Trial Outcomes & Findings for Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes in mTBI? (NCT NCT03479541)
NCT ID: NCT03479541
Last Updated: 2025-06-24
Results Overview
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.
COMPLETED
NA
203 participants
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)
2025-06-24
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
|
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.
|
Physical Therapy With Home Monitoring
Wearable sensors were worn during home exercises and biofeedback was reviewed in the next physical therapy appointment.
|
Physical Therapy (Without Home Monitoring)
Home exercise was completed without wearable sensors, and biofeedback was not given on home exercise performance.
|
|---|---|---|---|---|
|
Early and Late Physical Therapy
STARTED
|
82
|
121
|
0
|
0
|
|
Early and Late Physical Therapy
Started Physical Therapy
|
75
|
81
|
0
|
0
|
|
Early and Late Physical Therapy
Completed Post-Physical Therapy Assessments
|
63
|
63
|
0
|
0
|
|
Early and Late Physical Therapy
COMPLETED
|
63
|
63
|
0
|
0
|
|
Early and Late Physical Therapy
NOT COMPLETED
|
19
|
58
|
0
|
0
|
|
Home Monitoring
STARTED
|
0
|
0
|
93
|
110
|
|
Home Monitoring
Started Physical Therapy
|
0
|
0
|
73
|
83
|
|
Home Monitoring
Completed Post-Physical Therapy Assessments
|
0
|
0
|
64
|
62
|
|
Home Monitoring
COMPLETED
|
0
|
0
|
64
|
62
|
|
Home Monitoring
NOT COMPLETED
|
0
|
0
|
29
|
48
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Physical Therapy With Home Monitoring
Wearable sensors were worn during home exercises and biofeedback was reviewed in the next physical therapy appointment.
|
Physical Therapy (Without Home Monitoring)
Home exercise was completed without wearable sensors, and biofeedback was not given on home exercise performance.
|
|---|---|---|---|---|
|
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
|
|
Early and Late Physical Therapy
Early Termination - PI Decision
|
2
|
8
|
0
|
0
|
|
Home Monitoring
Lost to Follow-up
|
0
|
0
|
8
|
12
|
|
Home Monitoring
Withdrawal by Subject
|
0
|
0
|
17
|
30
|
|
Home Monitoring
Early Termination - PI Decision
|
0
|
0
|
4
|
6
|
Baseline Characteristics
Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes in mTBI?
Baseline characteristics by cohort
| Measure |
Earlier Physical Therapy
n=81 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
35.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
63 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Other
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=5 Participants
|
121 participants
n=7 Participants
|
202 participants
n=5 Participants
|
|
Body Mass Index
|
25.1 kg/m2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
27.3 kg/m2
STANDARD_DEVIATION 8.0 • n=7 Participants
|
26.4 kg/m2
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Days Since Injury at Enrollment
|
45.9 days
STANDARD_DEVIATION 20.1 • n=5 Participants
|
45.4 days
STANDARD_DEVIATION 22.4 • n=7 Participants
|
45.6 days
STANDARD_DEVIATION 21.5 • n=5 Participants
|
|
Injury Mechanism
bike-related
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Injury Mechanism
fall
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Injury Mechanism
motor vehicle accident
|
24 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Injury Mechanism
other
|
19 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Injury Mechanism
sport-related
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
