Trial Outcomes & Findings for Movement Assessment for Concussion Management (NCT NCT02776904)
NCT ID: NCT02776904
Last Updated: 2020-02-26
Results Overview
Verbal memory (total % correct from design memory, total correct from memory score from X's and O's) and visual memory (total number correct/4 during module 3) Scores on verbal memory and visual memory range from 70-99 (high scores are better than low scores). Visual motor speed is comprised correct responses/4 for specific modules and the average counted correctly x3 for a specific module. Scores range from 27-39.8 (high scores are better than low scores)
COMPLETED
NA
327 participants
preseason, postseason, end of the school year, pre-season year 2
2020-02-26
Participant Flow
Participant milestones
| Measure |
Healthy Athletes
Healthy Adolescent school athletes 14-18 years old were recruited from central Arkansas schools to complete assessments of gait, balance and computerized cognitive testing through the ImPACT(Immediate post concussion assessment and cognitive testing) baseline assessment.
|
Concussed Athletes
Adolescent males and females (14-19 years of age) with concussion who visited the concussion clinic at a regional Children's Hospital.
|
|---|---|---|
|
Overall Study
STARTED
|
281
|
46
|
|
Overall Study
Gait Assessment
|
178
|
32
|
|
Overall Study
ImPACT
|
21
|
46
|
|
Overall Study
COMPLETED
|
281
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Movement Assessment for Concussion Management
Baseline characteristics by cohort
| Measure |
Healthy Athletes
n=281 Participants
Healthy Adolescent school athletes 14-18 years old were recruited from central Arkansas schools to complete assessments of gait, balance and computerized cognitive testing through the ImPACT(Immediate post concussion assessment and cognitive testing) baseline assessment.
|
Concussed Athletes
n=46 Participants
Adolescent males and females (14-19 years of age) with concussion who visited the concussion clinic at a regional Children's Hospital.
|
Total
n=327 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
281 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
327 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
165 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
132 participants
n=5 Participants
|
44 participants
n=7 Participants
|
176 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
108 participants
n=5 Participants
|
1 participants
n=7 Participants
|
109 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Two or More Races
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Selected
|
41 participants
n=5 Participants
|
0 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: preseason, postseason, end of the school year, pre-season year 2Population: subset from healthy athlete group
Verbal memory (total % correct from design memory, total correct from memory score from X's and O's) and visual memory (total number correct/4 during module 3) Scores on verbal memory and visual memory range from 70-99 (high scores are better than low scores). Visual motor speed is comprised correct responses/4 for specific modules and the average counted correctly x3 for a specific module. Scores range from 27-39.8 (high scores are better than low scores)
Outcome measures
| Measure |
Healthy Athlete IMPACT Score
n=21 Participants
Immediate Post-concussion Assessment and Cognitive Testing will be administered three times (pre-season, post season and end of year) during the school year and testing will not exceed 1 hour per athlete.
Immediate Post-concussion Assessment and Cognitive Testing
|
|---|---|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
pre season verbal memory
|
86.33 score on Immediate post concussion scale
Standard Error 1.470
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
post season year verbal memory
|
84.0 score on Immediate post concussion scale
Standard Error 2.379
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
end of school verbal memory
|
90.73 score on Immediate post concussion scale
Standard Error 2.095
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
pre-season year 2 verbal memory
|
89.1436 score on Immediate post concussion scale
Standard Error 2.707
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
pre-season visual memory
|
69.8361 score on Immediate post concussion scale
Standard Error 3.54
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
post season visual memory
|
81.2 score on Immediate post concussion scale
Standard Error 2.5824
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
end of the school year visual memory
|
81.4659 score on Immediate post concussion scale
Standard Error 2.98
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
pre-season year 2 visual memory
|
82.2006 score on Immediate post concussion scale
Standard Error 2.26
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
preseason visual motor composite
|
36.371 score on Immediate post concussion scale
Standard Error 2.007
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
post season visual motor
|
36.727 score on Immediate post concussion scale
Standard Error 2.05
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
end of school visual motor
|
38.897 score on Immediate post concussion scale
Standard Error 2.215
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
pre-season year 2 visual motor
|
39.3035 score on Immediate post concussion scale
Standard Error 1.665
|
PRIMARY outcome
Timeframe: preseason, postseason and end of the school year and preseason the following yearPopulation: subset from healthy athlete group Measured on Reaction time composite score (Immediate Post Concussion Assessment)
Reaction time Composite is the average correct reaction time of 3 skills Scores range from 0.5 to 0.7 Lower scores are better.
