| Primary | Dizziness Handicap Inventory (DHI) | Self-rated questionnaire for dizziness impairment rated on a 3-point scale (0: no; 2: sometimes; 4: always) with a maximum score of 100. Higher scores indicate worse outcome. | | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Earlier Physical Therapy (PT) Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. Two sub-arms include "Vestibular Rehabilitation" n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40 The group allocated to vestibular rehabilitation with home monitoring will perform the vestibular home exercises while wearing one wireless sensor on the head and one on the sternum. When the participant brings the sensors into the physical therapy session each week, the physical therapist will examine the sensor data and likely make a more informed decision as to whether or not to increase the level of difficulty of the exercises. | | OG001 | Later Physical Therapy (Standard of Care) | Participants will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes. After waiting, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. Two sub-arms include "Vestibular Rehabilitation" n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40 The group allocated to vestibular rehabilitation with home monitoring will perform the vestibular home exercises while wearing one wireless sensor on the head and one on the sternum. When the participant brings the sensors into the physical therapy session each week, the physical therapist will examine the home data and likely make a more informed decision as to whether or not to increase the level of difficulty of the exercises. | | OG002 | Physical Therapy With Home Monitoring | Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session. | | OG003 | Physical Therapy (Without Home Monitoring) | Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided. |
| | Units | Counts |
|---|
| Participants | - OG00082
- OG001121
- OG00293
- OG003
|
| | Title | Denominators | Categories |
|---|
| Estimated Mean at Enrollment | | | Title | Measurements |
|---|
| - OG00029.2(25.4 to 33.0)
- OG00134.9(31.4 to 38.4)
- OG00233.3(29.5 to 37.1)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | | 0.013 | a priori threshold p < 0.05 | Slope | -0.097 | | | 2-Sided | 95 | -0.173 | -0.020 | | | The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis). | | Other | Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference. |
|
| Secondary | Neurobehavioral Symptom Inventory (NSI) | Self-rated questionnaire (~5 minutes) for symptom severity on a scale from 0 (none) to 4 (very severe) with a maximum score of 88. High scores indicate worse outcomes. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. | | OG001 | Later Physical Therapy (Standard of Care) | Participants will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes. After waiting, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
|
| Secondary | Quality of Life After Brain Injury (QOLIBRI) | Self-rated questionnaire for quality of life questioning satisfaction on a scale from 0 (not at all) to 4 (very). Scores are transformed to a scale of 0 to 100. Lower scores indicate worse outcomes. | | Posted | | Mean | 95% Confidence Interval | Percent | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. | | OG001 | Later Physical Therapy (Standard of Care) | Participants will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes. After waiting, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
|
| Secondary | Patient Global Impression of Change (PGIC) | This single questionnaire will ask the participant to rate how they perceive their health has changed over the course of treatment. Scores range from 1 to 7 with lower scores indicating worse performance. | | Posted | | Median | Inter-Quartile Range | score on a scale | | Earlier PT Group: Post PT (week 7) / Later PT Group: Post PT (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. Two sub-arms include "Vestibular Rehabilitation" n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40 The group allocated to vestibular rehabilitation with home monitoring will perform the vestibular home exercises while wearing one wireless sensor on the head and one on the sternum. When the participant brings the sensors into the physical therapy session each week, the physical therapist will examine the sensor data and likely make a more informed decision as to whether or not to increase the level of difficulty of the exercises. |
|
| Secondary | Return to Activity Question | One question asking participants how recovered they feel on a 0 (not at all recovered) to 100% (fully recovered and returned to pre-injury level) scale. Lower scores indicate worse outcomes. | | Posted | | Mean | 95% Confidence Interval | Percent (%) | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. | | OG001 | Later Physical Therapy (Standard of Care) | Participants will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes. After waiting, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
|
| Secondary | Dynamic Visual Acuity (DVA) | Physical assessment that assesses gaze stability during head rotations (horizontal and vertical) relative to head-stationary visual acuity. Higher scores indicate worse outcome. | | Posted | | Least Squares Mean | 95% Confidence Interval | lines lost from static visual acuity | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. Two sub-arms include "Vestibular Rehabilitation" n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40 The group allocated to vestibular rehabilitation with home monitoring will perform the vestibular home exercises while wearing one wireless sensor on the head and one on the sternum. When the participant brings the sensors into the physical therapy session each week, the physical therapist will examine the sensor data and likely make a more informed decision as to whether or not to increase the level of difficulty of the exercises. |
|
| Secondary | Vestibular/Ocular-Motor Screening (VOMS) Tool | Physical assessment (~10 minutes) to assess the function of the vestibular- and ocular-motor system, and clinically reporting symptoms of headache, dizziness, nausea, and fogginess during each visual task on a 10-point scale (0: no symptoms; 10 severe symptoms). The total symptom provocation change scores range from 0 to 280. High scores indicate worse outcomes. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. | | OG001 | Later Physical Therapy (Standard of Care) | Participants will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes. After waiting, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
|
