Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05713942 |
| Other study ID # |
006 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
August 31, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Federation Internationale de Football Association |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Diagnosing and determining the severity of a sports-related concussion immediately on- or
off-field is challenging, especially because clinical signs can evolve minutes to hours after
the mechanism of injury. Hence, repeated follow-up and serial assessments of a player are
recommended following such an injury.
Current advice, when a player sustains a confirmed or suspected concussive injury, is to
remove them from play immediately and not return to competition or unrestricted training
until signs and symptoms have been managed as per relevant guidelines. To support this
decision the International football Association Board has introduced a trial allowing an
additional permanent concussion substitution in participating competitions. Follow-up
assessment of concussion incidents is recommended to include the Sport Concussion Assessment
Tool 5th Edition. For further assessment of neurocognitive deficits and to inform return to
play decisions, it is recommended that a computerised assessment is also adopted, such as the
Immediate Post-Concussion Assessment and Cognitive Testing tool.
The aims of this study are:
1. To determine the incidence of head trauma and use of concussion substitutions in
football competitions that are participating in the IFAB's permanent concussion
substitution trial.
2. To evaluate the immediate severity of reported concussion signs and symptoms for
football players with a confirmed or suspected concussion.
3. To evaluate the ability of neurocognitive assessments completed post-incident to inform
the clinical diagnosis of concussion.
Description:
1 INTRODUCTION
Concussions represent a subset of traumatic brain injury (TBI), pragmatically described as a
"traumatically induced transient disturbance of brain function caused by a complex
physiological process". A sports-related concussion (SRC) can result in substantially
different outcomes, ranging from no detectable effects to transient functional impairments or
even life-threatening complications. While the immediate effects of most concussions are
short-lived, typically resolving within days, athletes who continue to play following a
concussive event may increase their risk of developing short-, medium-, and long-term
consequences.
TBI and SRC in football have received increased attention from medical and scientific
communities, sports organisations, legislators, the media, as well as the general population.
Consistency in the identification of concussed footballers and their subsequent management
and rehabilitation has received particular focus. It is apparent that the management of
suspected and confirmed concussive events are prominent and contentious issues in football.
Incidence of SRC varies considerably across studies, which may be largely due to
methodological differences. During 51 FIFA affiliated tournaments and 4 Olympic Games from
1998 to 2012, 3944 injuries were reported by the Team Physicians, of which 577 (15%) affected
the head or neck. Eighty-one injuries (2% of all injuries) were given the diagnosis of
concussion. It is pertinent to more accurately establish the incidence of head trauma and
concussive injuries as allows risk exposure to be better understood.
Diagnosing and determining the severity of a SRC immediately on- or off-field is challenging,
especially because clinical signs can evolve minutes to hours after the mechanism of injury.
Hence, repeated follow-up and serial assessments of a player are recommended following such
an injury. Combined injuries of the central and peripheral nervous systems are frequent,
determining the locus of injury and therefore underlying explanation for symptoms is
difficult and often not possible on- or off-field requiring a more focussed examination.
Thus, the diagnosis and estimation of injury severity on- or off-field is a major challenge
for the personnel performing an assessment. Specific predictors of injury severity, prognosis
and the likely temporal resolution of symptoms are yet to be determined in a football
population. Nevertheless, an immediate, targeted and standardised assessment approach to
support clinical decision-making is of great importance, and despite unanswered research
questions in this specific population, it does help to guide the management approach.
Current advice, when a player sustains a confirmed or suspected concussive injury, is to
remove them from play immediately and not return to competition or unrestricted training
until signs and symptoms have been managed as per relevant guidelines. To support this
decision the International football Association Board has introduced a trial allowing an
additional permanent concussion substitution in participating competitions. Follow-up
assessment of concussion incidents is recommended to include the Sport Concussion Assessment
Tool 5th Edition (SCAT5). The SCAT5 is a standardized tool for use by healthcare
professionals in the evaluation of individuals aged 13 years or older, who are suspected of
having sustained an SRC. It comprises a neuropsychological test battery that assesses
attention, memory and neurological function through 8 different domains. It's particular
utility is in the immediate assessment of the athlete and in the first 3-5 days following the
incident, subsequently it can be used to track symptom resolution. For further assessment of
neurocognitive deficits and to inform return to play decisions, it is recommended that a
computerised assessment is also adopted. The Immediate Post-Concussion Assessment and
Cognitive Testing tool version 4 (ImPACT) is a computer-based neurocognitive test battery
that provides an objective measure of neurocognitive functioning as an assessment aid in the
management of concussed individuals aged 12-80 years. The application of these two assessment
modalities and their ability to inform clinical-decision making regarding concussion
diagnosis in a football population has not been considered before, this includes whether
their utility differs if compared to individual or normative baseline neurocognitive
assessment values.
