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.
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.
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).
- Conditions
- Concussion, Brain, Musculoskeletal Pain
- 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 group | Role | What they receive |
|---|---|---|
| Training recommendation | Experimental | The intervention group will receive training recommendations to prevent concussions and other injuries and improve their performance. Receives: Other: Training recommendation |
| Normal training | No intervention | The 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.
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)
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
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
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
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
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
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:
- Double leg stance with eyes closed, head rotating side to side to a metronome at 120 bpm.
- 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
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
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
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
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
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
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
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
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
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
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.
- First posted25 Jun 2024
- Study start30 Jun 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 209 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrainCare Medical Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Feddermann-Demont, PD Dr.med, Study director, Medical Director
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 37522744Brunner 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 33178879Chou 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 37648411Clark 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 22276103Clarsen 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 23038786Collins 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 24337463Covassin 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 21074087Covassin 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 28927725Dannenbaum 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 21558640Domenech 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 21333948Eagle 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 34543099Echemendia 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 37316203Eliason 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 37316182Emery 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 15767608Faude 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vestibulo-oculomotor and Neuromuscular Training on the Incidence of Concussions and Musculoskeletal Injuries in Competitive Female Football Players
- ClinicalTrials.gov ID
- NCT06473883
- Acronym / sponsor ID
- 20240126
- Conditions
- Concussion, Brain, Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- BrainCare Medical GroupUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Jun 2024 (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 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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training recommendation | Experimental | Other: Training recommendationThe intervention group will receive training recommendations to prevent concussions and other injuries and improve their performance. |
| Normal training | No intervention | –The control group will continue with their regular training without any recommendations for the prevention of head injuries. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Training recommendationThe 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. | Other | Training recommendation |
Primary outcome
Incidence of injury frequency
Time frame: 1 year
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.
16 secondary outcomes
Clinical cervical spine/jaw exam:
Time frame: 1 year
Video-Head Impulse Test (vHIT)
Time frame: 1 year
Dynamic Visual Acuity (DVA)
Time frame: 1 year
Vestibulo/Oculomotor Screening (VOMS)
Time frame: 1 year
Modified Balance Error Scoring System-Test (BESS)
Time frame: 1 year
Dual Task - Concussion Balance Test (COBALT)
Time frame: 1 year
Postural Control - Sway path length
Time frame: 1 year
Postural Control - sway path velocity
Time frame: 1 year
Latency in horizontal saccades
Time frame: 1 year
Latency in vertical saccades
Time frame: 1 year
Velocity in horizontal saccades
Time frame: 1 year
Velocity in vertical saccades
Time frame: 1 year
Horizontal smooth pursuit gain
Time frame: 1 year
Vertical smooth pursuit gain
Time frame: 1 year
Pupillometry - Amplitude
Time frame: 1 year
Pupillometry - Velocity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Background: PubMed 37522744Aderman 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.
- Background: PubMed 33178879Brunner 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.
- Background: PubMed 37648411Chou 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.
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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. This study is not recruiting at the moment.
Nina Feddermann-Demont, PD Dr.med study director
Medical Director
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.