Balance; Distorted, Gait, Unsteady, Mild Traumatic Brain Injury, Quality of Life, Veterans
Conditions
Keywords
mild traumatic brain injury, vestibular impairment, balance and gait, dual-tasking, veterans, quality of life, rehabilitation
Brief summary
Every year 1.7 million people sustain a traumatic brain injury (TBI) in the United States and of these, 84 % are considered mild TBI (mTBI). mTBI is common both in civilian and military populations and can be debilitating if symptoms do not resolve after injury. Balance problems are one of the most common complaints after sustaining a mTBI and often prevent individuals from returning to their previous quality of life. However, the investigators currently lack clear guidelines on when to initiate physical therapy rehabilitation and it is unclear if early physical therapy is beneficial. The investigators believe that the underlying problem of imbalance results from damage to parts of the brain responsible for interpreting sensory information for balance control. The investigators hypothesize that retraining the brain early, as opposed to months after injury, to correctly interpret sensory information will improve recovery. The investigators also believe this retraining is limited when rehabilitation exercises are performed incorrectly, and that performance feedback from wearable sensors, can improve balance rehabilitation. There are three objectives of this study: 1) to determine how the timing of rehabilitation affects outcomes after mTBI; 2) to determine if home monitoring of balance exercises using wearable sensors improves outcomes; and 3) to develop a novel feedback system using wearable sensors to provide the physical therapist information, in real-time during training, about quality of head and trunk movements during prescribed exercises. The findings from this research could be very readily adopted into military protocols for post-mTBI care and have the potential to produce better balance rehabilitation and quality of life for mTBI patients and their families.
Detailed description
Although balance is one of the most common and debilitating complaints after mTBI, the investigators currently lack clear guidelines on when to initiate balance rehabilitation and it is unclear if early physical therapy is beneficial. There is a clear gap in clinical care guidelines after mTBI and it is unclear if initiating rehabilitation early would improve outcomes related to imbalance. Measures of imbalance are subjective and are easily overlooked as a treatable deficit. Even with rehabilitation, recovery of balance in people with mTBI is challenging, particularly in people with central vestibular and sensory integration deficits. Although vestibular and balance rehabilitation after mTBI relies heavily on a home exercise program and repetition is essential for recovery; The slow progress in balance rehabilitation may be partially due to an inability of people with mTBI to correctly perform the prescribed rehabilitation exercises on their own. Biofeedback is a clinical technique that provides physiologic information that would otherwise be unknown to patients and may improve outcomes after mTBI. There are no commercially available systems to provide the physical therapist and/or patient objective information on the quality of head movements during training of rehabilitation tasks that involve balance and walking. Therefore, the three objectives of this study are: 1) to determine how the timing of rehabilitation affects outcomes after mTBI; 2) to determine if home monitoring of home balance exercises using wearable sensors improves outcomes; and 3) to develop a novel feedback system using wearable sensors to provide the physical therapist information, in real-time during training, about quality of head and trunk movements during prescribed exercises. 160 individuals with subacute mTBI within 2-12 weeks of the injury will be randomly assigned to receive earlier onset of physical therapy (n=80) right away or be randomly assigned to receive later rehabilitation 6 weeks after enrollment in the standard of care physical therapy group (n=80). A subgroup of participants in the earlier physical therapy (n=40) and standard of care physical therapy (n=40) will be randomly assigned to home monitoring. The participants in the home monitoring subgroups will wear wireless sensors while completing the rehabilitation program to better inform the physical therapist of their progress. The outcome measures will consist of a battery of self-reported questionnaires, and balance and gait measures and will be tested at Pre I (baseline), Pre 2 (6 weeks after baseline for the later physical therapy group), Post (after the intervention), and Retention (6 month follow-up). Peripheral vestibular and ocular motor assessments will occur at the baseline visit only. The central hypothesis is that rehabilitation after mTBI is suboptimal due to late initiation of and inadequate performance of exercises that do not adequately challenge vestibular and sensory integration function. The long-term goal is to clarify best practices for the rehabilitation of balance deficits in people with mTBI by comparing earlier vs later (standard of care) initiation of physical therapy with and without wearable sensors on balance deficits after mTBI. The findings from this research could be very readily adopted into military protocols for post-mTBI care and have the potential to produce better balance rehabilitation and quality of life for mTBI patients and their families.
Interventions
BEHAVIORALTiming of Rehabilitation
Participants in the Earlier Physical Therapy group will start physical therapy within a week of enrollment and baseline testing. Participants allocated to the Later Physical Therapy group will wait 6 weeks after enrollment and baseline testing before starting physical therapy, and re-test on study outcomes before starting physical therapy. Both groups 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 session will last 60 minutes and consist of cardiovascular, cervical spine, and vestibular therapy exercises (static and dynamic balance). Participants will perform daily home exercises for 30 minutes with similar subcategories from the in-person sessions. Both the in-person physical therapy and home exercises will be individualized and progressive at the discretion of the physical therapist depending on the performance of the participant.
BEHAVIORALBiofeedback
Wearable sensors measure movement during the home exercise program for later feedback.
Sponsors
United States Department of Defense
Medical Research Foundation, Oregon
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Single-blinded design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Inclusion criteria will consist of being 1) 18-60 years of age; 2) having no more than minimal cognitive impairment as assessed by the Short Blessed test; 3) having a physician-diagnosed mTBI and being within 2-12 weeks of the injury; and 4) endorsing ≥1 on either balance, dizziness, nausea, headache, or vision problems on the symptom evaluation scale from the Sport Concussion Assessment Tool (SCAT 5) and a total symptom severity score ≥15.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dizziness Handicap Inventory (DHI) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Instrumented Sway | 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) | 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. |
| Central Sensorimotor Integration (CSMI) Test: Normalized Damping | 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) | 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. |
| Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | 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) | 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. |
| Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | 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) | 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. |
| Neurobehavioral Symptom Inventory (NSI) | 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) | 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. |
| Quality of Life After Brain Injury (QOLIBRI) | 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) | 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. |
| Patient Global Impression of Change (PGIC) | Earlier PT Group: Post PT (week 7) / Later PT Group: Post PT (week 14) | 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. |
| Return to Activity Question | 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) | 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. |
| Dynamic Visual Acuity (DVA) | Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Pre (week 7), and Post Physical Therapy (week 14) | Physical assessment that assesses gaze stability during head rotations (horizontal and vertical) relative to head-stationary visual acuity. Higher scores indicate worse outcome. |
| Vestibular/Ocular-Motor Screening (VOMS) Tool | 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) | 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. |
| Mini-Balance Evaluation Systems Test (Mini-BESTest) | 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) | 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. |
| Modified Balance Error Scoring System (mBESS) | 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) | 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. |
| Automated Neuropsychological Assessment Metrics (ANAM) | 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) | 20-minute Computer-based test of cognition. Composite scores range from -4 to +4. Lower scores indicate worse outcome. |
| Complex Navigation Task | 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) | 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. |
| Instrumented Walking: Gait Speed | 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) | 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. |
| Instrumented Walking: 180 Degree Turn Velocity | 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) | 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. |
| Instrumented Walking: Percentage of Double Support 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) | 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. |
| Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | 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) | 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. |
| Central Sensorimotor Integration (CSMI) Test: Time Delay | 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) | 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. |
| Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | 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) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Head Impact Test (HIT) - 6 | 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) | 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. |
| Insomnia Severity Index (ISI) | 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) | 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. |
| Post-concussion Symptom Scale From the Sport Concussion Assessment (SCAT) Tool Version 5 | Collected weekly throughout study duration (week 0 to week 14). | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were screened for eligibility (n=2522) and recruited from institutional and local clinics in the Portland Metropolitan area. Recruitment and enrollment started in July 2018 and ended in March of 2023.