mild traumatic brain injury (mTBI) History
No
|
43 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
mild traumatic brain injury (mTBI) History
Yes
|
38 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Dizziness Handicap Inventory (DHI)
Estimated Mean at Enrollment
|
29.2 score on a scale
Interval 25.4 to 33.0
|
34.9 score on a scale
Interval 31.4 to 38.4
|
33.3 score on a scale
Interval 29.5 to 37.1
|
32.1 score on a scale
Interval 28.3 to 35.9
|
|
Dizziness Handicap Inventory (DHI)
Estimated Change per Day
|
-0.202 score on a scale
Interval -0.272 to -0.132
|
-0.105 score on a scale
Interval -0.137 to -0.073
|
-0.133 score on a scale
Interval -0.177 to -0.09
|
-0.102 score on a scale
Interval -0.145 to -0.06
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Neurobehavioral Symptom Inventory (NSI)
Estimated Mean at Enrollment
|
39.1 score on a scale
Interval 36.3 to 41.9
|
43.5 score on a scale
Interval 41.1 to 45.9
|
42.7 score on a scale
Interval 39.9 to 45.5
|
40.9 score on a scale
Interval 38.3 to 43.5
|
|
Neurobehavioral Symptom Inventory (NSI)
Estimated Change per Day
|
-0.259 score on a scale
Interval -0.311 to -0.207
|
-0.186 score on a scale
Interval -0.21 to -0.162
|
-0.23 score on a scale
Interval -0.235 to -0.17
|
-0.189 score on a scale
Interval -0.221 to -0.158
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Quality of Life After Brain Injury (QOLIBRI)
Estimated Mean at Enrollment
|
49.7 Percent
Interval 46.5 to 52.9
|
45.7 Percent
Interval 43.1 to 48.3
|
47.9 Percent
Interval 44.6 to 51.2
|
46.8 Percent
Interval 44.2 to 49.4
|
|
Quality of Life After Brain Injury (QOLIBRI)
Estimated Change per Day
|
0.277 Percent
Interval 0.209 to 0.345
|
0.179 Percent
Interval 0.148 to 0.21
|
0.201 Percent
Interval 0.159 to 0.242
|
0.192 Percent
Interval 0.152 to 0.232
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=63 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=63 Participants
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.
|
Physical Therapy With Home Monitoring
n=64 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=62 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Patient Global Impression of Change (PGIC)
|
6 score on a scale
Interval 5.0 to 7.0
|
6 score on a scale
Interval 5.0 to 7.0
|
6 score on a scale
Interval 5.0 to 7.0
|
6 score on a scale
Interval 5.0 to 7.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Return to Activity Question
Estimated Mean at Enrollment
|
59.8 Percent (%)
Interval 55.9 to 63.7
|
54.2 Percent (%)
Interval 50.4 to 58.1
|
54.1 Percent (%)
Interval 48.9 to 58.9
|
58.5 Percent (%)
Interval 54.8 to 62.2
|
|
Return to Activity Question
Estimated Change per Day
|
0.277 Percent (%)
Interval 0.182 to 0.372
|
0.236 Percent (%)
Interval 0.192 to 0.281
|
0.266 Percent (%)
Interval 0.208 to 0.324
|
0.224 Percent (%)
Interval 0.169 to 0.279
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=74 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=79 Participants
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.
|
Physical Therapy With Home Monitoring
n=72 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=80 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Dynamic Visual Acuity (DVA)
Pre Physical Therapy Horizonal DVA Lines Lost
|
1.1 lines lost from static visual acuity
Interval 0.5 to 1.6
|
1.3 lines lost from static visual acuity
Interval 0.7 to 1.8
|
1.4 lines lost from static visual acuity
Interval 1.0 to 1.8
|