2 PROJECT OBJECTIVES AND DESIGN 2.1 Hypothesis and primary objective
1. The primary aim is to determine the incidence of head trauma and use of concussion
substitutions in football competitions that are participating in the IFAB's permanent
concussion substitution trial.
2. To evaluate the immediate severity of reported concussion signs and symptoms for
football players with a confirmed or suspected concussion.
3. To evaluate the ability of neurocognitive assessments completed post-incident to inform
the clinical diagnosis of concussion.
Our hypothesis is that there will be a variation in concussion severity with most incidents
resulting in minor symptoms only, but still to a level where these can be detected in the
post-incident assessments compared to baseline values and therefore inform the clinical
diagnosis made.
2.2 Primary and secondary endpoints
1. To compare the concussion symptoms and domain scores post-incident with individual
player baseline values, if available, otherwise normative values will be used.
2. To determine the temporal relationship of concussion signs and symptoms following the
injury incident until full return to play.
3. If players consent, to assess mechanisms of concussion injury through video analysis of
the incidents and compare these features to post-incident assessments.
2.3 Project design
International multi-centre prospective cohort study.
3 PROJECT POPULATION AND STUDY PROCEDURES 3.1 Study background
The International Football Association Board (IFAB) have initiated a trial of implementing
additional permanent concussion substitutions (APCS) for actual or suspected concussions as
of January 2021. This has been facilitated by making amendments to Law 3 in the rules of the
game. With this Law there are 2 protocols (Appendix 1), with National Football Associations
able to adopt one in a competition. The protocols are:
- Protocol A: enables one "concussion substitute" per team and no additional substitute
for the opposing team
- Protocol B: enables two "concussion substitutes" per team and an additional substitute
for the opposing team
All 211 FIFA member associations (National Football Associations) are invited to participate
in this trial. Participation is voluntary. The National Football Associations can participate
with as many competitions as they wish and adopt one of the above protocols per competition.
Competitions refer to different levels of organized leagues, as well as cup tournaments.
Additionally, competitions organized by FIFA, such as the FIFA World Cup, are automatically
participating in the trial.
In agreeing to be a part of the trial, the National Football Associations must also supply
FIFA with feedback information so that the Law change can be accurately reviewed. This
feedback is divided into 3 categories and includes competition information, in-game
information, and medical information. The medical information requirements are outlined in
the Concussion Substitutes Trial Medical Assessment and include baseline neurocognitive
assessments (SCAT5 and ImPACT).
3.2 Project population, inclusion and exclusion criteria
All National Football Associations participating in the IFAB's additional permanent
substitutions trial are requested to provide post incident medical assessment data from
appropriately consented players (explained below) within their competitions according to the
following eligibility criteria
Inclusion criteria Male and female football players from teams in a competition participating
in the concussion substitution trial.
Player assessed by medical personnel proficient in the assessment of concussion symptoms
(medical doctor, physiotherapist, or other healthcare professional appropriately certified).
Exclusion criteria Players less than 18 years of age. Players with a current suspected or
confirmed concussion Any other sustained injury that requires hospital admission
3.2 Recruitment, screening, and informed consent procedure
The IFAB additional permanent substitutions trial is expected to run from January 2021 to
August 2023 with potential for extension. All teams from participating competitions will be
contacted and invited to participate. Contact information is gathered from the respective
competition organisers.
All players who experience a concussion incident during the trial period will receive oral
and written information about the research project. The study information will be translated
and be available in the four official FIFA languages; English, German, Spanish, and French.