Outcome measures
| Measure |
Healthy Athlete IMPACT Score
n=21 Participants
Immediate Post-concussion Assessment and Cognitive Testing will be administered three times (pre-season, post season and end of year) during the school year and testing will not exceed 1 hour per athlete.
Immediate Post-concussion Assessment and Cognitive Testing
|
|---|---|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
Preseason
|
0.5797 seconds
Standard Error 0.016
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
Post Season
|
0.5780 seconds
Standard Error 0.01615
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
End of the school year
|
0.5902 seconds
Standard Error 0.0166
|
|
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
Pre-season year 2
|
0.6089 seconds
Standard Error 0.01792
|
PRIMARY outcome
Timeframe: Cross-sectional baselinePopulation: Data are not mutually exclusive. Reported for single task and dual task and divided into male and female groups.
For the purposes of this study, parameters that were captured by the GAITRite® include: gait velocity (cm/s); Subjects walk on pathway during single task and dual task is walking while performing a visual memory task on a tablet
Outcome measures
| Measure |
Healthy Athlete IMPACT Score
n=210 Participants
Immediate Post-concussion Assessment and Cognitive Testing will be administered three times (pre-season, post season and end of year) during the school year and testing will not exceed 1 hour per athlete.
Immediate Post-concussion Assessment and Cognitive Testing
|
|---|---|
|
Spatiotemporal Gait Parameters- Gait Velocity
Single Task Gait Velocity Male
|
1.236 cm/sec
Standard Deviation 0.163
|
|
Spatiotemporal Gait Parameters- Gait Velocity
Single Task Gait Velocity Female
|
1.449 cm/sec
Standard Deviation 0.199
|
|
Spatiotemporal Gait Parameters- Gait Velocity
Dual Task Gait Velocity Male
|
1.030 cm/sec
Standard Deviation 0.185
|
|
Spatiotemporal Gait Parameters- Gait Velocity
Dual Task Gait Velocity Female
|
1.232 cm/sec
Standard Deviation 0.196
|
|
Spatiotemporal Gait Parameters- Gait Velocity
Single Task Gait Velocity Female Concussed
|
1.207 cm/sec
Standard Deviation 0.238
|
|
Spatiotemporal Gait Parameters- Gait Velocity
Dual Task Gait Velocity Female Concussed
|
0.974 cm/sec
Standard Deviation 0.18
|
|
Spatiotemporal Gait Parameters- Gait Velocity
Single Task Gait Velocity Male Concussed
|
1.125 cm/sec
Standard Deviation 0.14
|
|
Spatiotemporal Gait Parameters- Gait Velocity
Dual Task Gait Velocity Male Concussed
|
0.922 cm/sec
Standard Deviation 0.18
|
PRIMARY outcome
Timeframe: cross-sectional baselinePopulation: Data are not mutually exclusive. Reported for single task and dual task and divided into male and female groups and healthy and concussed athletes
For the purposes of this study, parameters that were captured by the GAITRite® include:step length (cm);
Outcome measures
| Measure |
Healthy Athlete IMPACT Score
n=210 Participants
Immediate Post-concussion Assessment and Cognitive Testing will be administered three times (pre-season, post season and end of year) during the school year and testing will not exceed 1 hour per athlete.
Immediate Post-concussion Assessment and Cognitive Testing
|
|---|---|
|
Gait Parameters: Step Length (Cm)
Single task step length males
|
68.031 cm
Standard Deviation 6.779
|
|
Gait Parameters: Step Length (Cm)
Single task step length female
|
65.483 cm
Standard Deviation 6.021
|
|
Gait Parameters: Step Length (Cm)
Dual Task Step Length Male
|
60.073 cm
Standard Deviation 7.858
|
|
Gait Parameters: Step Length (Cm)
Dual Task Step Length Female
|
58.650 cm
Standard Deviation 5.885
|
|
Gait Parameters: Step Length (Cm)
Single Task Step Length Female concussed
|
61.26 cm
Standard Deviation 7.94
|
|
Gait Parameters: Step Length (Cm)
Dual Task Gait step length Female Concussed
|
57.22 cm
Standard Deviation 12.79
|
|
Gait Parameters: Step Length (Cm)
Single Task Step length Male Concussed
|
65.63 cm
Standard Deviation 5.11
|
|
Gait Parameters: Step Length (Cm)
Dual Task Step length Male Concussed
|
57.71 cm
Standard Deviation 6.37
|
PRIMARY outcome
Timeframe: cross-sectional baselinePopulation: Data are not mutually exclusive. Reported for single task and dual task and divided into male and female groups and healthy and concussed athletes.