1.4 lines lost from static visual acuity
Interval 1.1 to 1.7
|
|
Dynamic Visual Acuity (DVA)
Pre Physical Therapy Vertical DVA Lines Lost
|
1.3 lines lost from static visual acuity
Interval 0.8 to 1.8
|
1.1 lines lost from static visual acuity
Interval 0.7 to 1.6
|
1.5 lines lost from static visual acuity
Interval 1.0 to 1.9
|
1.2 lines lost from static visual acuity
Interval 1.0 to 1.4
|
|
Dynamic Visual Acuity (DVA)
Post Physical Therapy Vertical DVA Lines Lost
|
0.6 lines lost from static visual acuity
Interval 0.1 to 1.2
|
0.9 lines lost from static visual acuity
Interval 0.4 to 1.4
|
0.9 lines lost from static visual acuity
Interval 0.7 to 1.2
|
0.9 lines lost from static visual acuity
Interval 0.6 to 1.2
|
|
Dynamic Visual Acuity (DVA)
Post Physical Therapy Horizonal DVA Lines Lost
|
0.8 lines lost from static visual acuity
Interval 0.2 to 1.4
|
0.8 lines lost from static visual acuity
Interval 0.3 to 1.3
|
0.9 lines lost from static visual acuity
Interval 0.7 to 1.2
|
1.1 lines lost from static visual acuity
Interval 0.8 to 1.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Vestibular/Ocular-Motor Screening (VOMS) Tool
Estimated Mean at Enrollment
|
14.4 score on a scale
Interval 11.7 to 17.1
|
14.6 score on a scale
Interval 12.6 to 16.6
|
14.9 score on a scale
Interval 12.5 to 17.2
|
14.3 score on a scale
Interval 11.8 to 16.8
|
|
Vestibular/Ocular-Motor Screening (VOMS) Tool
Estimated Change per Day
|
-0.131 score on a scale
Interval -0.188 to -0.074
|
-0.103 score on a scale
Interval -0.129 to -0.077
|
-0.091 score on a scale
Interval -0.125 to -0.056
|
-0.116 score on a scale
Interval -0.149 to -0.083
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Estimated Mean at Enrollment
|
24.8 score on a scale
Interval 24.3 to 25.3
|
24.4 score on a scale
Interval 24.0 to 24.8
|
24.4 score on a scale
Interval 23.8 to 24.9
|
24.7 score on a scale
Interval 24.3 to 25.1
|
|
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Estimated Change per Day
|
0.019 score on a scale
Interval 0.009 to 0.029
|
0.011 score on a scale
Interval 0.006 to 0.015
|
0.011 score on a scale
Interval 0.005 to 0.017
|
0.013 score on a scale
Interval 0.008 to 0.019
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Modified Balance Error Scoring System (mBESS)
Estimated Mean at Enrollment
|
6.1 score on a scale
Interval 4.9 to 7.4
|
6.6 score on a scale
Interval 5.5 to 7.6
|
6.6 score on a scale
Interval 5.2 to 7.9
|
6.2 score on a scale
Interval 5.2 to 7.3
|
|
Modified Balance Error Scoring System (mBESS)
Estimated Change per Day
|
-0.0229 score on a scale
Interval -0.0459 to 0.00021
|
-0.0122 score on a scale
Interval -0.0226 to -0.0018
|
0.0003 score on a scale
Interval -0.013 to 0.0135
|
-0.024 score on a scale
Interval -0.037 to -0.011
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Automated Neuropsychological Assessment Metrics (ANAM)
Estimated Change per Day
|
0.00647 score on a scale
Interval 0.00243 to 0.0105
|
0.00256 score on a scale
Interval 0.000716 to 0.0044
|
0.0028 score on a scale
Interval 0.0003 to 0.0053
|
0.0034 score on a scale
Interval 0.0011 to 0.0057
|
|
Automated Neuropsychological Assessment Metrics (ANAM)
Estimated Mean at Enrollment
|
-0.730 score on a scale
Interval -0.933 to -0.527
|
-0.732 score on a scale
Interval -0.922 to -0.543
|
-0.787 score on a scale
Interval -0.985 to -0.588
|
-0.685 score on a scale
Interval -0.892 to -0.478
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Instrumented Sway