| Secondary | Mini-Balance Evaluation Systems Test (Mini-BESTest) | Physical assessment (~20 minutes) to quantify balance and clinically scored on a 3-point scale (0: severe; 2: normal) with a maximum score of 28. Lower scores indicate worse outcomes. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. | | OG001 | Later Physical Therapy (Standard of Care) | Participants will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes. After waiting, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
|
| Secondary | Modified Balance Error Scoring System (mBESS) | Physical assessment (~5 min) that is clinically scored on a scale from 0-10 (0: no errors; 10: 10 or more errors) for each of the three conditions. High scores indicate worse outcomes. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. | | OG001 | Later Physical Therapy (Standard of Care) | Participants will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes. After waiting, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
|
| Secondary | Automated Neuropsychological Assessment Metrics (ANAM) | 20-minute Computer-based test of cognition. Composite scores range from -4 to +4. Lower scores indicate worse outcome. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. | | OG001 | Later Physical Therapy (Standard of Care) | Participants will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes. After waiting, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
|
| Secondary | Instrumented Sway | Participants stand with feet together with eyes closed on a firm (EcFi) and Foam (EcFo) surface for 30 seconds. An inertial sensor around the waist measures the sway area. Larger areas indicate worse performance.We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed. | Two participants fell during EcFo test making the sway area invalid. | Posted | | Mean | 95% Confidence Interval | m^4/s^2 | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. Two sub-arms include "Vestibular Rehabilitation" n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40 The group allocated to vestibular rehabilitation with home monitoring will perform the vestibular home exercises while wearing one wireless sensor on the head and one on the sternum. When the participant brings the sensors into the physical therapy session each week, the physical therapist will examine the sensor data and likely make a more informed decision as to whether or not to increase the level of difficulty of the exercises. |
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| Secondary | Complex Navigation Task | Physical assessment using wearable inertial sensors to quantify the average time to navigate a lap of a complex course (total 8 laps). Participants walk at a self-selected pace around the course under single-task and dual-task auditory Stroop conditions. Longer lap times indicate worse outcomes. | | Posted | | Mean | 95% Confidence Interval | Seconds | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. | | OG001 | Later Physical Therapy (Standard of Care) | Participants will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes. After waiting, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
|
| Secondary | Instrumented Walking: Gait Speed | Physical assessment using wearable inertial sensors to quantify gait kinematics when walking at a self-selected pace in a straight line (9m) with and without the auditory Stroop. Gait speed at enrollment (m/s). Slower gait speeds and slower turning velocity indicate worse outcomes. | 1 Participant from the Later PT group was excluded from Single Task 180 Deg Turn Velocity because of not following directions correctly. | Posted | | Mean | 95% Confidence Interval | m/s | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. Two sub-arms include "Vestibular Rehabilitation" n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40 The group allocated to vestibular rehabilitation with home monitoring will perform the vestibular home exercises while wearing one wireless sensor on the head and one on the sternum. When the participant brings the sensors into the physical therapy session each week, the physical therapist will examine the sensor data and likely make a more informed decision as to whether or not to increase the level of difficulty of the exercises. |
|
| Secondary | Instrumented Walking: 180 Degree Turn Velocity | Physical assessment using wearable inertial sensors to quantify gait kinematics when walking at a self-selected pace in a straight line (9m) with and without the auditory Stroop. Measure: 180-degree turning speed. Slower turning velocities indicate worse outcomes. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed. | 1 Participant from the Later PT group was excluded from Single Task 180 Deg Turn Velocity because of not following directions correctly. | Posted | | Mean | 95% Confidence Interval | degrees per second | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. Two sub-arms include "Vestibular Rehabilitation" n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40 The group allocated to vestibular rehabilitation with home monitoring will perform the vestibular home exercises while wearing one wireless sensor on the head and one on the sternum. When the participant brings the sensors into the physical therapy session each week, the physical therapist will examine the sensor data and likely make a more informed decision as to whether or not to increase the level of difficulty of the exercises. |
|
| Secondary | Instrumented Walking: Percentage of Double Support of Gait Cycle | Physical assessment using wearable inertial sensors to quantify gait kinematics when walking at a self-selected pace in a straight line (9m) with and without the auditory Stroop. Percentage of gait cycle in double support were the outcome measure. Larger percentages of double support time indicate worse outcomes. | 1 Participant from the Later PT group was excluded from Single Task 180 Deg Turn Velocity because of not following directions correctly. | Posted | | Mean | 95% Confidence Interval | % of Gait Cycle | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. Two sub-arms include "Vestibular Rehabilitation" n=40, and "Vestibular Rehabilitation with Home Monitoring" n=40 The group allocated to vestibular rehabilitation with home monitoring will perform the vestibular home exercises while wearing one wireless sensor on the head and one on the sternum. When the participant brings the sensors into the physical therapy session each week, the physical therapist will examine the sensor data and likely make a more informed decision as to whether or not to increase the level of difficulty of the exercises. |
|
