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Concussion, BrainNCT06473883

The Impact of Eye and Body Training on the Injury Rate of Concussions in Female Soccer Players

A study testing Training recommendation in people with Concussion, Brain and Musculoskeletal Pain, run by BrainCare Medical Group.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The research project aims to find out how special training influences the frequency and severity of injuries among female footballers in the top Swiss league. The project also aims to help establish normative values that are specifically tailored to women. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Concussion, Brain, Musculoskeletal Pain
What is being tested?
Training recommendation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
209 participants
Where
No sites listed yet
Study dates
30 Jun 2024to 30 Sep 2025
Phase
Interventional
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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Registered player for a club in the top Swiss soccer league
  • No symptoms of acute head injury at the start of the study
  • Sufficient language skills to understand the study information and the informed consent form and to answer questionnaires and anamnestic questions correctly.

Who cannot join

  • Symptomatic chronic diseases (e.g. tumor diseases, diabetes mellitus, cardiovascular diseases) with the exception of osteoarthritis and controlled (normotensively controlled) arterial hypertension
  • Pregnancy
  • Diagnosis of a psychiatric disorder/disease
  • Drug abuse
  • For the neuropsychological test: Known learning disability/disorder

Trial locations and contacts

No sites are listed yet.

Nina Feddermann-Demont, PD Dr. med contact

+41 44 500 41 50

daniel.agostino@braincare.swiss

About this study

Official title: Effects of Vestibulo-oculomotor and Neuromuscular Training on the Incidence of Concussions and Musculoskeletal Injuries in Competitive Female Football Players

The research project aims to find out how special training influences the frequency and severity of injuries among female footballers in the top Swiss league. The project also aims to help establish normative values that are specifically tailored to women. The participating clubs will be randomly assigned to a comprehensive pre-season baseline examination with training recommendations based on the performed examinations (intervention group) or control group (normal training). Over the course of the 2024/2025 season, both groups will be compared in terms of the incidence and severity of concussions and musculoskeletal injuries. Initial results will be available in spring 2025 to coincide with the start of the European Women's Football Championship.

The investigators' hypothesis is that the training recommendations in the intervention group will lead to a lower incidence of concussions and that the players will show better injury prevention as a result of these exercises.

Read the detailed description

All clubs in the top women's league in football will be contacted and asked to take part in the study. The baseline examinations will ideally take place in June and August 2024 to allow sufficient time to implement the training recommendations. The baseline examinations include a range of assessments addressing various systems potentially impacted by a concussion. These assessments encompass a standardized questionnaire, as well as vestibular, neurocognitive, balance, neck, and neurological evaluations.

Due to the availability of the players, baseline examinations may also have to take place in September. The players in the intervention group are also given specific training recommendations for the prevention of head injuries, which are compiled by experts (neurologists, sports scientists, physiotherapists and neuroscientists). The exercise selection covers several areas that can be affected after a head injury. Each section contains 8 different exercises with increasing levels of difficulty (3x Basic-3x Intermediate-2x Advanced). The recommendations should be used as a warm-up program throughout the season before each training session. The coach or athletic coach will lead the warm-up program and ensure that each player follows the sequence and completes each phase according to the scheduled weeks. The warm-up program should be conducted as an 8-week cycle.

The exercises are sent to the coaching staff in writing and by means of a video using our Neuroreha-Tool app. The coaches have access to the specific prescribed exercises. Each exercise is repeated 2-3 times and each exercise takes 50 seconds. In total, the warm-up will take 10-15 minutes.

During the football season from August 2024 to April 2025, players (both intervention and control groups) will be asked every two weeks to submit information about any injuries sustained in the match via the My REDCap app or the REDCap online survey. In the event of an injury, the date, type, and injured body region will be recorded via REDCap. Training adherence will also be documented for both groups (intervention group: number of training minutes for specific vestibulo-oculomotor and/or neuromuscular training exercises; control group: minutes of regular training).

After 8 weeks, a follow-up of the standard baseline tests will be repeated to measure the effects of the training recommendations. Each player receives a short report on the results of their examination within one week of the follow-up examination.