DLS, defined as the percent of the gait cycle (%GC) when both feet are on the ground measured in healthy males and female athletes and concussed males and female athletes
Outcome measures
| Measure |
Healthy Athlete IMPACT Score
n=210 Participants
Immediate Post-concussion Assessment and Cognitive Testing will be administered three times (pre-season, post season and end of year) during the school year and testing will not exceed 1 hour per athlete.
Immediate Post-concussion Assessment and Cognitive Testing
|
|---|---|
|
Gait Parameters- Percent of DLS
Single task % GC in DLS Male
|
29.077 percentage of GC spent on 2 limbs
Standard Deviation 2.631
|
|
Gait Parameters- Percent of DLS
Single task % GC in DLS Female
|
26.922 percentage of GC spent on 2 limbs
Standard Deviation 2.648
|
|
Gait Parameters- Percent of DLS
Dual task % GC in DLS Male
|
31.92 percentage of GC spent on 2 limbs
Standard Deviation 3.461
|
|
Gait Parameters- Percent of DLS
Dual task % GC in DLS Females
|
29.542 percentage of GC spent on 2 limbs
Standard Deviation 3.085
|
|
Gait Parameters- Percent of DLS
Single Task % GC in DLS Female Concussed
|
28.09 percentage of GC spent on 2 limbs
Standard Deviation 3.66
|
|
Gait Parameters- Percent of DLS
Dual Task % of GC in DLS Female
|
30.45 percentage of GC spent on 2 limbs
Standard Deviation 5.29
|
|
Gait Parameters- Percent of DLS
Single task % of GC in DLS male concussed
|
30.33 percentage of GC spent on 2 limbs
Standard Deviation 2.13
|
|
Gait Parameters- Percent of DLS
Dual Task % GC in DLS Male Concussed
|
32.32 percentage of GC spent on 2 limbs
Standard Deviation 2.66
|
PRIMARY outcome
Timeframe: cross-sectional baselinePopulation: Data are not mutually exclusive. Reported for single task and dual task and divided into male and female groups as well as healthy and concussed athletes.
For the purposes of this study, parameters that were captured by the GAITRite® include: SLS, defined as the %GC weight bearing through a single limb.
Outcome measures
| Measure |
Healthy Athlete IMPACT Score
n=210 Participants
Immediate Post-concussion Assessment and Cognitive Testing will be administered three times (pre-season, post season and end of year) during the school year and testing will not exceed 1 hour per athlete.
Immediate Post-concussion Assessment and Cognitive Testing
|
|---|---|
|
Gait Parameters- % of Gait Cycle in SLS
Single task % GC in SLS Male
|
35.290 percentage of gait cycle spent on 1 limb
Standard Deviation 1.504
|
|
Gait Parameters- % of Gait Cycle in SLS
Single task % GC in SLS Female
|
36.522 percentage of gait cycle spent on 1 limb
Standard Deviation 1.352
|
|
Gait Parameters- % of Gait Cycle in SLS
Dual task % GC in SLS Male
|
34.05 percentage of gait cycle spent on 1 limb
Standard Deviation 1.901
|
|
Gait Parameters- % of Gait Cycle in SLS
Dual task % GC in SLS Females
|
35.112 percentage of gait cycle spent on 1 limb
Standard Deviation 1.549
|
|
Gait Parameters- % of Gait Cycle in SLS
Single Task % GC Female Concussed
|
35.85 percentage of gait cycle spent on 1 limb
Standard Deviation 1.796
|
|
Gait Parameters- % of Gait Cycle in SLS
Dual Task % GC Female Concussed
|
34.407 percentage of gait cycle spent on 1 limb
Standard Deviation 1.974
|
|
Gait Parameters- % of Gait Cycle in SLS
Single task % of GC in SLS male concussed
|
34.62 percentage of gait cycle spent on 1 limb
Standard Deviation 1.03
|
|
Gait Parameters- % of Gait Cycle in SLS
Dual Task % GC in SLS Male Concussed
|
33.58 percentage of gait cycle spent on 1 limb
Standard Deviation 1.26
|
PRIMARY outcome
Timeframe: Cross sectional baselinePopulation: Data are not mutually exclusive. Reported for Y balance test divided into male and female groups. Data for concussed subjects is reported in the acute phase and divided into male and female groups.
subset from healthy athlete group and concussed group Measured on YBT in anterior direction
Outcome measures
| Measure |
Healthy Athlete IMPACT Score
n=212 Participants
Immediate Post-concussion Assessment and Cognitive Testing will be administered three times (pre-season, post season and end of year) during the school year and testing will not exceed 1 hour per athlete.
