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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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  • Participants will be withdrawn if they become pregnant during the course of the study.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.

United States1 site
  • Scottish Rite for Children

    Frisco, Texas, 75034

Other trials in United States

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 groups in NCT06983184
Study groupRoleWhat they receive
MC-Synced NTPExperimentalMenstrual cycle-synced neuromuscular training program
Receives: Other: MC-synced NTP
Blinded NTPActive comparatorBlinded neuromuscular training program
Receives: Other: Blinded NTP

What is being measured

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

  1. Attendance Rate

    Rate of attendance at training program

    Measured: From beginning to end of 8-week training program

  2. 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

  3. Participant feedback survey

    Participant feedback on training program through a 3-question participant questionnaire.

    Measured: From beginning to end of 8-week training program

  4. 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)
  1. AIMS Questionnaire

    Patient reported outcome questionnaire on self-perceptions about being an athlete

    Measured: 6 months, 1 year and 2 years post-training

  2. SNAC Nutrition Survey

    Patient reported outcome measure on athlete nutritional habits

    Measured: 6 months, 1 year and 2 years post-training

  3. 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.

  1. First posted21 May 2025
  2. Study start1 May 2025
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

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)
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

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.

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