Additional translations will be discussed on an individual basis with the respective National
Football Association. The players will have the opportunity to provide consent in two parts:
1. Consent to participate with standard concussion medical assessment data, which is coded
to ensure complete anonymisation
2. Consent to participate with video footage analysis of the concussion incident (which
allows identification of the player), combining this information with post-injury
concussion medical assessments
Players do not have to consent to both parts of the research project. A written informed
consent form will be gathered for each part of the project.
3.3 Study procedures
The study is a prospective cohort study, it will run for the same period as the IFAB
additional permanent substitutions trial. All concussion substitutions occurring during the
trial period are registered online through the FIFA data platform by the respective Team or
National Football Association. The research project is considered to have minimal risk, risk
category A according to art. 7 (HRO). No procedures are required from participants as a
direct result of the research project as they will follow standard guidelines on assessment
according to their individual setting. Participants are therefore not exposed to any
additional health risks from participation in the research and there is only a minimal burden
in registration of assessments.
Players who have experienced a suspected or confirmed concussive injury during a competitive
match will be asked to participate in the research project. There is currently no diagnostic
test or biomarker that determines a diagnosis of SRC2, the presence or absence of this
diagnosis is therefore determined by the medical professional with primary responsibility of
the player's care. Medical professionals are requested to complete the Concussion Substitute
Trials Medical Assessment. Additionally, follow-up concussion assessments using the SCAT5
and/or ImPACT performed by a healthcare professional proficient in the assessment of
concussion symptoms should be performed at specific timepoints following the injury. These
assessments should be uploaded on to the FIFA data platform with the associated baseline
neurocognitive assessments (SCAT5 and ImPACT) if these have been completed.
SCAT5 The SCAT5 is a standardized tool for use by healthcare professionals in the evaluation
of individuals 13 years old or older, who are suspected of having sustained a sports-related
concussion. It comprises a neuropsychological test battery that assesses attention and memory
function through 8 different domains 1) Symptom number, 2) Symptom severity, 3) Orientation,
4) Immediate memory, 5) Concentration, 6) Neurological examination, 7) Balance errors, 8)
Delayed recall.
The time required for assessment using the SCAT5 is minimum 10 min. The only equipment
required for the tester is a watch or timer.
Reliability Reliability of the SCAT5 has been tested in other settings. In 62 professional
ice hockey players the two-week test-retest reliability of the SCAT5 baseline scores varied
from poor to high. There was considerable individual variability and most players have
notable short-term fluctuation on performance even if uninjured. The study calculated
stability coefficients using Spearman's r for the separate SCAT5 domains; Symptom number
r=0.85, p<0.001, Symptom severity r=0.84, p<0.001, Orientation (0-30) r=-0.14, p = 0.283,
Immediate memory r=0.40, p=0.001, Concentration r=0.62, p<0.001, Delayed recall (0-10)
r=0.45, p<0.001, Balance errors r=0.40, p=0.001.
The SCAT5 document is submitted separately.
ImPACT The ImPACT is a computer-based neurocognitive test battery that provides an objective
measure of neurocognitive functioning as an assessment aid in the management of concussion in
individuals ages 12-80 years.
The ImPACT test should be performed in an environment which must be quiet and
distraction-free, with no phones or other devices available. The test person should sit
comfortably at a table or desk with a flat, hard surface. A computer with a keyboard and a
mouse or a trackpad is used for the test with all other programs and browsers tabs closed.
The ImPACT provides 5 composite scores for verbal memory, visual memory, visual motor-speed,
reaction time, and impulse control, as well as a total symptom score. Two-factor scores for
memory and speed are also provided.
The time required to perform the ImPACT assessment is maximum 45 min. The equipment needed is
a computer with keyboard, and mouse/trackpad, and access to the online tool (provided free
for all participants through FIFA).
Reliability A meta-analysis of the reliability of the ImPACT has shown moderate to
substantial test-retest reliability of the IMPACT domains with pooled intraclass correlation
coefficients (ICCs): verbal memory: 0.52 (95%CI 0.44-0.66), visual memory: 0.56 (95%CI
0.48-0.62), visual-motor speed: 0.7 (95%CI 0.72-.0.81), and reaction time: 0.65 (95%CI
0.59-0.71).16 No differences were identified based on average length of the test-retest
interval or between athletes and the general population.
