Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in sleep patterns as measured by OURA ring |
Oura Ring is a connected health device worn on the finger that measures sleep. Sleep summaries per day will be compared. |
Daily from baseline until the physician clears the subject for return to play, an average of 7-10 days |
|
| Primary |
Change in depressive state as measured by BDI |
Beck Depression Inventory (BDI) - Self-assessment questionnaire to evaluate depressive state. Made of 21 questions, subjects can be classified from "normal" to extremely depressed |
At baseline, 3 times per week until return to play, and after the physician clears the subject for return to play, an average of 7-10 days |
|
| Primary |
Change in symptoms of Post-Concussion Syndrome as measured by SCAT5 |
Sport Concussion Assessment Tool 5th edition (SCAT5) - Administered questionnaire consisting of 22 questions describing symptoms the subject may be experiencing, also includes intensity of symptoms. Latter portion includes cognitive evaluations. |
At baseline and after the physician clears the subject for return to play, an average of 7-10 days |
|
| Primary |
Change in symptoms of Post-Concussion Syndrome as measured by Rivermead |
Rivermead Post-Concussion Symptom Inventory (Rivermead) - Administered self-assessment questionnaire (16 questions) used to evaluate severity of physical symptoms associated with TBIs that subjects have experience in the last 24-hours. |
At baseline, daily until return to play, and after the physician clears the subject for return to play, an average of 7-10 days |
|
| Primary |
Change in stability and balance as measured by BESS |
Balancing Error Scoring System (BESS) - Objective test to assess static postural stability and balance. Subjects close eyes and perform a single, double, and tandem leg stance for 20 seconds each. Errors in stance are evaluated and tallied, then compared to standard values, more than 10 errors result in failure |
At baseline and after the physician clears the subject for return to play, an average of 7-10 days |
|
| Primary |
Change in cognitive effort as measured by Dot Counting |
Dot Counting - Concentration-type task that allows researchers to measure cognitive effort. Lack of effort may be intentional or unintentional and is used to diagnose a multitude of issues such as schizophrenia and dementia |
At baseline and after the physician clears the subject for return to play, an average of 7-10 days |
|
| Primary |
Change in anxiety levels as measured by BAI |
BECK ANXIETY INVENTORY (BAI): Self-assessment questionnaire to evaluate anxiety levels. Made of 21 questions, subjects can be classified from low to "potentially worrying" levels of anxiety |
At baseline, 3 times per week until return to play, and after the physician clears the subject for return to play, an average of 7-10 days |
|
| Primary |
Change in cognitive ability as measured by WAIS-IV |
WECHSLER ADULT INTELLIGENCE SCALE FOURTH EDITION (WAIS-IV): A type of intelligence test that also evaluates cognitive ability and compares it to a "normbased score." Includes 10 sub-tests, each evaluating either working memory, verbal comprehension, processing speed or perceptual reasoning |
At baseline and after the physician clears the subject for return to play, an average of 7-10 days |
|
| Primary |
Change in visuospatial memory as measured by BVMTR |
BRIEF VISUOSPACIAL MEMORY TEST REVISED (BVMTR): A cognitive evaluation that has subjects memorize a card with multiple shapes/symbols in it for 10 seconds, then requires them to draw that card on a piece of paper with the shapes/symbols in the same locations. A delayed recall may be done as well. Subjects are also asked to identify which 12 shapes/symbols were on the card shown to them |
At baseline and after the physician clears the subject for return to play, an average of 7-10 days |
|
| Primary |
Change in auditory processing as measured by PASAT |
PACED AUDITORY SERIAL ADDITION TEST (PASAT): An auditory processing assessment where subjects listen to a pre-recorded voice listing off various numbers in 3 second intervals. The numbers are single digits and must be added to the number said immediately before the new number |
At baseline and after the physician clears the subject for return to play, an average of 7-10 days |
|
| Primary |
Change in front brain systems as measured by DKEFS |
DELIS-KAPLAN EXECUTIVE FUNCTION SYSTEM (DKEFS): A game-like assessment used to evaluate the function of the frontal lobe and front brain systems. Approved for both young children and adults, abstract and creative thinking are primarily assessed |
At baseline and after the physician clears the subject for return to play, an average of 7-10 days |
|
| Primary |
Change in subjective recovery and stress as measured by SRSS |
SUBJECTIVE RECOVERY STRESS STATE (SRSS): An 8 question validated assessment of subjective recovery and stress, containing 4 dimensions in recovery and 4 dimensions in stress |
Daily from baseline until the physician clears the subject for return to play, an average of 7-10 days |
|
| Primary |
Change in state and trait anxiety as measured by Spielberger STAI |
SPIELBERGER STATE TRAIT ANXIETY INVENTORY: Commonly used measure of state and trait anxiety, and done with 20 very brief questions. This measure will be used only for the Float treatment condition, and done before and after each float session allowing the quantification of Float therapy effects on anxiety, which has been widely published in the Float therapy literature |
3 times per week until the physician clears the subject for return to play, an average of 7-10 days |
|
| Primary |
Change in brain function as measured by Dynavision |
DYNAVISION: The Dynavision is a programmable light board that can be used to assess reaction time, vision processing speed, eye hand coordination, visual field, and ocular motor performance, and has been used previously for concussion assessment and mitigation |
3 times per week until the physician clears the subject for return to play, an average of 7-10 days |
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