If a player suffers a concussion, they will be asked to complete the post-concussion symptom scale (PCSS). Players can also indicate if they wish to be contacted by the BrainCare institute for targeted diagnostics and/or therapy. On the day of the baseline examination, players will be thoroughly informed about the definition and correct recording of all endpoints collected in the follow-up. This information will also be available online on the app at any time. A recently published study confirms the usefulness and user-friendliness of a mobile app for monitoring training adherence and assessing pain using a pain rating scale.

Once a month, the club's contact person - ideally a member of the medical team who was also present at the baseline test - is contacted by the project management to verify the information and record the severity (i.e. the number of days the player is out of action) of injuries. The number of match appearances played (in hours) is determined using Power BI from the Swiss Football Association (football.ch).

Being tested
Training recommendation
Medical subject headings
Brain Concussion, Musculoskeletal Pain

What participants receive

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

  • Training recommendationOther

    The players in the intervention group are also given specific training recommendations for the prevention of head injuries, which are compiled by experts (sports scientists, physiotherapists and neuroscientists). The exercise selection covers several areas that can be affected after a head injury. Each section contains 8 different exercises with increasing levels of difficulty (3x Basic-3x Intermediate-2x Advanced). The recommendations should be used as a warm-up program throughout the season before each training session. The coach or athletic coach will lead the warm-up program and ensure that each player follows the sequence and completes each phase according to the scheduled weeks. The warm-up program should be conducted as an 8-week cycle.

Study groups in NCT06473883
Study groupRoleWhat they receive
Training recommendationExperimentalThe intervention group will receive training recommendations to prevent concussions and other injuries and improve their performance.
Receives: Other: Training recommendation
Normal trainingNo interventionThe control group will continue with their regular training without any recommendations for the prevention of head injuries.

What is being measured

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

  1. Incidence of injury frequency

    Injury frequency will be gauged via REDCap questionnaires, capturing date, type, and injured region. Training adherence will be noted: the intervention group reports specific vestibulo-oculomotor and/or neuromuscular exercise minutes, while the control group reports normal training minutes. Concussed players complete the Post-Concussion Symptom Scale (PCSS). The PCSS is designed to quantify the range and severity of symptoms that can occur after a concussion. It helps healthcare professionals monitor changes in symptoms over time and make informed decisions about an individual's recovery and readiness to return to activities.Each symptom is rated on a scale, typically from 0 to 6, where 0 means the symptom is not present and 5-6 indicates severe severity.

    Questionnaires occur at baseline, 8-week follow-up, and biweekly until season end for all players.

    Measured: 1 year

Secondary outcomes (16)
  1. Clinical cervical spine/jaw exam:

    The examination of the cervical spine and the surrounding tissue is used to identify cervical causes of headaches. Assessments include range of motion (degrees) and isometric strength (N) for the cervical spine, and extent of movement and deviation of mouth opening (degrees) for the jaw.

    Measured: 1 year

  2. Video-Head Impulse Test (vHIT)

    Passive, fast and low-amplitude rotational movements (head impulses, 10-15° eccentricity) are performed in the planes of each pair of semicircular canals (horizontal, RALP (right front-left rear), LARP (left front-right rear)) and induce VOR responses. During the examination, the subject is asked to fixate a target straight ahead. The eye movements during the VOR are measured with a high-speed video camera.

    Evaluation of gain (ratio between head and eye movement) and presence of saccades (rapid, corrective eye movements) are measured.

    Measured: 1 year

  3. Dynamic Visual Acuity (DVA)

    During the DVA, visual acuity is determined during head movements in order to measure the effectiveness of the visual stabilization function. Static visual acuity (visual acuity without head movement) is determined by reducing the size of a Landolt with C on a computer screen until the athlete is no longer able to read it correctly. The visual acuity is then obtained with head movements (120°/s, ±30°). If the difference between the static and dynamic visual acuity is more than 0.2 logMAR, there is a visual stabilization disorder.The difference between static and dynamic visual acuity is assessed in logMAR.

