engagement Rate
Time frame: From beginning to end of 8-week training program
Level of engagement throughout participation in training program as rated by the study team on a scale of "Very Dissatisfied" to "Very Satisfied".
Participant feedback survey
Time frame: From beginning to end of 8-week training program
Participant feedback on training program through a 3-question participant questionnaire.
Biomechanical risk factors associated with ACL injury during dynamic, sport-related tasks
Time frame: From beginning to end of 8-week training program
Changes in biomechanical risk factors associated with ACL injury during dynamic, sport-related tasks as evaluated through changes in motion capture analysis of six dynamic, sport-like tasks (step down tap, drop vertical jump, single leg hop, lateral shuffle, deceleration / plant, run-cut / change-of-direction).
3 secondary outcomes
AIMS Questionnaire
Time frame: 6 months, 1 year and 2 years post-training
SNAC Nutrition Survey
Time frame: 6 months, 1 year and 2 years post-training
PSQI Sleep Survey
Time frame: 6 months, 1 year and 2 years post-training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MC-synced NTP and Blinded NTP in people with ACL Injuries, run by Sophia Ulman 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 4 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 1 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Attendance Rate (time frame: From beginning to end of 8-week training program). The study lists 4 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 1 Jul 2026.