Immediate Post-concussion Assessment and Cognitive Testing
|
|---|---|
|
Y Balance Assessment- Anterior Reach Direction
Male healthy athletes
|
95.34 Index
Standard Deviation 10.814
|
|
Y Balance Assessment- Anterior Reach Direction
Female healthy athletes
|
94.45 Index
Standard Deviation 14.52
|
|
Y Balance Assessment- Anterior Reach Direction
male acute concussed
|
95.13 Index
Standard Deviation 9.8
|
|
Y Balance Assessment- Anterior Reach Direction
female acute concussed
|
95.14 Index
Standard Deviation 12.48
|
PRIMARY outcome
Timeframe: Cross sectional baselinePopulation: Data are not mutually exclusive. Reported for Y balance test divided into male and female groups and healthy and concussed athletes. Data for concussed subjects is reported in the acute phase and divided into male and female groups.
subset from healthy athlete group and concussed group Measured on YBT in postero-lateral direction.
Outcome measures
| Measure |
Healthy Athlete IMPACT Score
n=212 Participants
Immediate Post-concussion Assessment and Cognitive Testing will be administered three times (pre-season, post season and end of year) during the school year and testing will not exceed 1 hour per athlete.
Immediate Post-concussion Assessment and Cognitive Testing
|
|---|---|
|
Y Balance Assessment- Posterolateral Reach Direction
Male healthy athletes
|
78.08 Index
Standard Deviation 10.697
|
|
Y Balance Assessment- Posterolateral Reach Direction
Female healthy athletes
|
70.138 Index
Standard Deviation 10.120
|
|
Y Balance Assessment- Posterolateral Reach Direction
Male acute concussed
|
74.21 Index
Standard Deviation 10.44
|
|
Y Balance Assessment- Posterolateral Reach Direction
female acute concussed
|
83.89 Index
Standard Deviation 14.14
|
PRIMARY outcome
Timeframe: Cross sectional baselinePopulation: Data are not mutually exclusive. Reported for Y balance test divided into male and female groups and healthy and concussed athletes. Data for concussed subjects is reported in the acute phase and divided into male and female groups.
subset from healthy athlete group and concussed group Measured on YBT in postero-medial direction.
Outcome measures
| Measure |
Healthy Athlete IMPACT Score
n=212 Participants
Immediate Post-concussion Assessment and Cognitive Testing will be administered three times (pre-season, post season and end of year) during the school year and testing will not exceed 1 hour per athlete.
Immediate Post-concussion Assessment and Cognitive Testing
|
|---|---|
|
Y Balance Assessment- Postero-medial Reach Direction
Male healthy athletes
|
69.750 Index
Standard Deviation 12.590
|
|
Y Balance Assessment- Postero-medial Reach Direction
Female healthy athletes
|
65.860 Index
Standard Deviation 8.768
|
|
Y Balance Assessment- Postero-medial Reach Direction
male acute concussed
|
68.80 Index
Standard Deviation 11.13
|
|
Y Balance Assessment- Postero-medial Reach Direction
female acute concussed
|
69.17 Index
Standard Deviation 12.66
|
PRIMARY outcome
Timeframe: cross-sectional baselinePopulation: Subset of healthy athletes. The Concussed athlete data for the PVT (as was the ImPACT concussed data) was used clinically to assess individual auditory reaction time and for clinical decision making by the medical team. The concussed PVT data will not be used as aggregate data.
The PVT is a reliable and valid measurement of simple reaction time to an auditory cue. The outcome measure will be the mean reaction time.
Outcome measures
| Measure |
Healthy Athlete IMPACT Score
n=105 Participants
Immediate Post-concussion Assessment and Cognitive Testing will be administered three times (pre-season, post season and end of year) during the school year and testing will not exceed 1 hour per athlete.
Immediate Post-concussion Assessment and Cognitive Testing
|
|---|---|
|
Psychomotor Vigilance Task (PVT)
|
218.57 ms
Standard Deviation 62.78
|
Adverse Events
Healthy Athletes
Concussed Athletes
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Charlotte Yates
University of Arkansas for Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place