Trial Outcomes & Findings for Concussion Prevention in Female Soccer Athletes (NCT NCT03014492)
NCT ID: NCT03014492
Last Updated: 2020-11-04
Results Overview
Determine % changes in brain structure between pre-season and post-season in AD, axial diffusivity; FA, fractional anisotropy; MD, mean diffusivity; RD, radial diffusivity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
6 months
Results posted on
2020-11-04
Participant Flow
Participant milestones
| Measure |
Collar Group
Soccer girls that wore the collar device
Q Collar: Collar designed to mitigate slosh in the brain
|
No Collar Group
soccer girls that did not wear the collar
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
28
|
|
Overall Study
COMPLETED
|
44
|
28
|
|
Overall Study
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 |
Collar Group
n=44 Participants
Soccer girls that wore the collar device
Q Collar: Collar designed to mitigate slosh in the brain
|
No Collar Group
n=28 Participants
soccer girls that did not wear the collar
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
44 Participants
n=44 Participants
|
28 Participants
n=28 Participants
|
72 Participants
n=72 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=44 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=72 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=44 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=72 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=44 Participants
|
28 Participants
n=28 Participants
|
72 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=44 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=72 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
44 participants
n=44 Participants
|
28 participants
n=28 Participants
|
72 participants
n=72 Participants
|
|
Age of participant
|
16.06 years
STANDARD_DEVIATION 1.10 • n=44 Participants
|
15.95 years
STANDARD_DEVIATION 1.04 • n=28 Participants
|
16.0 years
STANDARD_DEVIATION 1.07 • n=72 Participants
|
PRIMARY outcome
Timeframe: 6 monthsDetermine % changes in brain structure between pre-season and post-season in AD, axial diffusivity; FA, fractional anisotropy; MD, mean diffusivity; RD, radial diffusivity.
Outcome measures
| Measure |
Collar Group
n=24 Participants
Soccer girls that wore the collar device
Q Collar: Collar designed to mitigate slosh in the brain
|
No Collar Group
n=22 Participants
soccer girls that did not wear the collar
|
|---|---|---|
|
Pre-season to Post-season DTI Percentage Change
FA
|
-0.17 percentage of change
Standard Deviation 1.99
|
-1.27 percentage of change
Standard Deviation 1.35
|
|
Pre-season to Post-season DTI Percentage Change
MD
|
0.45 percentage of change
Standard Deviation 2.23
|
2.83 percentage of change
Standard Deviation 2.46
|
|
Pre-season to Post-season DTI Percentage Change
AD
|
0.37 percentage of change
Standard Deviation 2.23
|
2.58 percentage of change
Standard Deviation 2.34
|
|
Pre-season to Post-season DTI Percentage Change
RD
|
0.53 percentage of change
Standard Deviation 2.72
|
3.52 percentage of change
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: 6 monthsNumber of participants completing EEG
Outcome measures
| Measure |
Collar Group
n=44 Participants
Soccer girls that wore the collar device
Q Collar: Collar designed to mitigate slosh in the brain
|
No Collar Group
n=28 Participants
soccer girls that did not wear the collar
|
|---|---|---|
|
Number of Participants Completing EEG
|
44 Participants
|
28 Participants
|
Adverse Events
Collar Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Collar Group
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