Further information on the ImPACT can be found on https://impacttest.com/ and
https://impactconcussion.com/.
Video analysis Given that incident video footage will enable players to be able identified,
all players will need to provide additional informed consent, prior to uploading this
identifiable information regarding. If there is video footage of the incident available, this
can be uploaded directly on to the data platform. Alternatively, broadcast footage will be
sought for analysis.
A standardized video analysis protocol will be adopted to facilitate consistent reporting of
injury mechanism and related match-specific features. This will incorporate the international
consensus definitions of video signs of concussion.
3.4 Withdrawal and discontinuation
Individual participants can withdraw their data from this study without giving a reason at
any time prior to analysis completion.
Participating competitions can withdraw from the IFAB APCS trial at any time without giving a
reason. In such circumstance, the IFAB must be notified in writing. In case the competition
organisers commit a breach of the signed declaration, the IFAB can withdraw the permission to
participate in the trial. In case of any withdrawal from the trial the collected data prior
to withdrawal will be kept, except if requested otherwise.
4 STATISTICS AND METHODOLOGY 4.1. Statistical analysis plan Concussion assessments Concussion
assessment results will be summarized using descriptive statistics (mean, standard deviation,
median, interquartile range) according to their distribution at the specified timepoints when
they were completed following the injury. The rate of compliance with the aspects of the
assessments will be reported.
Post-concussion incident assessment values are compared to individual baseline assessments
when available and to normative reference values in football players. Baseline data obtained
in this study will be combined with baseline data obtained as part of a connected study
within the same project (BASEC application number 2022-00016), it will be the results of this
study which inform the normative reference values in football players. Comparisons to
baseline assessments will be made for each assessment domain and at each specified
post-incident assessment timepoint. The baseline data will also be used to create cut-off
scores, to assist the diagnostic decision-making process. The appropriateness of adopting the
10th percentile as a cut-off in line with previous research conducted in professional ice
hockey, will be considered.
The data will be assessed for normality and appropriate data transformations or
non-parametric tests will be used if necessary. Depending on distribution dependent-tests and
independent t-tests or Mann-Whitney U test and Wilcoxon Signed Ranks tests will be used for
the group comparisons. Cohen's d will be used to estimate effect sizes, with effects sizes
interpreted as small (d = 0.2), moderate (d = 0.5), and large (d = 0.8).19 The level of
statistical significance will be set at p-value of <0.05. Receiver operating characteristic
(ROC) curves will be calculated to examine the classification accuracy for concussed and
non-concussed players. In addition, dichotomous data (e.g., diagnosis of concussion) will be
analysed using log-binomial regression models. Adjusting for baseline SCAT5 and ImPACT
scores, these models will be used to calculate relative risks and 95% confidence intervals.
Time to event data, including resolution of recorded symptoms and return to play duration
will be analysed using the log-rank test with a Cox Proportional Hazard model used to
calculate hazard ratios, if the assumptions of proportionality are met.
Sample size Due to the nature of the pathology being investigated, sample size is difficult
to predict or guarantee. The aim is to include all available data during the trial period
with a target of 100 players with concussion incidents, which is considered feasible based on
the international multi-centre nature and length of trial period. Based on reported values
from professional ice hockey it can be expected that the smallest differences on the SCAT5
components will be for immediate memory, concentration, and delayed recall. Informed by this
research, a difference in the concentration score of 0.4 between baseline and post-incident
assessment may be expected. With a baseline mean of 3.5, an average standard deviation of
0.9, an alpha value of 0.05, and a power of 0.8, 81 concussion incidents assessments would be
required for analysis.
Video analysis All concussions with video footage and player consent will be included. A
standardised protocol will be adopted to analyse all footage received. Simple descriptive
statistics will be applied to provide an overview of frequencies of the different concussion
injury mechanisms. Video analysis variables will be compared to concussion assessment
findings (e.g. severity of symptoms) and time to event data (e.g. resolution of symptoms,
return to play duration), if possible, to understand if any correlation exists.
4.2. Handling of missing data Every attempt will be made to ensure a complete dataset, with
Medical Staff being contacted if submissions are not complete. Potential missing data will be
excluded from analysis and reported accordingly.