Estimated EcFi Sway Area Change per Day
|
-0.006 m^4/s^2
Interval -0.01 to -0.001
|
-0.003 m^4/s^2
Interval -0.005 to -0.001
|
-0.0004 m^4/s^2
Interval -0.0013 to 0.0005
|
-0.0008 m^4/s^2
Interval -0.0017 to 0.0001
|
|
Instrumented Sway
Estimated EcFo Sway Area
|
-0.008 m^4/s^2
Interval -0.011 to -0.005
|
-0.003 m^4/s^2
Interval -0.004 to -0.001
|
-0.0021 m^4/s^2
Interval -0.0041 to -0.0002
|
-0.0032 m^4/s^2
Interval -0.0051 to -0.0013
|
|
Instrumented Sway
Estimated Mean EcFi Sway Area at Enrollment
|
0.160 m^4/s^2
Interval 0.128 to 0.192
|
0.237 m^4/s^2
Interval 0.16 to 0.314
|
0.215 m^4/s^2
Interval 0.145 to 0.286
|
0.198 m^4/s^2
Interval 0.129 to 0.267
|
|
Instrumented Sway
Estimated Mean EcFo Sway Area at Enrollment
|
0.816 m^4/s^2
Interval 0.394 to 1.238
|
0.654 m^4/s^2
Interval 0.546 to 0.762
|
0.687 m^4/s^2
Interval 0.554 to 0.82
|
0.747 m^4/s^2
Interval 0.419 to 1.075
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Complex Navigation Task
Estimated Mean Single Task Average Lap Time at Enrollment
|
14.78 Seconds
Interval 14.16 to 15.39
|
15.30 Seconds
Interval 14.85 to 15.75
|
14.94 Seconds
Interval 14.36 to 15.52
|
15.22 Seconds
Interval 14.72 to 15.73
|
|
Complex Navigation Task
Estimated Mean Auditory Stroop Task Average Lap Time at Enrollment
|
14.76 Seconds
Interval 14.19 to 15.34
|
15.40 Seconds
Interval 14.92 to 15.88
|
14.99 Seconds
Interval 14.38 to 15.6
|
15.27 Seconds
Interval 14.77 to 15.78
|
|
Complex Navigation Task
Estimated Auditory Stroop Task Average Lap Time Change per Day
|
-0.0300 Seconds
Interval -0.0393 to -0.0208
|
-0.0190 Seconds
Interval -0.023 to -0.015
|
-0.022 Seconds
Interval -0.027 to -0.017
|
-0.022 Seconds
Interval -0.027 to -0.016
|
|
Complex Navigation Task
Estimated Single Task Average Lap Time Change per Day
|
-0.0322 Seconds
Interval -0.0421 to -0.0223
|
-0.0210 Seconds
Interval -0.0253 to -0.0168
|
-0.022 Seconds
Interval -0.028 to -0.0165
|
-0.024 Seconds
Interval -0.03 to -0.019
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Instrumented Walking: Gait Speed
Estimated Change in Single Task Gait Speed per Day
|
0.00083 m/s
Interval 0.0003 to 0.00136
|
0.00054 m/s
Interval 0.00031 to 0.00077
|
0.00062 m/s
Interval 0.0003 to 0.00093
|
0.00063 m/s
Interval 0.00032 to 0.00093
|
|
Instrumented Walking: Gait Speed
Estimated Mean Auditory Stroop Gait Speed at Enrollment
|
1.277 m/s
Interval 1.243 to 1.311
|
1.227 m/s
Interval 1.195 to 1.259
|
1.244 m/s
Interval 1.204 to 1.284
|
1.263 m/s
Interval 1.231 to 1.295
|
|
Instrumented Walking: Gait Speed
Estimated Change in Auditory Stroop Gait Speed per Day
|
0.00083 m/s
Interval 0.00032 to 0.00134
|
0.00049 m/s
Interval 0.00026 to 0.00071
|
0.00058 m/s
Interval 0.00028 to 0.00089
|
0.00060 m/s
Interval 0.0003 to 0.00089
|
|
Instrumented Walking: Gait Speed
Estimated Mean Single Task Gait Speed at Enrollment
|
1.313 m/s
Interval 1.279 to 1.348
|
1.255 m/s
Interval 1.225 to 1.286
|
1.289 m/s
Interval 1.252 to 1.326
|
1.283 m/s
Interval 1.251 to 1.341
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Instrumented Walking: 180 Degree Turn Velocity
Estimated Mean Single Task 180 Degree Turn Velocity at Enrollment
|
208.22 degrees per second
Interval 199.42 to 217.03
|
194.78 degrees per second
Interval 187.72 to 201.84
|
201.2 degrees per second
Interval 191.6 to 210.7
|
199.4 degrees per second
Interval 192.3 to 206.5
|
|
Instrumented Walking: 180 Degree Turn Velocity
Estimated Change in Single Task 180 Degree Turn Velocity per Day