    Measured: 1 year

  4. Vestibulo/Oculomotor Screening (VOMS)

    The VOMS tests eye movements and vestibulo-oculomotor coordination. The screening covers five areas: Smooth pursuit, horizontal and vertical saccades, near convergence distance, horizontal vestibular eye reflex and visual motion sensitivity. For each area, the symptoms are rated on a Visual analogue scale (VAS), typically from 0 to 10, where 0 means the symptom is not present and 8-10 indicates severe severity. The near point convergence distance is measured in centimeters (cm).

    Measured: 1 year

  5. Modified Balance Error Scoring System-Test (BESS)

    BESS is a reliable and inexpensive tool to measure static balance. BESS consists of 6 tests that include both leg stance, one leg stance and tandem stance conditions, respectively, on both hard and foam surfaces with eyes closed. A stopwatch is used to determine participants' time during 20-second stance tests. The grading method is based on the score of the error table in the six tests. Errors include lifting the hip, walking, opening the eyes, grasping something, falling, leaving the test position after 5 seconds, flexion or abduction of the upper leg more than 30 degrees, and lifting the heel or front of the leg on the surface. If more than one mistake is made at the same time, they are counted as one mistake. The maximum total number of errors for any test is taken to be 10 (a higher score indicates mor balance errors and greater balance impairment).

    Measured: 1 year

  6. Dual Task - Concussion Balance Test (COBALT)

    The COBALT assesses balance through 5 conditions: 1 single-task and 4 dual-task. Participants are timed for 20 seconds using a stopwatch. In the single-task, they count backwards by 7s from 100. Dual-task conditions combine balance exercises with the cognitive task, with and without foam:

    1. Double leg stance with eyes closed, head rotating side to side to a metronome at 120 bpm.
    2. Eyes open, arms outstretched, thumbs up, focusing on thumbs while rotating side to side to a metronome at 40 bpm.

    Scoring uses an error table across conditions. Errors include cognitive mistakes, hip lifting, walking, eye opening, grasping, falling, leaving position early, leg movement beyond 30 degrees, and not syncing head or trunk rotation with the metronome. Each test's maximum errors are 10, with higher scores indicating more balance issues and impairment.

    Measured: 1 year

  7. Postural Control - Sway path length

    Sway path length measurement using an accelerometer involves tracking the movement of the center of pressure (COP) during the BESS and COBALT. This measure provides an objective assessment of postural control by quantifying the total distance the COP travels. An accelerometer is placed on the hip to capture the body's movements, and the data is analyzed using specialized balance software. The sway path length is measured in millimeters (mm).

    Measured: 1 year

  8. Postural Control - sway path velocity

    Sway path velocity measurement involves quantifying the speed at which the center of pressure (COP) moves. This parameter provides an objective assessment of postural control by indicating how quickly the COP travels. An accelerometer is placed on the hip to capture the body's movements, and the data is analyzed using specialized balance software. The measure is performed during the BESS and COBALT. The sway path velocity is measured in millimeters per seconds (mm/s).

    Measured: 1 year

  9. Latency in horizontal saccades

    Saccade latency in milliseconds (ms) during horizontal paradigms. The participant sits in front of a computer screen displaying a moving symbol, which they must follow without moving their head. Eye movements are recorded and analyzed using an eye-tracking device.

    Measured: 1 year

  10. Latency in vertical saccades

    Saccade latency in milliseconds (ms) during vertical paradigms. The participant sits in front of a computer screen displaying a moving symbol, which they must follow without moving their head. Eye movements are recorded and analyzed using an eye-tracking device.

    Measured: 1 year

  11. Velocity in horizontal saccades

    Saccade velocity in degrees per seconds (˚/s) during horizontal paradigms. The participant sits in front of a computer screen displaying a moving symbol, which they must follow without moving their head. Eye movements are recorded and analyzed using an eye-tracking device.

    Measured: 1 year

  12. Velocity in vertical saccades

    Saccade velocity in degrees per seconds (˚/s) during vertical paradigms. The participant sits in front of a computer screen displaying a moving symbol, which they must follow without moving their head. Eye movements are recorded and analyzed using an eye-tracking device.