Pre-assignment details
In-person physical therapy (PT) stopped March 2020 due to COVID-19. From April 2020 to September 2020, 18 participants were enrolled in the study and received telerehabilitation. However, these participants were not included in further analyses due to differences from the in-person PT sessions. Although there are 4 arms to the study, those included in the early and late PT groups were the same people in the home monitoring groups. Therefore, the total included is 203 (not 406).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 81 |
| 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. | 121 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Early and Late Physical Therapy | Early Termination - PI Decision | 2 | 8 | 0 | 0 |
| Early and Late Physical Therapy | Lost to Follow-up | 2 | 18 | 0 | 0 |
| Early and Late Physical Therapy | Withdrawal by Subject | 15 | 32 | 0 | 0 |
| Home Monitoring | Early Termination - PI Decision | 0 | 0 | 4 | 6 |
| Home Monitoring | Lost to Follow-up | 0 | 0 | 8 | 12 |
| Home Monitoring | Withdrawal by Subject | 0 | 0 | 17 | 30 |
Baseline characteristics
| Characteristic | Earlier Physical Therapy | Later Physical Therapy (Standard of Care) | Total |
|---|---|---|---|
| Age, Continuous | 35.6 years STANDARD_DEVIATION 11.6 | 36.0 years STANDARD_DEVIATION 11.2 | 35.9 years STANDARD_DEVIATION 11.3 |
| Body Mass Index | 25.1 kg/m2 STANDARD_DEVIATION 4.9 | 27.3 kg/m2 STANDARD_DEVIATION 8 | 26.4 kg/m2 STANDARD_DEVIATION 7 |
| Days Since Injury at Enrollment | 45.9 days STANDARD_DEVIATION 20.1 | 45.4 days STANDARD_DEVIATION 22.4 | 45.6 days STANDARD_DEVIATION 21.5 |
| Injury Mechanism bike-related | 3 Participants | 6 Participants | 9 Participants |
| Injury Mechanism fall | 17 Participants | 23 Participants | 40 Participants |
| Injury Mechanism motor vehicle accident | 24 Participants | 47 Participants | 71 Participants |
| Injury Mechanism other | 19 Participants | 28 Participants | 47 Participants |
| Injury Mechanism sport-related | 18 Participants | 17 Participants | 35 Participants |
| mild traumatic brain injury (mTBI) History No | 43 Participants | 57 Participants | 100 Participants |
| mild traumatic brain injury (mTBI) History Yes | 38 Participants | 64 Participants | 102 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 13 Participants | 18 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) White | 65 Participants | 98 Participants | 163 Participants |
| Region of Enrollment United States | 81 participants | 121 participants | 202 participants |
| Sex/Gender, Customized Sex/Gender Female | 63 Participants | 96 Participants | 159 Participants |
| Sex/Gender, Customized Sex/Gender Male | 18 Participants | 20 Participants | 38 Participants |
| Sex/Gender, Customized Sex/Gender Other | 0 Participants | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 121 | 0 / 93 | 0 / 110 |
| other Total, other adverse events | 3 / 82 | 0 / 121 | 2 / 93 | 1 / 110 |
| serious Total, serious adverse events | 0 / 82 | 0 / 121 | 0 / 93 | 0 / 110 |
Outcome results
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.
Time frame: 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)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Dizziness Handicap Inventory (DHI) | Estimated Mean at Enrollment | 29.2 score on a scale |
| Earlier Physical Therapy | Dizziness Handicap Inventory (DHI) | Estimated Change per Day | -0.202 score on a scale |
| Later Physical Therapy (Standard of Care) | Dizziness Handicap Inventory (DHI) | Estimated Change per Day | -0.105 score on a scale |
| Later Physical Therapy (Standard of Care) | Dizziness Handicap Inventory (DHI) | Estimated Mean at Enrollment | 34.9 score on a scale |
| Physical Therapy With Home Monitoring | Dizziness Handicap Inventory (DHI) | Estimated Mean at Enrollment | 33.3 score on a scale |
| Physical Therapy With Home Monitoring | Dizziness Handicap Inventory (DHI) | Estimated Change per Day | -0.133 score on a scale |
| Physical Therapy (Without Home Monitoring) | Dizziness Handicap Inventory (DHI) | Estimated Mean at Enrollment | 32.1 score on a scale |
| Physical Therapy (Without Home Monitoring) | Dizziness Handicap Inventory (DHI) | Estimated Change per Day | -0.102 score on a scale |
p-value: 0.01395% CI: [-0.173, -0.02]Mixed Models Analysis
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Automated Neuropsychological Assessment Metrics (ANAM) | Estimated Mean at Enrollment | -0.730 score on a scale |
| Earlier Physical Therapy | Automated Neuropsychological Assessment Metrics (ANAM) | Estimated Change per Day | 0.00647 score on a scale |
| Later Physical Therapy (Standard of Care) | Automated Neuropsychological Assessment Metrics (ANAM) | Estimated Change per Day | 0.00256 score on a scale |
| Later Physical Therapy (Standard of Care) | Automated Neuropsychological Assessment Metrics (ANAM) | Estimated Mean at Enrollment | -0.732 score on a scale |
| Physical Therapy With Home Monitoring | Automated Neuropsychological Assessment Metrics (ANAM) | Estimated Mean at Enrollment | -0.787 score on a scale |
| Physical Therapy With Home Monitoring | Automated Neuropsychological Assessment Metrics (ANAM) | Estimated Change per Day | 0.0028 score on a scale |
| Physical Therapy (Without Home Monitoring) | Automated Neuropsychological Assessment Metrics (ANAM) | Estimated Mean at Enrollment | -0.685 score on a scale |
| Physical Therapy (Without Home Monitoring) | Automated Neuropsychological Assessment Metrics (ANAM) | Estimated Change per Day | 0.0034 score on a scale |
p-value: 0.08395% CI: [-0.00052, 0.00835]Mixed Models Analysis
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.