|
0.261 degrees per second
Interval 0.0999 to 0.422
|
0.100 degrees per second
Interval 0.0275 to 0.173
|
0.1263 degrees per second
Interval 0.0153 to 0.2372
|
0.1841 degrees per second
Interval 0.077 to 0.2911
|
|
Instrumented Walking: 180 Degree Turn Velocity
Estimated Mean Auditory Stroop 180 Degree Turn Velocity at Enrollment
|
204.23 degrees per second
Interval 195.82 to 212.64
|
193.13 degrees per second
Interval 185.54 to 200.73
|
197.0 degrees per second
Interval 187.6 to 206.3
|
198.2 degrees per second
Interval 190.7 to 205.8
|
|
Instrumented Walking: 180 Degree Turn Velocity
Estimated Change in Auditory Stroop 180 Degree Turn Velocity per Day
|
0.306 degrees per second
Interval 0.152 to 0.461
|
0.0897 degrees per second
Interval 0.0211 to 0.158
|
0.1801 degrees per second
Interval 0.0904 to 0.2697
|
0.1099 degrees per second
Interval 0.0231 to 0.1967
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
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
Interval -0.0117 to 0.00612
|
-0.0018 % of Gait Cycle
Interval -0.0057 to 0.00205
|
-0.0029 % of Gait Cycle
Interval -0.0079 to 0.002
|
-0.0022 % of Gait Cycle
Interval -0.0071 to 0.0026
|
|
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
Interval 18.57 to 19.79
|
20.08 % of Gait Cycle
Interval 19.44 to 20.72
|
19.88 % of Gait Cycle
Interval 19.16 to 20.59
|
19.59 % of Gait Cycle
Interval 18.94 to 20.23
|
|
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
Interval -0.0104 to 0.00614
|
-0.0027 % of Gait Cycle
Interval -0.0063 to 0.00082
|
-0.0041 % of Gait Cycle
Interval -0.0089 to 0.00068
|
-0.0015 % of Gait Cycle
Interval -0.0061 to 0.0032
|
|
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
Interval 19.14 to 20.39
|
20.59 % of Gait Cycle
Interval 19.92 to 21.26
|
20.61 % of Gait Cycle
Interval 19.85 to 21.36
|
19.96 % of Gait Cycle
Interval 19.31 to 20.61
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
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
Interval 0.121 to 0.147
|
0.133 unitless (% of sensory system of balance
Interval 0.122 to 0.144
|
0.137 unitless (% of sensory system of balance
Interval 0.124 to 0.15
|
0.130 unitless (% of sensory system of balance
Interval 0.118 to 0.142
|
|
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
Interval -0.0006 to -0.0002
|
-0.0002 unitless (% of sensory system of balance
Interval -0.0003 to -0.0001
|
-0.00025 unitless (% of sensory system of balance
Interval -0.00037 to -0.00013
|
-0.00021 unitless (% of sensory system of balance
Interval -0.00033 to -0.00009
|
|
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
Interval 0.393 to 0.435
|
0.415 unitless (% of sensory system of balance
Interval 0.401 to 0.429
|
0.413 unitless (% of sensory system of balance
Interval 0.393 to 0.434
|
0.416 unitless (% of sensory system of balance
Interval 0.4 to 0.432
|
|
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
Interval 0.0001 to 0.0008
|
0.0004 unitless (% of sensory system of balance
Interval 0.0002 to 0.0005
|
0.00033 unitless (% of sensory system of balance
Interval 0.00012 to 0.00054
|
0.00041 unitless (% of sensory system of balance
Interval 0.00021 to 0.00062
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Central Sensorimotor Integration (CSMI) Test: Time Delay
Estimated Time Delay (VS/EO) Change per Day
|
-0.217 ms
Interval -0.33 to -0.104
|
0.018 ms
Interval -0.036 to 0.073
|
-0.043 ms
Interval -0.115 to 0.028
|
-0.0257 ms
