Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05542628 |
| Other study ID # |
2 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Federation Internationale de Football Association |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The primary objective is to provide normal concussion assessment references values for use in
football.
All National Football Associations participating in The International Football Association
Board's additional permanent substitutions trial are requested to provide baseline assessment
data from players within their competitions
Description:
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 deficits 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-term, medium-term, and long-term
consequences.
Diagnosing and determining the severity of a SRC immediately on- or off-field is challenging,
especially because clinical signs can evolve after the mechanism of injury. Since 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. Nevertheless, an immediate, targeted assessment to support clinical
decision-making is of great importance and helps 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. 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 and memory
function through 8 different domains. For further assessment of neurocognitive deficits and
to inform return to play decisions, the Immediate Post-Concussion Assessment and Cognitive
Testing tool version 4 (ImPACT) can also provide valuable information. 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 concussed individuals
aged 12-80 years.
Post-injury assessments can be compared to the player's assessment results from a
non-concussed state (baseline assessment), adding more useful information to their
interpretation. Unfortunately, many players do not have baseline assessments performed.
Therefore, reference values from similar population groups can act as comparator to determine
severity and progression of signs and/or symptoms. Reference values are reported in several
sports, but values specific to football players are lacking.
The primary objective is to provide normal concussion assessment references values for use in
football.
Our hypothesis is that there will be a variation of minor symptoms in non-concussed players.
Secondary objectives are to provide cumulative frequency distribution of the number of
symptoms endorsed at baseline, as well as individual symptom endorsement. Additionally, we
aim to provide an overview of cut-off scores and classification ranges to create a reference
guide for clinicians of broadly normal and uncommon assessments. Where possible serial
baseline assessments will be compared to confirm reliability.
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 if they have (or expect to) performed baseline
assessments within the trial period. Contact information is gathered from the respective
competition organisers.
The study is cross-sectional. There are no added procedures which participants have to
undertake as being part of the study. The neurocognitive baseline assessments performed
should already be a standard component of club practice, in line with international consensus
guidelines. Normal practice is that baseline assessments are performed during the pre-season
preparation period, at the time of contract commencement for a player entering a new club or
one month after having been asymptomatic and medically cleared from a previous concussion
injury. Other baseline demographic data will include playing position, age, sex and
concussion history. The study will run for the same period as the trial. Early analysis of
baseline data can be performed when all competitions have indicated their ability and
willingness to participate in this study.
There is a risk of selection bias with potential higher representation of participants
competitions with greater resources. To account for this, the study will accept data in any
format to reduce the minor burden of participation.
Statistical analysis plan
Demographic data and baseline SCAT5 and ImPACT assessment results are summarized using
descriptive statistics according to distribution to provide normal references values. Normal
values will be calculated for men and women separately, and according to age, and number of
previous concussions. Potential post hoc comparisons between sub-groups will be analysed
using independent t-tests or Mann-Whitney U-test according to distributions, and the level of
statistical significance will be set at p-value of <0.05.
Sample-size calculation is not performed due to the exploratory study design. We aim to
include all available data, but a target of participant data from 1000-2000 players is
expected and considered to provide a relevant impression of normal reference values. Data
will be analyzed separately for specific federations given sufficient representativeness.
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