Trial Outcomes & Findings for Preventing Youth Soccer Injury (NCT NCT04266925)
NCT ID: NCT04266925
Last Updated: 2020-05-20
Results Overview
average number of injury events requiring player to leave the field or be attended by an adult, across all games in study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
baseline through one hour, which is beginning of the game until the end of the game, averaged across games
Results posted on
2020-05-20
Participant Flow
49 youth soccer teams were included this randomized crossover design. All completed both arms.
Participant milestones
| Measure |
3 Referees First
Three referees were present on the field first during these youth soccer matches.
3 referees present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.
|
1 Referee
One referee was present on the field first during these youth soccer matches.
1 referee present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.
|
|---|---|---|
|
1 Referee Game (~1 Hour)
STARTED
|
23
|
26
|
|
1 Referee Game (~1 Hour)
COMPLETED
|
23
|
26
|
|
1 Referee Game (~1 Hour)
NOT COMPLETED
|
0
|
0
|
|
3 Referee Game (~1 Hour)
STARTED
|
23
|
26
|
|
3 Referee Game (~1 Hour)
COMPLETED
|
23
|
26
|
|
3 Referee Game (~1 Hour)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
3 Referees
n=23 Participants
Three referees were present on the field during these youth soccer matches.
3 referees present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.
|
1 Referee
n=26 Participants
One referee was present on the field during these youth soccer matches.
1 referee present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
23 Participants
n=23 Participants
|
26 Participants
n=26 Participants
|
49 Participants
n=49 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=23 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=49 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=23 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=49 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=23 Participants
|
10 Participants
n=26 Participants
|
21 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=23 Participants
|
16 Participants
n=26 Participants
|
28 Participants
n=49 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
23 Participants
n=23 Participants
|
26 Participants
n=26 Participants
|
49 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: baseline through one hour, which is beginning of the game until the end of the game, averaged across gamesPopulation: youth soccer teams
average number of injury events requiring player to leave the field or be attended by an adult, across all games in study
Outcome measures
| Measure |
3 Referees
n=49 Participants
Three referees were present on the field during these youth soccer matches.
3 referees present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.
|
1 Referee
n=49 Participants
One referee was present on the field during these youth soccer matches.
1 referee present: We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.
|
|---|---|---|
|
Average Number of Injuries During Soccer Matches
|
.4 average number of injuries per game
Standard Deviation .7
|
.4 average number of injuries per game
Standard Deviation .7
|
Adverse Events
3 Referees
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1 Referee
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place