    Measured: 1 year

  13. Horizontal smooth pursuit gain

    The gain refers to the accuracy with which the eyes match the velocity of a moving target. It is a measure of how well the eye movement system keeps up with the speed of the moving object in the horizontal plane. Specifically, gain is calculated as the ratio of eye movement velocity to target velocity. The participant sits in front of a computer screen displaying a moving symbol, which they must follow without moving their head. Eye movements are recorded and analyzed using an eye-tracking device.

    Measured: 1 year

  14. Vertical smooth pursuit gain

    The gain refers to the accuracy with which the eyes match the velocity of a moving target. It is a measure of how well the eye movement system keeps up with the speed of the moving object in the vertical plane. Specifically, gain is calculated as the ratio of eye movement velocity to target velocity. The participant sits in front of a computer screen displaying a moving symbol, which they must follow without moving their head. Eye movements are recorded and analyzed using an eye-tracking device.

    Measured: 1 year

  15. Pupillometry - Amplitude

    Pupillometry is the measurement and analysis of pupil size and its response to light stimuli. The amplitude i.e maximum constriction is the difference between the baseline pupil size and the smallest pupil size achieved after exposure to the light stimulus. The amplitude is measured in millimeters (mm).

    Measured: 1 year

  16. Pupillometry - Velocity

    Pupillometry is the measurement and analysis of pupil size and its response to light stimuli. The velocity is the speed at which the pupil constricts or dilates in response to changes in light intensity. Typically reported in millimeters per second (mm/s).

    Measured: 1 year

Timeline

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

  1. First posted25 Jun 2024
  2. Study start30 Jun 2024 (estimated)
  3. Primary completion30 Oct 2024 (estimated)
  4. Study completion30 Sep 2025 (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
Single blind
Who is masked
Investigator
Enrolment
209 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06473883
Sponsor's protocol ID
20240126
Status last verified
Jun 2024
First submitted
3 Jun 2024
Last updated
25 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Aderman MJ, Meister MR, Roach MH, Dengler BA, Ross JD, Malvasi SR, Cameron KL. Normative Values for Pupillary Light Reflex Metrics Among Healthy Service Academy Cadets. Mil Med. 2024 Jul 3;189(7-8):1593-1602. doi: 10.1093/milmed/usad271.

    PubMed 37522744
  • Brunner R, Bizzini M, Niedermann K, Maffiuletti NA. Epidemiology of Traumatic and Overuse Injuries in Swiss Professional Male Ice Hockey Players. Orthop J Sports Med. 2020 Oct 19;8(10):2325967120964720. doi: 10.1177/2325967120964720. eCollection 2020 Oct.

    PubMed 33178879
  • Chou TY, Huang YL, Leung W, Brown CN, Kaminski TW, Norcross MF. Does prior concussion lead to biomechanical alterations associated with lateral ankle sprain and anterior cruciate ligament injury? A systematic review and meta-analysis. Br J Sports Med. 2023 Dec;57(23):1509-1515. doi: 10.1136/bjsports-2023-106980. Epub 2023 Aug 30.

    PubMed 37648411
  • Clark JF, Ellis JK, Bench J, Khoury J, Graman P. High-performance vision training improves batting statistics for University of Cincinnati baseball players. PLoS One. 2012;7(1):e29109. doi: 10.1371/journal.pone.0029109. Epub 2012 Jan 19.

    PubMed 22276103
  • Clarsen B, Myklebust G, Bahr R. Development and validation of a new method for the registration of overuse injuries in sports injury epidemiology: the Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire. Br J Sports Med. 2013 May;47(8):495-502. doi: 10.1136/bjsports-2012-091524. Epub 2012 Oct 4.

    PubMed 23038786
  • Collins MW, Kontos AP, Reynolds E, Murawski CD, Fu FH. A comprehensive, targeted approach to the clinical care of athletes following sport-related concussion. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):235-46. doi: 10.1007/s00167-013-2791-6. Epub 2013 Dec 12.