Time frame: 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)
Population: Some participants were not able to complete both conditions of the CSMI test.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Evoked CoM Sway (VS/EO) Change per Day | -0.004 deg |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Mean Evoked CoM Sway (VS/EO) at Enrollment | 0.289 deg |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Mean Evoked CoM Sway (SS+VS/EO) at Enrollment | 1.093 deg |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Evoked CoM Sway (SS+VS/EO) Change per Day | -0.001 deg |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Evoked CoM Sway (VS/EO) Change per Day | -0.0004 deg |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Mean Evoked CoM Sway (SS+VS/EO) at Enrollment | 1.068 deg |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Mean Evoked CoM Sway (VS/EO) at Enrollment | 0.281 deg |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Evoked CoM Sway (SS+VS/EO) Change per Day | 0.0002 deg |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Mean Evoked CoM Sway (VS/EO) at Enrollment | 0.308 deg |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Evoked CoM Sway (VS/EO) Change per Day | -0.00029 deg |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Evoked CoM Sway (SS+VS/EO) Change per Day | -0.00036 deg |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Mean Evoked CoM Sway (SS+VS/EO) at Enrollment | 1.116 deg |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Evoked CoM Sway (SS+VS/EO) Change per Day | -0.00049 deg |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Mean Evoked CoM Sway (SS+VS/EO) at Enrollment | 1.050 deg |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Evoked CoM Sway (VS/EO) Change per Day | -0.00014 deg |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway | Estimated Mean Evoked CoM Sway (VS/EO) at Enrollment | 0.265 deg |
Comparison: Analysis for CSMI Outcome - Evoked Center of Mass (CoM) Sway (VS/EO)p-value: 0.00395% CI: [-0.006, -0.001]Mixed Models Analysis
Comparison: Analysis for CSMI Outcome - Evoked CoM Sway (SS+VS/EO)p-value: 0.00495% CI: [-0.003, -0.0005]Mixed Models Analysis
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.
Time frame: 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)
Population: Some participants were not able to complete both conditions of the CSMI test.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Internal Sensory Noise (VS/EO) Change per Day | -0.003 deg |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Internal Sensory Noise (SS+VS/EO) Change per Day | -0.003 deg |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Mean Internal Sensory Noise (VS/EO) at Enrollment | 0.088 deg |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Mean Internal Sensory Noise (SS+VS/EO) at Enrollment | 0.136 deg |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Mean Internal Sensory Noise (VS/EO) at Enrollment | 0.087 deg |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Internal Sensory Noise (SS+VS/EO) Change per Day | -0.0005 deg |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Internal Sensory Noise (VS/EO) Change per Day | 0.0002 deg |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Mean Internal Sensory Noise (SS+VS/EO) at Enrollment | 0.126 deg |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Mean Internal Sensory Noise (VS/EO) at Enrollment | 0.092 deg |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Internal Sensory Noise (SS+VS/EO) Change per Day | 0.0000097 deg |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Mean Internal Sensory Noise (SS+VS/EO) at Enrollment | 0.135 deg |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Internal Sensory Noise (VS/EO) Change per Day | 0.000054 deg |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Internal Sensory Noise (SS+VS/EO) Change per Day | -0.00030 deg |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Internal Sensory Noise (VS/EO) Change per Day | -0.000051 deg |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Mean Internal Sensory Noise (SS+VS/EO) at Enrollment | 0.127 deg |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise | Estimated Mean Internal Sensory Noise (VS/EO) at Enrollment | 0.084 deg |
Comparison: Analysis for CSMI Outcome - Internal Sensory Noise (VS/EO)p-value: 0.03195% CI: [-0.007, -0.0003]Mixed Models Analysis
Comparison: Analysis for CSMI Outcome - Internal Sensory Noise (SS+VS/EO)p-value: 0.00395% CI: [-0.005, -0.0003]Mixed Models Analysis
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.
Time frame: 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)
Population: Some participants were not able to complete both conditions of the CSMI test.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Mean Normalized Damping (VS/EO) at Enrollment | 0.469 unitless (%) |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Normalized Damping (VS/EO) Change per Day | 0.0001 unitless (%) |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Mean Normalized Damping (SS+VS/EO) at Enrollment | 0.491 unitless (%) |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Normalized Damping (SS+VS/EO) Change per Day | 0.0002 unitless (%) |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Normalized Damping (VS/EO) Change per Day | -0.0001 unitless (%) |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Mean Normalized Damping (SS+VS/EO) at Enrollment | 0.496 unitless (%) |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Normalized Damping (SS+VS/EO) Change per Day | -0.0002 unitless (%) |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Mean Normalized Damping (VS/EO) at Enrollment | 0.469 unitless (%) |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Mean Normalized Damping (SS+VS/EO) at Enrollment | 0.485 unitless (%) |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Normalized Damping (VS/EO) Change per Day | 0.000050 unitless (%) |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Normalized Damping (SS+VS/EO) Change per Day | 0.000015 unitless (%) |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Mean Normalized Damping (VS/EO) at Enrollment | 0.456 unitless (%) |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Normalized Damping (SS+VS/EO) Change per Day | -0.000011 unitless (%) |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Normalized Damping (VS/EO) Change per Day | -0.00009 unitless (%) |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Mean Normalized Damping (VS/EO) at Enrollment | 0.479 unitless (%) |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Normalized Damping | Estimated Mean Normalized Damping (SS+VS/EO) at Enrollment | 0.501 unitless (%) |
Comparison: Analysis for CSMI Outcome - Normalized Damping (VS/EO)p-value: 0.24795% CI: [-0.0001, 0.0004]Mixed Models Analysis
Comparison: Analysis for CSMI Outcome - Normalized Damping (SS+VSEO)p-value: 0.00895% CI: [0.0001, 0.0007]Mixed Models Analysis
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.
Time frame: 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)
Population: Some participants were not able to complete both conditions of the CSMI test.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Mean Normalized Stiffness (VS/EO) at Enrollment | 1.219 unitless (%) |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Normalized Stiffness (VS/EO) Change per Day | 0.0001 unitless (%) |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Mean Normalized Stiffness (SS+VS/EO) at Enrollment | 1.381 unitless (%) |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Normalized Stiffness (SS+VS/EO) Change per Day | 0.0004 unitless (%) |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Normalized Stiffness (VS/EO) Change per Day | -0.0002 unitless (%) |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Mean Normalized Stiffness (SS+VS/EO) at Enrollment | 1.382 unitless (%) |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Normalized Stiffness (SS+VS/EO) Change per Day | -0.0004 unitless (%) |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Mean Normalized Stiffness (VS/EO) at Enrollment | 1.228 unitless (%) |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Mean Normalized Stiffness (SS+VS/EO) at Enrollment | 1.373 unitless (%) |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Normalized Stiffness (VS/EO) Change per Day | -0.00011 unitless (%) |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Normalized Stiffness (SS+VS/EO) Change per Day | -0.000046 unitless (%) |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Mean Normalized Stiffness (VS/EO) at Enrollment | 1.212 unitless (%) |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Normalized Stiffness (SS+VS/EO) Change per Day | -0.000030 unitless (%) |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Normalized Stiffness (VS/EO) Change per Day | -0.00017 unitless (%) |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Mean Normalized Stiffness (VS/EO) at Enrollment | 1.234 unitless (%) |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness | Estimated Mean Normalized Stiffness (SS+VS/EO) at Enrollment | 1.388 unitless (%) |
Comparison: Analysis for CSMI Outcome - Normalized Stiffness (VS/EO)p-value: 0.23795% CI: [-0.0002, 0.0007]Mixed Models Analysis
Comparison: Analysis for CSMI Outcome - Normalized Stiffness (SS+VS/EO)p-value: 0.00295% CI: [0.0003, 0.001]Mixed Models Analysis
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.