Interval -0.095 to 0.043
|
|
Central Sensorimotor Integration (CSMI) Test: Time Delay
Estimated Mean Time Delay (VS/EO) at Enrollment
|
218.0 ms
Interval 211.5 to 224.5
|
211.0 ms
Interval 206.7 to 215.3
|
213.6 ms
Interval 207.1 to 220.0
|
214.2 ms
Interval 209.2 to 219.2
|
|
Central Sensorimotor Integration (CSMI) Test: Time Delay
Estimated Mean Time Delay (SS+VS/EO) at Enrollment
|
171.0 ms
Interval 165.6 to 176.4
|
170.0 ms
Interval 166.6 to 173.4
|
169.5 ms
Interval 164.6 to 174.4
|
171.9 ms
Interval 167.6 to 176.2
|
|
Central Sensorimotor Integration (CSMI) Test: Time Delay
Estimated Time Delay (SS+VS/EO) Change per Day
|
-0.169 ms
Interval -0.25 to -0.089
|
-0.027 ms
Interval -0.069 to 0.015
|
-0.076 ms
Interval -0.126 to -0.026
|
-0.049 ms
Interval -0.098 to 0.0002
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness
Estimated Mean Normalized Stiffness (VS/EO) at Enrollment
|
1.219 unitless (%)
Interval 1.199 to 1.239
|
1.228 unitless (%)
Interval 1.211 to 1.245
|
1.212 unitless (%)
Interval 1.19 to 1.233
|
1.234 unitless (%)
Interval 1.215 to 1.253
|
|
Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness
Estimated Normalized Stiffness (VS/EO) Change per Day
|
0.0001 unitless (%)
Interval -0.0004 to 0.0005
|
-0.0002 unitless (%)
Interval -0.0004 to -0.000005
|
-0.00011 unitless (%)
Interval -0.00036 to 0.00015
|
-0.00017 unitless (%)
Interval -0.0042 to 0.00007
|
|
Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness
Estimated Mean Normalized Stiffness (SS+VS/EO) at Enrollment
|
1.381 unitless (%)
Interval 1.354 to 1.408
|
1.382 unitless (%)
Interval 1.362 to 1.402
|
1.373 unitless (%)
Interval 1.345 to 1.401
|
1.388 unitless (%)
Interval 1.365 to 1.41
|
|
Central Sensorimotor Integration (CSMI) Test: Normalized Stiffness
Estimated Normalized Stiffness (SS+VS/EO) Change per Day
|
0.0004 unitless (%)
Interval -0.00002 to 0.0008
|
-0.0004 unitless (%)
Interval -0.0005 to -0.0002
|
-0.000046 unitless (%)
Interval -0.0003 to 0.00021
|
-0.000030 unitless (%)
Interval -0.000055 to -0.000004
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Central Sensorimotor Integration (CSMI) Test: Normalized Damping
Estimated Mean Normalized Damping (VS/EO) at Enrollment
|
0.469 unitless (%)
Interval 0.458 to 0.48
|
0.469 unitless (%)
Interval 0.46 to 0.478
|
0.456 unitless (%)
Interval 0.445 to 0.466
|
0.479 unitless (%)
Interval 0.469 to 0.489
|
|
Central Sensorimotor Integration (CSMI) Test: Normalized Damping
Estimated Normalized Damping (VS/EO) Change per Day
|
0.0001 unitless (%)
Interval -0.0001 to 0.0003
|
-0.0001 unitless (%)
Interval -0.0002 to 0.00005
|
0.000050 unitless (%)
Interval -0.000086 to 0.000186
|
-0.00009 unitless (%)
Interval -0.00022 to 0.00004
|
|
Central Sensorimotor Integration (CSMI) Test: Normalized Damping
Estimated Mean Normalized Damping (SS+VS/EO) at Enrollment
|
0.491 unitless (%)
Interval 0.478 to 0.504
|
0.496 unitless (%)
Interval 0.485 to 0.507
|
0.485 unitless (%)
Interval 0.47 to 0.499
|
0.501 unitless (%)
Interval 0.49 to 0.513
|
|
Central Sensorimotor Integration (CSMI) Test: Normalized Damping
Estimated Normalized Damping (SS+VS/EO) Change per Day
|
0.0002 unitless (%)
Interval -0.00003 to 0.0005
|
-0.0002 unitless (%)
Interval -0.0003 to -0.00004
|
0.000015 unitless (%)
Interval -0.000014 to 0.000017
|
-0.000011 unitless (%)
Interval -0.000026 to 0.000004
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway
Estimated Evoked CoM Sway (SS+VS/EO) Change per Day
|
-0.001 deg
