Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes in mTBI?
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 8/24/2018 |
| Start Date: | July 15, 2018 |
| End Date: | May 1, 2021 |
Sensory Integration Balance Deficits in Complex mTBI: Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes?
Every year 1.7 million people sustain a traumatic brain injury (TBI) in the United States and
of these, 84 % are considered mild TBI (mTBI). mTBI is common both in civilian and military
populations and can be debilitating if symptoms do not resolve after injury. Balance problems
are one of the most common complaints after sustaining a mTBI and often prevent individuals
from returning to their previous quality of life. However, the investigators currently lack
clear guidelines on when to initiate physical therapy rehabilitation and it is unclear if
early physical therapy is beneficial. The investigators believe that the underlying problem
of imbalance results from damage to parts of the brain responsible for interpreting sensory
information for balance control. The investigators hypothesize that retraining the brain
early, as opposed to months after injury, to correctly interpret sensory information will
improve recovery. The investigators also believe this retraining is limited when
rehabilitation exercises are performed incorrectly, and that performance feedback from
wearable sensors, can improve balance rehabilitation. There are three objectives of this
study: 1) to determine how the timing of rehabilitation affects outcomes after mTBI; 2) to
determine if home monitoring of balance exercises using wearable sensors improves outcomes;
and 3) to develop a novel feedback system using wearable sensors to provide the physical
therapist information, in real-time during training, about quality of head and trunk
movements during prescribed exercises. The findings from this research could be very readily
adopted into military protocols for post-mTBI care and have the potential to produce better
balance rehabilitation and quality of life for mTBI patients and their families.
of these, 84 % are considered mild TBI (mTBI). mTBI is common both in civilian and military
populations and can be debilitating if symptoms do not resolve after injury. Balance problems
are one of the most common complaints after sustaining a mTBI and often prevent individuals
from returning to their previous quality of life. However, the investigators currently lack
clear guidelines on when to initiate physical therapy rehabilitation and it is unclear if
early physical therapy is beneficial. The investigators believe that the underlying problem
of imbalance results from damage to parts of the brain responsible for interpreting sensory
information for balance control. The investigators hypothesize that retraining the brain
early, as opposed to months after injury, to correctly interpret sensory information will
improve recovery. The investigators also believe this retraining is limited when
rehabilitation exercises are performed incorrectly, and that performance feedback from
wearable sensors, can improve balance rehabilitation. There are three objectives of this
study: 1) to determine how the timing of rehabilitation affects outcomes after mTBI; 2) to
determine if home monitoring of balance exercises using wearable sensors improves outcomes;
and 3) to develop a novel feedback system using wearable sensors to provide the physical
therapist information, in real-time during training, about quality of head and trunk
movements during prescribed exercises. The findings from this research could be very readily
adopted into military protocols for post-mTBI care and have the potential to produce better
balance rehabilitation and quality of life for mTBI patients and their families.
Although balance is one of the most common and debilitating complaints after mTBI, the
investigators currently lack clear guidelines on when to initiate balance rehabilitation and
it is unclear if early physical therapy is beneficial. There is a clear gap in clinical care
guidelines after mTBI and it is unclear if initiating rehabilitation early would improve
outcomes related to imbalance. Measures of imbalance are subjective and are easily overlooked
as a treatable deficit. Even with rehabilitation, recovery of balance in people with mTBI is
challenging, particularly in people with central vestibular and sensory integration deficits.
Although vestibular and balance rehabilitation after mTBI relies heavily on a home exercise
program and repetition is essential for recovery; The slow progress in balance rehabilitation
may be partially due to an inability of people with mTBI to correctly perform the prescribed
rehabilitation exercises on their own. Biofeedback is a clinical technique that provides
physiologic information that would otherwise be unknown to patients and may improve outcomes
after mTBI. There are no commercially available systems to provide the physical therapist
and/or patient objective information on the quality of head movements during training of
rehabilitation tasks that involve balance and walking.
Therefore, the three objectives of this study are: 1) to determine how the timing of
rehabilitation affects outcomes after mTBI; 2) to determine if home monitoring of balance
exercises using wearable sensors improves outcomes; and 3) to develop a novel feedback system
using wearable sensors to provide the physical therapist information, in real-time during
training, about quality of head and trunk movements during prescribed exercises.
160 individuals with acute mTBI within 12 weeks of the injury will be randomly assigned to
receive early onset of physical therapy (n=80) right away or be randomly assigned to receive
delayed rehabilitation by 3 months in the standard of care physical therapy group (n=80). A
subgroup of participants in the early physical therapy (n=40) and standard of care physical
therapy (n=40) will be randomly assigned to home monitoring. The participants will wear
wireless sensors while completing the rehabilitation program in order to better inform the
physiotherapist of their progress.