Time frame: 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)
Population: Some participants were not able to complete both conditions of the CSMI test.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Mean Time Delay (VS/EO) at Enrollment | 218.0 ms |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Time Delay (VS/EO) Change per Day | -0.217 ms |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Mean Time Delay (SS+VS/EO) at Enrollment | 171.0 ms |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Time Delay (SS+VS/EO) Change per Day | -0.169 ms |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Time Delay (SS+VS/EO) Change per Day | -0.027 ms |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Time Delay (VS/EO) Change per Day | 0.018 ms |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Mean Time Delay (VS/EO) at Enrollment | 211.0 ms |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Mean Time Delay (SS+VS/EO) at Enrollment | 170.0 ms |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Time Delay (VS/EO) Change per Day | -0.043 ms |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Mean Time Delay (VS/EO) at Enrollment | 213.6 ms |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Time Delay (SS+VS/EO) Change per Day | -0.076 ms |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Mean Time Delay (SS+VS/EO) at Enrollment | 169.5 ms |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Mean Time Delay (VS/EO) at Enrollment | 214.2 ms |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Time Delay (VS/EO) Change per Day | -0.0257 ms |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Mean Time Delay (SS+VS/EO) at Enrollment | 171.9 ms |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Time Delay | Estimated Time Delay (SS+VS/EO) Change per Day | -0.049 ms |
Comparison: Analysis for CSMI Outcome - Time Delay (VS/EO)p-value: <0.00195% CI: [-0.361, -0.11]Mixed Models Analysis
Comparison: Analysis for CSMI Outcome - Time Delay (SS+VS/EO)p-value: 0.00295% CI: [-0.233, -0.052]Mixed Models Analysis
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.
Time frame: 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)
Population: Some participants were not able to complete both conditions of the CSMI test.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Mean Visual Weighting (VS/EO) at Enrollment | 0.134 unitless (% of sensory system of balance |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Visual Weighting (VS/EO) Change per Day | -0.0004 unitless (% of sensory system of balance |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Mean Vestibular Weighting (SS+VS/EO) at Enrollment | 0.414 unitless (% of sensory system of balance |
| Earlier Physical Therapy | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Vestibular Weighting (SS+VS/EO) Change per Day | 0.0004 unitless (% of sensory system of balance |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Vestibular Weighting (SS+VS/EO) Change per Day | 0.0004 unitless (% of sensory system of balance |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Mean Vestibular Weighting (SS+VS/EO) at Enrollment | 0.415 unitless (% of sensory system of balance |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Visual Weighting (VS/EO) Change per Day | -0.0002 unitless (% of sensory system of balance |
| Later Physical Therapy (Standard of Care) | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Mean Visual Weighting (VS/EO) at Enrollment | 0.133 unitless (% of sensory system of balance |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Mean Vestibular Weighting (SS+VS/EO) at Enrollment | 0.413 unitless (% of sensory system of balance |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Vestibular Weighting (SS+VS/EO) Change per Day | 0.00033 unitless (% of sensory system of balance |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Visual Weighting (VS/EO) Change per Day | -0.00025 unitless (% of sensory system of balance |
| Physical Therapy With Home Monitoring | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Mean Visual Weighting (VS/EO) at Enrollment | 0.137 unitless (% of sensory system of balance |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Vestibular Weighting (SS+VS/EO) Change per Day | 0.00041 unitless (% of sensory system of balance |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Mean Visual Weighting (VS/EO) at Enrollment | 0.130 unitless (% of sensory system of balance |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Visual Weighting (VS/EO) Change per Day | -0.00021 unitless (% of sensory system of balance |
| Physical Therapy (Without Home Monitoring) | Central Sensorimotor Integration (CSMI) Test: Visual and Vestibular Weighting | Estimated Mean Vestibular Weighting (SS+VS/EO) at Enrollment | 0.416 unitless (% of sensory system of balance |
Comparison: Analysis for CSMI Outcome - Visual Weight (VS/EO)p-value: 0.01395% CI: [-0.0005, -0.0001]Mixed Models Analysis
Comparison: Analysis for CSMI Outcome - Vestibular Weight (SS+VS/EO)p-value: 0.7895% CI: [-0.0003, 0.0004]Mixed Models Analysis
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Complex Navigation Task | Estimated Mean Single Task Average Lap Time at Enrollment | 14.78 Seconds |
| Earlier Physical Therapy | Complex Navigation Task | Estimated Mean Auditory Stroop Task Average Lap Time at Enrollment | 14.76 Seconds |
| Earlier Physical Therapy | Complex Navigation Task | Estimated Single Task Average Lap Time Change per Day | -0.0322 Seconds |
| Earlier Physical Therapy | Complex Navigation Task | Estimated Auditory Stroop Task Average Lap Time Change per Day | -0.0300 Seconds |
| Later Physical Therapy (Standard of Care) | Complex Navigation Task | Estimated Mean Single Task Average Lap Time at Enrollment | 15.30 Seconds |
| Later Physical Therapy (Standard of Care) | Complex Navigation Task | Estimated Single Task Average Lap Time Change per Day | -0.0210 Seconds |
| Later Physical Therapy (Standard of Care) | Complex Navigation Task | Estimated Mean Auditory Stroop Task Average Lap Time at Enrollment | 15.40 Seconds |
| Later Physical Therapy (Standard of Care) | Complex Navigation Task | Estimated Auditory Stroop Task Average Lap Time Change per Day | -0.0190 Seconds |
| Physical Therapy With Home Monitoring | Complex Navigation Task | Estimated Mean Auditory Stroop Task Average Lap Time at Enrollment | 14.99 Seconds |
| Physical Therapy With Home Monitoring | Complex Navigation Task | Estimated Mean Single Task Average Lap Time at Enrollment | 14.94 Seconds |
| Physical Therapy With Home Monitoring | Complex Navigation Task | Estimated Auditory Stroop Task Average Lap Time Change per Day | -0.022 Seconds |
| Physical Therapy With Home Monitoring | Complex Navigation Task | Estimated Single Task Average Lap Time Change per Day | -0.022 Seconds |
| Physical Therapy (Without Home Monitoring) | Complex Navigation Task | Estimated Auditory Stroop Task Average Lap Time Change per Day | -0.022 Seconds |
| Physical Therapy (Without Home Monitoring) | Complex Navigation Task | Estimated Single Task Average Lap Time Change per Day | -0.024 Seconds |
| Physical Therapy (Without Home Monitoring) | Complex Navigation Task | Estimated Mean Single Task Average Lap Time at Enrollment | 15.22 Seconds |
| Physical Therapy (Without Home Monitoring) | Complex Navigation Task | Estimated Mean Auditory Stroop Task Average Lap Time at Enrollment | 15.27 Seconds |
Comparison: Analysis for Single Task Average Lap Timep-value: 0.04295% CI: [-0.0219, -0.0004]Mixed Models Analysis
Comparison: Analysis for Auditory Stroop Average Lap Timep-value: 0.031195% CI: [-0.0211, -0.001]Mixed Models Analysis
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.