Interval -0.002 to -0.0003
|
0.0002 deg
Interval -0.0002 to 0.001
|
-0.00036 deg
Interval -0.00098 to 0.00026
|
-0.00049 deg
Interval -0.00066 to 0.00056
|
|
Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway
Estimated Mean Evoked CoM Sway (SS+VS/EO) at Enrollment
|
1.093 deg
Interval 1.027 to 1.159
|
1.068 deg
Interval 1.025 to 1.111
|
1.116 deg
Interval 1.047 to 1.184
|
1.050 deg
Interval 1.003 to 1.096
|
|
Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway
Estimated Mean Evoked CoM Sway (VS/EO) at Enrollment
|
0.289 deg
Interval 0.256 to 0.322
|
0.281 deg
Interval 0.253 to 0.309
|
0.308 deg
Interval 0.272 to 0.345
|
0.265 deg
Interval 0.236 to 0.294
|
|
Central Sensorimotor Integration (CSMI) Test: Evoked CoM Sway
Estimated Evoked CoM Sway (VS/EO) Change per Day
|
-0.004 deg
Interval -0.006 to -0.002
|
-0.0004 deg
Interval -0.001 to 0.001
|
-0.00029 deg
Interval -0.00068 to 0.00009
|
-0.00014 deg
Interval -0.00051 to 0.00023
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise
Estimated Mean Internal Sensory Noise (VS/EO) at Enrollment
|
0.088 deg
Interval 0.079 to 0.097
|
0.087 deg
Interval 0.079 to 0.095
|
0.092 deg
Interval 0.081 to 0.104
|
0.084 deg
Interval 0.076 to 0.091
|
|
Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise
Estimated Internal Sensory Noise (VS/EO) Change per Day
|
-0.003 deg
Interval -0.006 to -0.0004
|
0.0002 deg
Interval -0.001 to 0.002
|
0.000054 deg
Interval -0.00011 to 0.00022
|
-0.000051 deg
Interval -0.00021 to 0.0001
|
|
Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise
Estimated Mean Internal Sensory Noise (SS+VS/EO) at Enrollment
|
0.136 deg
Interval 0.125 to 0.147
|
0.126 deg
Interval 0.117 to 0.135
|
0.135 deg
Interval 0.123 to 0.147
|
0.127 deg
Interval 0.116 to 0.137
|
|
Central Sensorimotor Integration (CSMI) Test: Internal Sensory Noise
Estimated Internal Sensory Noise (SS+VS/EO) Change per Day
|
-0.003 deg
Interval -0.005 to -0.001
|
-0.0005 deg
Interval -0.001 to 0.001
|
0.0000097 deg
Interval -0.0000172 to 0.0000192
|
-0.00030 deg
Interval -0.00037 to -0.00027
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Post-concussion Symptom Scale From the Sport Concussion Assessment (SCAT) Tool Version 5
Estimated Mean at Enrollment
|
56.5 score on a scale
Interval 51.9 to 61.2
|
58.8 score on a scale
Interval 54.7 to 62.8
|
59.0 score on a scale
Interval 54.4 to 63.5
|
56.9 score on a scale
Interval 52.8 to 61.1
|
|
Post-concussion Symptom Scale From the Sport Concussion Assessment (SCAT) Tool Version 5
Estimated Change per Day
|
-0.349 score on a scale
Interval -0.398 to -0.3
|
-0.317 score on a scale
Interval -0.358 to -0.276
|
-0.361 score on a scale
Interval -0.414 to -0.308
|
-0.313 score on a scale
Interval -0.374 to -0.252
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Insomnia Severity Index (ISI)
Estimated Mean at Enrollment
|
14.0 score on a scale
Interval 12.7 to 15.3
|
16.1 score on a scale
Interval 15.0 to 17.2
|
15.5 score on a scale
Interval 14.2 to 16.8
|
15.0 score on a scale
Interval 13.9 to 16.2
|
|
Insomnia Severity Index (ISI)
Estimated Change per Day
|
-0.0725 score on a scale
Interval -0.0977 to -0.0473
|
-0.0590 score on a scale
Interval -0.0705 to -0.0474
|
-0.060 score on a scale
Interval -0.076 to -0.045
|
-0.059 score on a scale
Interval -0.073 to -0.044
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Earlier Physical Therapy
n=82 Participants
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.