    PubMed 24337463
  • Covassin T, Elbin RJ. The female athlete: the role of gender in the assessment and management of sport-related concussion. Clin Sports Med. 2011 Jan;30(1):125-31, x. doi: 10.1016/j.csm.2010.08.001.

    PubMed 21074087
  • Covassin T, Savage JL, Bretzin AC, Fox ME. Sex differences in sport-related concussion long-term outcomes. Int J Psychophysiol. 2018 Oct;132(Pt A):9-13. doi: 10.1016/j.ijpsycho.2017.09.010. Epub 2017 Sep 18.

    PubMed 28927725
  • Dannenbaum E, Chilingaryan G, Fung J. Visual vertigo analogue scale: an assessment questionnaire for visual vertigo. J Vestib Res. 2011;21(3):153-9. doi: 10.3233/VES-2011-0412.

    PubMed 21558640
  • Domenech MA, Sizer PS, Dedrick GS, McGalliard MK, Brismee JM. The deep neck flexor endurance test: normative data scores in healthy adults. PM R. 2011 Feb;3(2):105-10. doi: 10.1016/j.pmrj.2010.10.023.

    PubMed 21333948
  • Eagle SR, Ferris LM, Mucha A, Sinnott A, Marchetti G, Trbovich A, Port N, Clugston J, Ortega J, Collins MW, Broglio SP, McAllister T, McCrea MA, Pasquina P, Kontos AP, Investigators CC. Minimum detectable change and false positive rates of the vestibular/ocular motor screening (VOMS) tool: an NCAA-DoD care consortium analysis. Brain Inj. 2021 Nov 10;35(12-13):1563-1568. doi: 10.1080/02699052.2021.1973561. Epub 2021 Sep 20.

    PubMed 34543099
  • Echemendia RJ, Brett BL, Broglio S, Davis GA, Giza CC, Guskiewicz KM, Harmon KG, Herring S, Howell DR, Master C, McCrea M, Naidu D, Patricios JS, Putukian M, Walton SR, Schneider KJ, Burma JS, Bruce JM. Sport concussion assessment tool - 6 (SCAT6). Br J Sports Med. 2023 Jun;57(11):622-631. doi: 10.1136/bjsports-2023-107036. No abstract available.

    PubMed 37316203
  • Eliason PH, Galarneau JM, Kolstad AT, Pankow MP, West SW, Bailey S, Miutz L, Black AM, Broglio SP, Davis GA, Hagel BE, Smirl JD, Stokes KA, Takagi M, Tucker R, Webborn N, Zemek R, Hayden A, Schneider KJ, Emery CA. Prevention strategies and modifiable risk factors for sport-related concussions and head impacts: a systematic review and meta-analysis. Br J Sports Med. 2023 Jun;57(12):749-761. doi: 10.1136/bjsports-2022-106656.

    PubMed 37316182
  • Emery CA, Cassidy JD, Klassen TP, Rosychuk RJ, Rowe BH. Effectiveness of a home-based balance-training program in reducing sports-related injuries among healthy adolescents: a cluster randomized controlled trial. CMAJ. 2005 Mar 15;172(6):749-54. doi: 10.1503/cmaj.1040805.

    PubMed 15767608
  • Faude O, Rossler R, Junge A, Aus der Funten K, Chomiak J, Verhagen E, Beaudouin F, Dvorak J, Feddermann-Demont N. Head injuries in children's football-results from two prospective cohort studies in four European countries. Scand J Med Sci Sports. 2017 Dec;27(12):1986-1992. doi: 10.1111/sms.12839. Epub 2017 Feb 3.

    PubMed 28054391

Questions about this trial

What is this clinical trial studying?

A study testing Training recommendation in people with Concussion, Brain and Musculoskeletal Pain, run by BrainCare Medical Group.

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 3 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Nina Feddermann-Demont, PD Dr. med (+41 44 500 41 50, daniel.agostino@braincare.swiss), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of injury frequency (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06473883, which also lists 50 linked publications.

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 25 Jun 2024.

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