Time frame: Earlier PT Group: Pre (week 0) and Post Physical Therapy (week 7) / Later PT Group: Pre (week 7), and Post Physical Therapy (week 14)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Dynamic Visual Acuity (DVA) | Pre Physical Therapy Horizonal DVA Lines Lost | 1.1 lines lost from static visual acuity |
| Earlier Physical Therapy | Dynamic Visual Acuity (DVA) | Post Physical Therapy Horizonal DVA Lines Lost | 0.8 lines lost from static visual acuity |
| Earlier Physical Therapy | Dynamic Visual Acuity (DVA) | Pre Physical Therapy Vertical DVA Lines Lost | 1.3 lines lost from static visual acuity |
| Earlier Physical Therapy | Dynamic Visual Acuity (DVA) | Post Physical Therapy Vertical DVA Lines Lost | 0.6 lines lost from static visual acuity |
| Later Physical Therapy (Standard of Care) | Dynamic Visual Acuity (DVA) | Post Physical Therapy Horizonal DVA Lines Lost | 0.8 lines lost from static visual acuity |
| Later Physical Therapy (Standard of Care) | Dynamic Visual Acuity (DVA) | Pre Physical Therapy Vertical DVA Lines Lost | 1.1 lines lost from static visual acuity |
| Later Physical Therapy (Standard of Care) | Dynamic Visual Acuity (DVA) | Post Physical Therapy Vertical DVA Lines Lost | 0.9 lines lost from static visual acuity |
| Later Physical Therapy (Standard of Care) | Dynamic Visual Acuity (DVA) | Pre Physical Therapy Horizonal DVA Lines Lost | 1.3 lines lost from static visual acuity |
| Physical Therapy With Home Monitoring | Dynamic Visual Acuity (DVA) | Pre Physical Therapy Vertical DVA Lines Lost | 1.5 lines lost from static visual acuity |
| Physical Therapy With Home Monitoring | Dynamic Visual Acuity (DVA) | Post Physical Therapy Horizonal DVA Lines Lost | 0.9 lines lost from static visual acuity |
| Physical Therapy With Home Monitoring | Dynamic Visual Acuity (DVA) | Post Physical Therapy Vertical DVA Lines Lost | 0.9 lines lost from static visual acuity |
| Physical Therapy With Home Monitoring | Dynamic Visual Acuity (DVA) | Pre Physical Therapy Horizonal DVA Lines Lost | 1.4 lines lost from static visual acuity |
| Physical Therapy (Without Home Monitoring) | Dynamic Visual Acuity (DVA) | Post Physical Therapy Vertical DVA Lines Lost | 0.9 lines lost from static visual acuity |
| Physical Therapy (Without Home Monitoring) | Dynamic Visual Acuity (DVA) | Post Physical Therapy Horizonal DVA Lines Lost | 1.1 lines lost from static visual acuity |
| Physical Therapy (Without Home Monitoring) | Dynamic Visual Acuity (DVA) | Pre Physical Therapy Horizonal DVA Lines Lost | 1.4 lines lost from static visual acuity |
| Physical Therapy (Without Home Monitoring) | Dynamic Visual Acuity (DVA) | Pre Physical Therapy Vertical DVA Lines Lost | 1.2 lines lost from static visual acuity |
Comparison: Analysis for Horizontal DVA Lines Lostp-value: 0.603995% CI: [-0.1503, 0.2574]Mixed Models Analysis
Comparison: Analysis for Vertical DVA Lines Lostp-value: 0.041495% CI: [-0.461, -0.0093]Mixed Models Analysis
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.
Time frame: 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)
Population: Two participants fell during EcFo test making the sway area invalid.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Instrumented Sway | Estimated EcFo Sway Area | -0.008 m^4/s^2 |
| Earlier Physical Therapy | Instrumented Sway | Estimated Mean EcFi Sway Area at Enrollment | 0.160 m^4/s^2 |
| Earlier Physical Therapy | Instrumented Sway | Estimated EcFi Sway Area Change per Day | -0.006 m^4/s^2 |
| Earlier Physical Therapy | Instrumented Sway | Estimated Mean EcFo Sway Area at Enrollment | 0.816 m^4/s^2 |
| Later Physical Therapy (Standard of Care) | Instrumented Sway | Estimated Mean EcFo Sway Area at Enrollment | 0.654 m^4/s^2 |
| Later Physical Therapy (Standard of Care) | Instrumented Sway | Estimated EcFo Sway Area | -0.003 m^4/s^2 |
| Later Physical Therapy (Standard of Care) | Instrumented Sway | Estimated Mean EcFi Sway Area at Enrollment | 0.237 m^4/s^2 |
| Later Physical Therapy (Standard of Care) | Instrumented Sway | Estimated EcFi Sway Area Change per Day | -0.003 m^4/s^2 |
| Physical Therapy With Home Monitoring | Instrumented Sway | Estimated Mean EcFo Sway Area at Enrollment | 0.687 m^4/s^2 |
| Physical Therapy With Home Monitoring | Instrumented Sway | Estimated EcFo Sway Area | -0.0021 m^4/s^2 |
| Physical Therapy With Home Monitoring | Instrumented Sway | Estimated EcFi Sway Area Change per Day | -0.0004 m^4/s^2 |
| Physical Therapy With Home Monitoring | Instrumented Sway | Estimated Mean EcFi Sway Area at Enrollment | 0.215 m^4/s^2 |
| Physical Therapy (Without Home Monitoring) | Instrumented Sway | Estimated EcFo Sway Area | -0.0032 m^4/s^2 |
| Physical Therapy (Without Home Monitoring) | Instrumented Sway | Estimated Mean EcFo Sway Area at Enrollment | 0.747 m^4/s^2 |
| Physical Therapy (Without Home Monitoring) | Instrumented Sway | Estimated Mean EcFi Sway Area at Enrollment | 0.198 m^4/s^2 |
| Physical Therapy (Without Home Monitoring) | Instrumented Sway | Estimated EcFi Sway Area Change per Day | -0.0008 m^4/s^2 |
Comparison: Analysis for EcFi conditionp-value: 0.2495% CI: [-0.007, 0.002]Mixed Models Analysis
Comparison: Analysis for EcFo conditionp-value: 0.00395% CI: [-0.009, -0.002]Mixed Models Analysis
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.
