Trial · NCT06208813
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Days to asymptomatic | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Days to asymptomatic |
| Secondary | Symptom evaluation - Sport Concussion Office Assessment Tool 6 | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | 22 item symptom list rated on a scale of 0-6 (0=none, 6=severe). |
| Secondary | Standardized Assessment of Concussion - Sport Concussion Office Assessment Tool 6 | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Mental status assessment scored out of 45. |
| Secondary | Orthostatic Vital Signs - Sport Concussion Office Assessment Tool 6 | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Blood pressure (mmHG) measured standing and supine; dichotomized as abnormal or normal considering both assessments for a single score. |
| Secondary | Orthostatic Vital Signs - Sport Concussion Office Assessment Tool 6 | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Heart rate (BPM) measured standing and supine; dichotomized as abnormal or normal considering both assessments for a single score. |
| Secondary | Balance Error Scoring System - Sport Concussion Office Assessment Tool 6 | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Six stances completed on firm and foam surface (double leg, tandem, single leg stances). Errors counted including lifting hands off hips, opening eyes, 30 degrees of hip abduction, putting foot down in single leg stance, and/or remaining out of position for great than 5 seconds. |
| Secondary | Timed Tandem Gait - Sport Concussion Office Assessment Tool 6 | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Walking 3-metre-long line on firm surface heel-to-toe. Three trials completed measured in seconds, and average of trials used as measurement. |
| Secondary | Complex Tandem Gait - Sport Concussion Office Assessment Tool 6 | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Participants instructed to "walk heel-to-toe quickly five steps forward, then continue forward with eyes closed for five steps." Points are counted for each step off the line, 1 point for truncal sway or holding onto an object for support. Completed again backwards. Total points are included for a single score (forward plus backward points). |
| Secondary | Dual Task Gait Cognitive Accuracy Score - Sport Concussion Office Assessment Tool 6 | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Patients are instructed "Now, while you are walking heel-to-toe, I will ask you to recite the following words in reverse order/count backwards out loud by 7's/ recite the months of the year in reverse order." We will measure the cognitive accuracy score (number correct/number attempted). |
| Secondary | Dual Task Gait Average Time - Sport Concussion Office Assessment Tool 6 | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Patients are instructed "Now, while you are walking heel-to-toe, I will ask you to recite the following words in reverse order/count backwards out loud by 7's/ recite the months of the year in reverse order." We will measure the average time (seconds). |
| Secondary | Vestibular/Ocular-Motor Screening Smooth Pursuits | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Test the ability to follow a slowly moving target. The patient and the examiner are seated. The examiner holds a fingertip at a distance of 3 ft. from the patient. The patient is instructed to maintain focus on the target as the examiner moves the target smoothly in the horizontal direction 1.5 ft. to the right and 1.5 ft. to the left of midline. One repetition is complete when the target moves back and forth to the starting position, and 2 repetitions are performed. The target should be moved at a rate requiring approximately 2 seconds to go fully from left to right and 2 seconds to go fully from right to left. The test is repeated with the examiner moving the target smoothly and slowly in the vertical direction 1.5 ft. above and 1.5 ft. below midline for 2 complete repetitions up and down. Again, the target should be moved at a rate requiring approximately 2 seconds to move the eyes fully upward and 2 seconds to move fully downward. Symptoms measured on a scale of 0-6. |
| Secondary | Vestibular/Ocular-Motor Screening Saccades Horizontal | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | The examiner holds two single points (fingertips) horizontally at a distance of 3 ft. from the patient, and 1.5 ft. to the right and 1.5 ft. to the left of midline so that the patient must gaze 30 degrees to left and 30 degrees to the right. Instruct the patient to move their eyes as quickly as possible from point to point. One repetition is complete when the eyes move back and forth to the starting position, and 10 repetitions are performed. Record: Headache, Dizziness, Nausea \& Fogginess ratings after the test. Symptoms measured on a scale of 0-6. |