| Secondary | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Physical assessment (~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate sensory weighting. This outcome is unitless for the weights as they are percentage values (0-1). We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed. | Some participants were not able to complete both conditions of the CSMI test. | Posted | | Mean | 95% Confidence Interval | unitless (% of sensory system of balance | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
|
| Secondary | Central Sensorimotor Integration (CSMI) Test: Time Delay | Physical assessment (~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate time delay within the neural controller. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed. | Some participants were not able to complete both conditions of the CSMI test. | Posted | | Mean | 95% Confidence Interval | ms | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
|---|
| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
|
| Secondary | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Physical assessment (~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate normalized stiffness for neural controller. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed. | Some participants were not able to complete both conditions of the CSMI test. | Posted | | Mean | 95% Confidence Interval | unitless (%) | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
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| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
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| Secondary | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Physical assessment (~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate normalized damping for neural controller. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed. | Some participants were not able to complete both conditions of the CSMI test. | Posted | | Mean | 95% Confidence Interval | unitless (%) | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
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| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
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| Secondary | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Physical assessment (~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to calculate evoked center-of-mass (CoM) sway. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed. | Some participants were not able to complete both conditions of the CSMI test. | Posted | | Mean | 95% Confidence Interval | deg | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
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| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
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| Secondary | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Physical assessment (~45 min) to quantify sway response from a pseudo-random rotating visual surround stimulus on a fixed surface with eyes open (VS/EO) or from combined rotating visual surround and stance surface stimuli (SS+VS/EO) to internal sensory noise. We generated inverse probability weights using data from all subjects, thus the overall number of participants (not the number of participants without missing values) as the overall participants analyzed. | Some participants were not able to complete both conditions of the CSMI test. | Posted | | Mean | 95% Confidence Interval | deg | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
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| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. | |
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| Other Pre-specified | Post-concussion Symptom Scale From the Sport Concussion Assessment (SCAT) Tool Version 5 | A weekly questionnaire assessing mTBI symptom severity over 14 weeks with 22 items rated from 0 (none) to 6 (severe). Total symptom severity score out of 132. High scores indicate worse performance. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Collected weekly throughout study duration (week 0 to week 14). | | | | ID | Title | Description |
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| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. | | OG001 | Later Physical Therapy (Standard of Care) | Participants will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes. After waiting, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
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| Other Pre-specified | Insomnia Severity Index (ISI) | Self-rated questionnaire (~5 minutes) to rate sleep as a potential covariate for recovery rated on a 5-point scale (0: none; 4: very severe) with a maximum score of 28. High scores indicate worse outcomes. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
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| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. | | OG001 | Later Physical Therapy (Standard of Care) | Participants will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes. After waiting, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
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| Other Pre-specified | Head Impact Test (HIT) - 6 | Self-rated questionnaire (~5 minutes of 6 items to rate headache severity as a potential covariate for recovery rated on a 5-point scale (6: never; 13: always) with a maximum score of 78. High scores indicate worse outcomes. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Baseline (week 0), Pre (week 7), and Post Physical Therapy (week 14) | | | | ID | Title | Description |
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| OG000 | Earlier Physical Therapy | Within a week of enrollment and baseline testing, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. | | OG001 | Later Physical Therapy (Standard of Care) | Participants will wait 6 weeks after enrollment and baseline testing before starting physical therapy. Before starting physical therapy participants will be re-tested on study outcomes. After waiting, participants will see a physical therapist in person twice per week for 2 weeks and once per week for 4 weeks for a total of 8 sessions over 6 weeks. Each physical therapy session will last 60 minutes and consist of cardiovascular exercise, cervical spine exercises, and vestibular therapy exercises (static and dynamic balance). Participants perform daily home exercises for approximately 30 minutes with similar subcategories from the in-person physical therapy sessions. Both the in-person physical therapy and home exercises will be individualized and progressive in the sense that each exercise can increase the level of difficulty at the discretion of the physical therapist depending on the performance of the participant. |
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