Time frame: 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)
Population: 1 Participant from the Later PT group was excluded from Single Task 180 Deg Turn Velocity because of not following directions correctly.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Instrumented Walking: 180 Degree Turn Velocity | Estimated Mean Single Task 180 Degree Turn Velocity at Enrollment | 208.22 degrees per second |
| Earlier Physical Therapy | Instrumented Walking: 180 Degree Turn Velocity | Estimated Change in Single Task 180 Degree Turn Velocity per Day | 0.261 degrees per second |
| Earlier Physical Therapy | Instrumented Walking: 180 Degree Turn Velocity | Estimated Mean Auditory Stroop 180 Degree Turn Velocity at Enrollment | 204.23 degrees per second |
| Earlier Physical Therapy | Instrumented Walking: 180 Degree Turn Velocity | Estimated Change in Auditory Stroop 180 Degree Turn Velocity per Day | 0.306 degrees per second |
| Later Physical Therapy (Standard of Care) | Instrumented Walking: 180 Degree Turn Velocity | Estimated Change in Single Task 180 Degree Turn Velocity per Day | 0.100 degrees per second |
| Later Physical Therapy (Standard of Care) | Instrumented Walking: 180 Degree Turn Velocity | Estimated Mean Auditory Stroop 180 Degree Turn Velocity at Enrollment | 193.13 degrees per second |
| Later Physical Therapy (Standard of Care) | Instrumented Walking: 180 Degree Turn Velocity | Estimated Change in Auditory Stroop 180 Degree Turn Velocity per Day | 0.0897 degrees per second |
| Later Physical Therapy (Standard of Care) | Instrumented Walking: 180 Degree Turn Velocity | Estimated Mean Single Task 180 Degree Turn Velocity at Enrollment | 194.78 degrees per second |
| Physical Therapy With Home Monitoring | Instrumented Walking: 180 Degree Turn Velocity | Estimated Mean Auditory Stroop 180 Degree Turn Velocity at Enrollment | 197.0 degrees per second |
| Physical Therapy With Home Monitoring | Instrumented Walking: 180 Degree Turn Velocity | Estimated Change in Single Task 180 Degree Turn Velocity per Day | 0.1263 degrees per second |
| Physical Therapy With Home Monitoring | Instrumented Walking: 180 Degree Turn Velocity | Estimated Change in Auditory Stroop 180 Degree Turn Velocity per Day | 0.1801 degrees per second |
| Physical Therapy With Home Monitoring | Instrumented Walking: 180 Degree Turn Velocity | Estimated Mean Single Task 180 Degree Turn Velocity at Enrollment | 201.2 degrees per second |
| Physical Therapy (Without Home Monitoring) | Instrumented Walking: 180 Degree Turn Velocity | Estimated Change in Auditory Stroop 180 Degree Turn Velocity per Day | 0.1099 degrees per second |
| Physical Therapy (Without Home Monitoring) | Instrumented Walking: 180 Degree Turn Velocity | Estimated Change in Single Task 180 Degree Turn Velocity per Day | 0.1841 degrees per second |
| Physical Therapy (Without Home Monitoring) | Instrumented Walking: 180 Degree Turn Velocity | Estimated Mean Single Task 180 Degree Turn Velocity at Enrollment | 199.4 degrees per second |
| Physical Therapy (Without Home Monitoring) | Instrumented Walking: 180 Degree Turn Velocity | Estimated Mean Auditory Stroop 180 Degree Turn Velocity at Enrollment | 198.2 degrees per second |
Comparison: Analysis for Single Task 180 Degree Turn Velocityp-value: 0.074295% CI: [-0.0159, 0.338]Mixed Models Analysis
Comparison: Analysis for Auditory Stroop 180 Degree Turn Velocityp-value: 0.012195% CI: [0.048, 0.385]Mixed Models Analysis
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.
Time frame: 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)
Population: 1 Participant from the Later PT group was excluded from Single Task 180 Deg Turn Velocity because of not following directions correctly.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Instrumented Walking: Gait Speed | Estimated Mean Single Task Gait Speed at Enrollment | 1.313 m/s |
| Earlier Physical Therapy | Instrumented Walking: Gait Speed | Estimated Change in Single Task Gait Speed per Day | 0.00083 m/s |
| Earlier Physical Therapy | Instrumented Walking: Gait Speed | Estimated Mean Auditory Stroop Gait Speed at Enrollment | 1.277 m/s |
| Earlier Physical Therapy | Instrumented Walking: Gait Speed | Estimated Change in Auditory Stroop Gait Speed per Day | 0.00083 m/s |
| Later Physical Therapy (Standard of Care) | Instrumented Walking: Gait Speed | Estimated Change in Single Task Gait Speed per Day | 0.00054 m/s |
| Later Physical Therapy (Standard of Care) | Instrumented Walking: Gait Speed | Estimated Mean Auditory Stroop Gait Speed at Enrollment | 1.227 m/s |
| Later Physical Therapy (Standard of Care) | Instrumented Walking: Gait Speed | Estimated Change in Auditory Stroop Gait Speed per Day | 0.00049 m/s |
| Later Physical Therapy (Standard of Care) | Instrumented Walking: Gait Speed | Estimated Mean Single Task Gait Speed at Enrollment | 1.255 m/s |
| Physical Therapy With Home Monitoring | Instrumented Walking: Gait Speed | Estimated Mean Auditory Stroop Gait Speed at Enrollment | 1.244 m/s |
| Physical Therapy With Home Monitoring | Instrumented Walking: Gait Speed | Estimated Change in Single Task Gait Speed per Day | 0.00062 m/s |
| Physical Therapy With Home Monitoring | Instrumented Walking: Gait Speed | Estimated Change in Auditory Stroop Gait Speed per Day | 0.00058 m/s |
| Physical Therapy With Home Monitoring | Instrumented Walking: Gait Speed | Estimated Mean Single Task Gait Speed at Enrollment | 1.289 m/s |
| Physical Therapy (Without Home Monitoring) | Instrumented Walking: Gait Speed | Estimated Change in Auditory Stroop Gait Speed per Day | 0.00060 m/s |
| Physical Therapy (Without Home Monitoring) | Instrumented Walking: Gait Speed | Estimated Change in Single Task Gait Speed per Day | 0.00063 m/s |
| Physical Therapy (Without Home Monitoring) | Instrumented Walking: Gait Speed | Estimated Mean Single Task Gait Speed at Enrollment | 1.283 m/s |
| Physical Therapy (Without Home Monitoring) | Instrumented Walking: Gait Speed | Estimated Mean Auditory Stroop Gait Speed at Enrollment | 1.263 m/s |
Comparison: Analysis for Single Task Gait Speedp-value: 0.322695% CI: [-0.0003, 0.00087]Mixed Models Analysis
Comparison: Analysis for Auditory Stroop Gait Speedp-value: 0.221895% CI: [-0.0002, 0.0009]Mixed Models Analysis
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.