| Secondary | Vestibular/Ocular-Motor Screening Saccades Vertical | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Repeat the test with 2 points held vertically at a distance of 3 ft. from the patient, and 1.5 feet above and 1.5 feet below midline so that the patient must gaze 30 degrees upward and 30 degrees downward. Instruct the patient to move their eyes as quickly as possible from point to point. One repetition is complete when the eyes move up and down to the starting position, and 10 repetitions are performed. Record: Headache, Dizziness, Nausea \& Fogginess ratings after the test. Symptoms measured on a scale of 0-6. |
| Secondary | Vestibular/Ocular-Motor Screening Convergence | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Measure the ability to view a near target without double vision. The patient is seated and wearing corrective lenses (if needed). The examiner is seated front of the patient and observes their eye movement during this test. The patient focuses on a small target (approximately 14 point font size) at arm's length and slowly brings it toward the tip of their nose. The patient is instructed to stop moving the target when they see two distinct images or when the examiner observes an outward deviation of one eye. Blurring of the image is ignored. The distance in cm. between target and the tip of nose is measured and recorded. Abnormal: Near Point of convergence ≥ 6 cm from the tip of the nose. |
| Secondary | Vestibular/Ocular-Motor Screening Vestibular-Ocular Reflex Horizontal | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | The patient is asked to rotate their head horizontally while maintaining focus on the target. The head is moved at an amplitude of 20 degrees to each side and a metronome is used to ensure the speed of rotation is maintained at 180 beats/minute (one beat in each direction). One repetition is complete when the head moves back and forth to the starting position, and 10 repetitions are performed. Record: Headache, Dizziness, Nausea and Fogginess ratings 10 sec after the test is completed. Symptoms measured on a scale of 0-6. |
| Secondary | Vestibular/Ocular-Motor Screening Vestibular-Ocular Reflex Vertical | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | The test is repeated with the patient moving their head vertically. The head is moved in an amplitude of 20 degrees up and 20 degrees down and a metronome is used to ensure the speed of movement is maintained at 180 beats/minute (one beat in each direction). One repetition is complete when the head moves up and down to the starting position, and 10 repetitions are performed. Record: Headache, Dizziness, Nausea and Fogginess ratings after the test. Symptoms measured on a scale of 0-6. |
| Secondary | Vestibular/Ocular-Motor Screening Visual Motion Sensitivity Test | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Test visual motion sensitivity and the ability to inhibit vestibular-induced eye movements using vision. The patient stands with feet shoulder width apart, facing a busy area of the clinic. The examiner stands next to and slightly behind the patient, so that the patient is guarded but the movement can be performed freely. The patient holds arm outstretched and focuses on their thumb. Maintaining focus on their thumb, the patient rotates, together as a unit, their head, eyes and trunk at an amplitude of 80 degrees to the right and 80 degrees to the left. A metronome is used to ensure the speed of rotation is maintained at 50 beats/min (one beat in each direction). One repetition is complete when the trunk rotates back and forth to the starting position, and 5 repetitions are performed. Record: Headache, Dizziness, Nausea \& Fogginess ratings after the test. Symptoms measured on a scale of 0-6. |
| Secondary | Anxiety Screen - Sport Concussion Office Assessment Tool 6 | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Participants are asked to rate seven items on a 0-3 point Likert-scale (0=Not at all, 3=Nearly every day). Scores are totaled and categorized into 0-4=minimal anxiety, 5-9=mild anxiety, 10-14=moderate anxiety, 15-21=severe anxiety. |
| Secondary | Depression Screen - Sport Concussion Office Assessment Tool 6 | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Participants are asked to rate two items with a variety of item responses. Scores are totaled with a cutpoint being 3 for depression. |
| Secondary | Sleep Screen - Sport Concussion Office Assessment Tool 6 | From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks | Participants are asked to rate five items on a 0-3 point Likert-scale (0=Not at all, 3=Nearly every day). Item responses are total then categorized with 0-4=normal, 5-7 mild, 8-10 moderate, 11-17 severe clinical sleep disorder. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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