|
Later Physical Therapy (Standard of Care)
n=121 Participants
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.
|
Physical Therapy With Home Monitoring
n=93 Participants
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 Participants
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Head Impact Test (HIT) - 6
Estimated Mean at Enrollment
|
61.7 score on a scale
Interval 60.3 to 63.2
|
62.5 score on a scale
Interval 61.4 to 63.7
|
62.4 score on a scale
Interval 61.0 to 63.8
|
62.0 score on a scale
Interval 60.8 to 63.2
|
|
Head Impact Test (HIT) - 6
Estimated Change per Day
|
-0.123 score on a scale
Interval -0.156 to -0.0885
|
-0.0819 score on a scale
Interval -0.0975 to -0.0663
|
-0.110 score on a scale
Interval -0.13 to -0.09
|
-0.076 score on a scale
Interval -0.096 to -0.056
|
Adverse Events
Earlier Physical Therapy
Later Physical Therapy (Standard of Care)
Physical Therapy With Home Monitoring
Physical Therapy (Without Home Monitoring)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Earlier Physical Therapy
n=82 participants at risk
Within a week of enrollment and baseline testing, participants (n=80) 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.
Timing 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.
|
Later Physical Therapy (Standard of Care)
n=121 participants at risk
Participants (n=80) 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.
Timing 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.
|
Physical Therapy With Home Monitoring
n=93 participants at risk
Participants started physical therapy after baseline testing and used wearable sensors during home exercises. Feedback was provided later at the next physical therapy session.
|
Physical Therapy (Without Home Monitoring)
n=110 participants at risk
Participants started physical therapy after baseline testing and did not use wearable sensors during home exercises. No feedback of performance was provided.
|
|---|---|---|---|---|
|
Vascular disorders
Medical Event: Nose bleed
|
1.2%
1/82 • Number of events 1 • Study duration (week 0 to week 14)
|
0.00%
0/121 • Study duration (week 0 to week 14)
|
0.00%
0/93 • Study duration (week 0 to week 14)
|
0.91%
1/110 • Number of events 1 • Study duration (week 0 to week 14)
|
|
Eye disorders
Medical Event: Swelling of Eye
|
1.2%
1/82 • Number of events 1 • Study duration (week 0 to week 14)
|
0.00%
0/121 • Study duration (week 0 to week 14)
|
1.1%
1/93 • Number of events 1 • Study duration (week 0 to week 14)
|
0.00%
0/110 • Study duration (week 0 to week 14)
|
|
Musculoskeletal and connective tissue disorders
Discomfort While Testing
|
1.2%
1/82 • Number of events 1 • Study duration (week 0 to week 14)
|
0.00%
0/121 • Study duration (week 0 to week 14)
|
1.1%
1/93 • Number of events 1 • Study duration (week 0 to week 14)
|
0.00%
0/110 • Study duration (week 0 to week 14)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place