The outcome measures will consist of a battery of self-reported questionnaires, balance and
gait measures, as well as vestibular measures and will be tested at Pre I (baseline), Pre 2
(3 months later for the delayed rehabilitation group), Post (after the intervention), and
Retention (3 month follow-up).
The central hypothesis is that rehabilitation after mTBI is suboptimal due to late initiation
of and inadequate performance of exercises that do not adequately challenge vestibular and
sensory integration function. The long-term goal is to clarify best practices for the
rehabilitation of balance deficits in people with mTBI by comparing early vs late (standard
of care) initiation of physical therapy with and without wearable sensors on balance deficits
after mTBI. The findings from this research could be very readily adopted into military
protocols for post-mTBI care and have the potential to produce better balance rehabilitation
and quality of life for mTBI patients and their families.
investigators currently lack clear guidelines on when to initiate balance rehabilitation and
it is unclear if early physical therapy is beneficial. There is a clear gap in clinical care
guidelines after mTBI and it is unclear if initiating rehabilitation early would improve
outcomes related to imbalance. Measures of imbalance are subjective and are easily overlooked
as a treatable deficit. Even with rehabilitation, recovery of balance in people with mTBI is
challenging, particularly in people with central vestibular and sensory integration deficits.
Although vestibular and balance rehabilitation after mTBI relies heavily on a home exercise
program and repetition is essential for recovery; The slow progress in balance rehabilitation
may be partially due to an inability of people with mTBI to correctly perform the prescribed
rehabilitation exercises on their own. Biofeedback is a clinical technique that provides
physiologic information that would otherwise be unknown to patients and may improve outcomes
after mTBI. There are no commercially available systems to provide the physical therapist
and/or patient objective information on the quality of head movements during training of
rehabilitation tasks that involve balance and walking.
Therefore, the three objectives of this study are: 1) to determine how the timing of
rehabilitation affects outcomes after mTBI; 2) to determine if home monitoring of balance
exercises using wearable sensors improves outcomes; and 3) to develop a novel feedback system
using wearable sensors to provide the physical therapist information, in real-time during
training, about quality of head and trunk movements during prescribed exercises.
160 individuals with acute mTBI within 12 weeks of the injury will be randomly assigned to
receive early onset of physical therapy (n=80) right away or be randomly assigned to receive
delayed rehabilitation by 3 months in the standard of care physical therapy group (n=80). A
subgroup of participants in the early physical therapy (n=40) and standard of care physical
therapy (n=40) will be randomly assigned to home monitoring. The participants will wear
wireless sensors while completing the rehabilitation program in order to better inform the
physiotherapist of their progress.
The outcome measures will consist of a battery of self-reported questionnaires, balance and
gait measures, as well as vestibular measures and will be tested at Pre I (baseline), Pre 2
(3 months later for the delayed rehabilitation group), Post (after the intervention), and
Retention (3 month follow-up).
The central hypothesis is that rehabilitation after mTBI is suboptimal due to late initiation
of and inadequate performance of exercises that do not adequately challenge vestibular and
sensory integration function. The long-term goal is to clarify best practices for the
rehabilitation of balance deficits in people with mTBI by comparing early vs late (standard
of care) initiation of physical therapy with and without wearable sensors on balance deficits
after mTBI. The findings from this research could be very readily adopted into military
protocols for post-mTBI care and have the potential to produce better balance rehabilitation
and quality of life for mTBI patients and their families.
Inclusion Criteria:
- Inclusion criteria will consist of being 1) 18-60 years of age; 2) having minimal
cognitive impairment as assessed by the Short Blessed test; and 3) having either a
diagnosis of mild traumatic brain injury with persisting symptoms for less than or
equal to 12 weeks post-injury for the mild traumatic brain injury (mTBI) group, or no
history of mTBI or brain injury within the past year for the control group.
Exclusion Criteria:
- Exclusion criteria will consist of: 1) any other neurological illness or major surgery
causing balance deficits; 2) significant pain during testing; 3) pregnancy; 4) history
of balance complaints; 5) peripheral vestibular pathology other than from the mTBI; 6)
ocular-motor deficits prior to mTBI; 7) or an inability to abstain from medications
that influence balance. All participants will be asked to refrain from taking drugs
that may influence balance including sedating antihistamines, benzodiazepines,
sedatives, narcotic pain medications and alcohol for at least 24 hours prior to
testing.
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Phone: 503-418-2602
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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