Time frame: 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)
Population: 1 Participant from the Later PT group was excluded from Single Task 180 Deg Turn Velocity because of not following directions correctly.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Mean Single Task Percentage of Double Support of Gait Cycle at Enrollment | 19.18 % of Gait Cycle |
| Earlier Physical Therapy | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Change in Single Task Percentage of Double Support of Gait Cycle per Day | -0.0021 % of Gait Cycle |
| Earlier Physical Therapy | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Mean Auditory Stroop Percentage of Double Support of Gait Cycle at Enrollment | 19.77 % of Gait Cycle |
| Earlier Physical Therapy | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Change in Auditory Stroop Percentage of Double Support of Gait Cycle per Day | -0.00278 % of Gait Cycle |
| Later Physical Therapy (Standard of Care) | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Change in Single Task Percentage of Double Support of Gait Cycle per Day | -0.0027 % of Gait Cycle |
| Later Physical Therapy (Standard of Care) | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Mean Auditory Stroop Percentage of Double Support of Gait Cycle at Enrollment | 20.59 % of Gait Cycle |
| Later Physical Therapy (Standard of Care) | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Change in Auditory Stroop Percentage of Double Support of Gait Cycle per Day | -0.0018 % of Gait Cycle |
| Later Physical Therapy (Standard of Care) | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Mean Single Task Percentage of Double Support of Gait Cycle at Enrollment | 20.08 % of Gait Cycle |
| Physical Therapy With Home Monitoring | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Mean Auditory Stroop Percentage of Double Support of Gait Cycle at Enrollment | 20.61 % of Gait Cycle |
| Physical Therapy With Home Monitoring | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Change in Single Task Percentage of Double Support of Gait Cycle per Day | -0.0041 % of Gait Cycle |
| Physical Therapy With Home Monitoring | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Change in Auditory Stroop Percentage of Double Support of Gait Cycle per Day | -0.0029 % of Gait Cycle |
| Physical Therapy With Home Monitoring | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Mean Single Task Percentage of Double Support of Gait Cycle at Enrollment | 19.88 % of Gait Cycle |
| Physical Therapy (Without Home Monitoring) | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Change in Auditory Stroop Percentage of Double Support of Gait Cycle per Day | -0.0022 % of Gait Cycle |
| Physical Therapy (Without Home Monitoring) | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Change in Single Task Percentage of Double Support of Gait Cycle per Day | -0.0015 % of Gait Cycle |
| Physical Therapy (Without Home Monitoring) | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Mean Single Task Percentage of Double Support of Gait Cycle at Enrollment | 19.59 % of Gait Cycle |
| Physical Therapy (Without Home Monitoring) | Instrumented Walking: Percentage of Double Support of Gait Cycle | Estimated Mean Auditory Stroop Percentage of Double Support of Gait Cycle at Enrollment | 19.96 % of Gait Cycle |
Comparison: Analysis for Single Task Percentage of Double Support Time of Gait Cyclep-value: 0.890695% CI: [-0.0084, 0.00961]Mixed Models Analysis
Comparison: Analysis for Auditory Stroop Percentage of Double Support Time of Gait Cyclep-value: 0.844795% CI: [-0.0107, 0.00874]Mixed Models Analysis
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Mini-Balance Evaluation Systems Test (Mini-BESTest) | Estimated Mean at Enrollment | 24.8 score on a scale |
| Earlier Physical Therapy | Mini-Balance Evaluation Systems Test (Mini-BESTest) | Estimated Change per Day | 0.019 score on a scale |
| Later Physical Therapy (Standard of Care) | Mini-Balance Evaluation Systems Test (Mini-BESTest) | Estimated Change per Day | 0.011 score on a scale |
| Later Physical Therapy (Standard of Care) | Mini-Balance Evaluation Systems Test (Mini-BESTest) | Estimated Mean at Enrollment | 24.4 score on a scale |
| Physical Therapy With Home Monitoring | Mini-Balance Evaluation Systems Test (Mini-BESTest) | Estimated Mean at Enrollment | 24.4 score on a scale |
| Physical Therapy With Home Monitoring | Mini-Balance Evaluation Systems Test (Mini-BESTest) | Estimated Change per Day | 0.011 score on a scale |
| Physical Therapy (Without Home Monitoring) | Mini-Balance Evaluation Systems Test (Mini-BESTest) | Estimated Mean at Enrollment | 24.7 score on a scale |
| Physical Therapy (Without Home Monitoring) | Mini-Balance Evaluation Systems Test (Mini-BESTest) | Estimated Change per Day | 0.013 score on a scale |
p-value: 0.13595% CI: [-0.003, 0.019]Mixed Models Analysis
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Modified Balance Error Scoring System (mBESS) | Estimated Mean at Enrollment | 6.1 score on a scale |
| Earlier Physical Therapy | Modified Balance Error Scoring System (mBESS) | Estimated Change per Day | -0.0229 score on a scale |
| Later Physical Therapy (Standard of Care) | Modified Balance Error Scoring System (mBESS) | Estimated Change per Day | -0.0122 score on a scale |
| Later Physical Therapy (Standard of Care) | Modified Balance Error Scoring System (mBESS) | Estimated Mean at Enrollment | 6.6 score on a scale |
| Physical Therapy With Home Monitoring | Modified Balance Error Scoring System (mBESS) | Estimated Mean at Enrollment | 6.6 score on a scale |
| Physical Therapy With Home Monitoring | Modified Balance Error Scoring System (mBESS) | Estimated Change per Day | 0.0003 score on a scale |
| Physical Therapy (Without Home Monitoring) | Modified Balance Error Scoring System (mBESS) | Estimated Mean at Enrollment | 6.2 score on a scale |
| Physical Therapy (Without Home Monitoring) | Modified Balance Error Scoring System (mBESS) | Estimated Change per Day | -0.024 score on a scale |
p-value: 0.40695% CI: [-0.036, 0.0146]Mixed Models Analysis
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Neurobehavioral Symptom Inventory (NSI) | Estimated Mean at Enrollment | 39.1 score on a scale |
| Earlier Physical Therapy | Neurobehavioral Symptom Inventory (NSI) | Estimated Change per Day | -0.259 score on a scale |
| Later Physical Therapy (Standard of Care) | Neurobehavioral Symptom Inventory (NSI) | Estimated Change per Day | -0.186 score on a scale |
| Later Physical Therapy (Standard of Care) | Neurobehavioral Symptom Inventory (NSI) | Estimated Mean at Enrollment | 43.5 score on a scale |
| Physical Therapy With Home Monitoring | Neurobehavioral Symptom Inventory (NSI) | Estimated Mean at Enrollment | 42.7 score on a scale |
| Physical Therapy With Home Monitoring | Neurobehavioral Symptom Inventory (NSI) | Estimated Change per Day | -0.23 score on a scale |
| Physical Therapy (Without Home Monitoring) | Neurobehavioral Symptom Inventory (NSI) | Estimated Mean at Enrollment | 40.9 score on a scale |
| Physical Therapy (Without Home Monitoring) | Neurobehavioral Symptom Inventory (NSI) | Estimated Change per Day | -0.189 score on a scale |
p-value: 0.01395% CI: [-0.13, -0.016]Mixed Models Analysis
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.
Time frame: Earlier PT Group: Post PT (week 7) / Later PT Group: Post PT (week 14)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Earlier Physical Therapy | Patient Global Impression of Change (PGIC) | 6 score on a scale |
| Later Physical Therapy (Standard of Care) | Patient Global Impression of Change (PGIC) | 6 score on a scale |
| Physical Therapy With Home Monitoring | Patient Global Impression of Change (PGIC) | 6 score on a scale |
| Physical Therapy (Without Home Monitoring) | Patient Global Impression of Change (PGIC) | 6 score on a scale |
p-value: 0.5158Wilcoxon (Mann-Whitney)
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Quality of Life After Brain Injury (QOLIBRI) | Estimated Mean at Enrollment | 49.7 Percent |
| Earlier Physical Therapy | Quality of Life After Brain Injury (QOLIBRI) | Estimated Change per Day | 0.277 Percent |
| Later Physical Therapy (Standard of Care) | Quality of Life After Brain Injury (QOLIBRI) | Estimated Mean at Enrollment | 45.7 Percent |
| Later Physical Therapy (Standard of Care) | Quality of Life After Brain Injury (QOLIBRI) | Estimated Change per Day | 0.179 Percent |
| Physical Therapy With Home Monitoring | Quality of Life After Brain Injury (QOLIBRI) | Estimated Mean at Enrollment | 47.9 Percent |
| Physical Therapy With Home Monitoring | Quality of Life After Brain Injury (QOLIBRI) | Estimated Change per Day | 0.201 Percent |
| Physical Therapy (Without Home Monitoring) | Quality of Life After Brain Injury (QOLIBRI) | Estimated Change per Day | 0.192 Percent |
| Physical Therapy (Without Home Monitoring) | Quality of Life After Brain Injury (QOLIBRI) | Estimated Mean at Enrollment | 46.8 Percent |
p-value: 0.0195% CI: [0.024, 0.173]Mixed Models Analysis
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Return to Activity Question | Estimated Mean at Enrollment | 59.8 Percent (%) |
| Earlier Physical Therapy | Return to Activity Question | Estimated Change per Day | 0.277 Percent (%) |
| Later Physical Therapy (Standard of Care) | Return to Activity Question | Estimated Change per Day | 0.236 Percent (%) |
| Later Physical Therapy (Standard of Care) | Return to Activity Question | Estimated Mean at Enrollment | 54.2 Percent (%) |
| Physical Therapy With Home Monitoring | Return to Activity Question | Estimated Mean at Enrollment | 54.1 Percent (%) |
| Physical Therapy With Home Monitoring | Return to Activity Question | Estimated Change per Day | 0.266 Percent (%) |
| Physical Therapy (Without Home Monitoring) | Return to Activity Question | Estimated Mean at Enrollment | 58.5 Percent (%) |
| Physical Therapy (Without Home Monitoring) | Return to Activity Question | Estimated Change per Day | 0.224 Percent (%) |
p-value: 0.4595% CI: [-0.0648, 0.146]Mixed Models Analysis
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Vestibular/Ocular-Motor Screening (VOMS) Tool | Estimated Mean at Enrollment | 14.4 score on a scale |
| Earlier Physical Therapy | Vestibular/Ocular-Motor Screening (VOMS) Tool | Estimated Change per Day | -0.131 score on a scale |
| Later Physical Therapy (Standard of Care) | Vestibular/Ocular-Motor Screening (VOMS) Tool | Estimated Change per Day | -0.103 score on a scale |
| Later Physical Therapy (Standard of Care) | Vestibular/Ocular-Motor Screening (VOMS) Tool | Estimated Mean at Enrollment | 14.6 score on a scale |
| Physical Therapy With Home Monitoring | Vestibular/Ocular-Motor Screening (VOMS) Tool | Estimated Mean at Enrollment | 14.9 score on a scale |
| Physical Therapy With Home Monitoring | Vestibular/Ocular-Motor Screening (VOMS) Tool | Estimated Change per Day | -0.091 score on a scale |
| Physical Therapy (Without Home Monitoring) | Vestibular/Ocular-Motor Screening (VOMS) Tool | Estimated Mean at Enrollment | 14.3 score on a scale |
| Physical Therapy (Without Home Monitoring) | Vestibular/Ocular-Motor Screening (VOMS) Tool | Estimated Change per Day | -0.116 score on a scale |
p-value: 0.38795% CI: [-0.09, 0.035]Mixed Models Analysis
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Head Impact Test (HIT) - 6 | Estimated Mean at Enrollment | 61.7 score on a scale |
| Earlier Physical Therapy | Head Impact Test (HIT) - 6 | Estimated Change per Day | -0.123 score on a scale |
| Later Physical Therapy (Standard of Care) | Head Impact Test (HIT) - 6 | Estimated Change per Day | -0.0819 score on a scale |
| Later Physical Therapy (Standard of Care) | Head Impact Test (HIT) - 6 | Estimated Mean at Enrollment | 62.5 score on a scale |
| Physical Therapy With Home Monitoring | Head Impact Test (HIT) - 6 | Estimated Change per Day | -0.110 score on a scale |
| Physical Therapy With Home Monitoring | Head Impact Test (HIT) - 6 | Estimated Mean at Enrollment | 62.4 score on a scale |
| Physical Therapy (Without Home Monitoring) | Head Impact Test (HIT) - 6 | Estimated Change per Day | -0.076 score on a scale |
| Physical Therapy (Without Home Monitoring) | Head Impact Test (HIT) - 6 | Estimated Mean at Enrollment | 62.0 score on a scale |
p-value: 0.03395% CI: [-0.0779, -0.0032]Mixed Models Analysis
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Insomnia Severity Index (ISI) | Estimated Change per Day | -0.0725 score on a scale |
| Earlier Physical Therapy | Insomnia Severity Index (ISI) | Estimated Mean at Enrollment | 14.0 score on a scale |
| Later Physical Therapy (Standard of Care) | Insomnia Severity Index (ISI) | Estimated Change per Day | -0.0590 score on a scale |
| Later Physical Therapy (Standard of Care) | Insomnia Severity Index (ISI) | Estimated Mean at Enrollment | 16.1 score on a scale |
| Physical Therapy With Home Monitoring | Insomnia Severity Index (ISI) | Estimated Change per Day | -0.060 score on a scale |
| Physical Therapy With Home Monitoring | Insomnia Severity Index (ISI) | Estimated Mean at Enrollment | 15.5 score on a scale |
| Physical Therapy (Without Home Monitoring) | Insomnia Severity Index (ISI) | Estimated Mean at Enrollment | 15.0 score on a scale |
| Physical Therapy (Without Home Monitoring) | Insomnia Severity Index (ISI) | Estimated Change per Day | -0.059 score on a scale |
p-value: 0.33695% CI: [-0.0413, 0.0142]Mixed Models Analysis
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.
Time frame: Collected weekly throughout study duration (week 0 to week 14).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Earlier Physical Therapy | Post-concussion Symptom Scale From the Sport Concussion Assessment (SCAT) Tool Version 5 | Estimated Mean at Enrollment | 56.5 score on a scale |
| Earlier Physical Therapy | Post-concussion Symptom Scale From the Sport Concussion Assessment (SCAT) Tool Version 5 | Estimated Change per Day | -0.349 score on a scale |
| Later Physical Therapy (Standard of Care) | Post-concussion Symptom Scale From the Sport Concussion Assessment (SCAT) Tool Version 5 | Estimated Change per Day | -0.317 score on a scale |
| Later Physical Therapy (Standard of Care) | Post-concussion Symptom Scale From the Sport Concussion Assessment (SCAT) Tool Version 5 | Estimated Mean at Enrollment | 58.8 score on a scale |
| Physical Therapy With Home Monitoring | Post-concussion Symptom Scale From the Sport Concussion Assessment (SCAT) Tool Version 5 | Estimated Mean at Enrollment | 59.0 score on a scale |
| Physical Therapy With Home Monitoring | Post-concussion Symptom Scale From the Sport Concussion Assessment (SCAT) Tool Version 5 | Estimated Change per Day | -0.361 score on a scale |
| Physical Therapy (Without Home Monitoring) | Post-concussion Symptom Scale From the Sport Concussion Assessment (SCAT) Tool Version 5 | Estimated Mean at Enrollment | 56.9 score on a scale |
| Physical Therapy (Without Home Monitoring) | Post-concussion Symptom Scale From the Sport Concussion Assessment (SCAT) Tool Version 5 | Estimated Change per Day | -0.313 score on a scale |
p-value: 0.322195% CI: [-0.0957, 0.0315]Mixed Models Analysis