Clinical trial NCT03479541: Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes in mTBI?
Official title: Sensory Integration Balance Deficits in Complex mTBI: Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Traumatic Brain Injury
Balance; Distorted
Gait, Unsteady
Quality of Life
Veterans
Keywords: mild traumatic brain injury
vestibular impairment
balance and gait
dual-tasking
veterans
quality of life
rehabilitation
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2018-03-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Every year 1.7 million people sustain a traumatic brain injury (TBI) in the United States and of these, 84 % are considered mild TBI (mTBI). mTBI is common both in civilian and military populations and can be debilitating if symptoms do not resolve after injury. Balance problems are one of the most common complaints after sustaining a mTBI and often prevent individuals from returning to their previous quality of life. However, the investigators currently lack clear guidelines on when to initiate physical therapy rehabilitation and it is unclear if early physical therapy is beneficial. The investigators believe that the underlying problem of imbalance results from damage to parts of the brain responsible for interpreting sensory information for balance control. The investigators hypothesize that retraining the brain early, as opposed to months after injury, to correctly interpret sensory information will improve recovery. The investigators also believe this retraining is limited when rehabilitation exercises are performed incorrectly, and that performance feedback from wearable sensors, can improve balance rehabilitation. There are three objectives of this study: 1) to determine how the timing of rehabilitation affects outcomes after mTBI; 2) to determine if home monitoring of balance exercises using wearable sensors improves outcomes; and 3) to develop a novel feedback system using wearable sensors to provide the physical therapist information, in real-time during training, about quality of head and trunk movements during prescribed exercises. The findings from this research could be very readily adopted into military protocols for post-mTBI care and have the potential to produce better balance rehabilitation and quality of life for mTBI patients and their families.

Detailed description: Although balance is one of the most common and debilitating complaints after mTBI, the investigators currently lack clear guidelines on when to initiate balance rehabilitation and it is unclear if early physical therapy is beneficial. There is a clear gap in clinical care guidelines after mTBI and it is unclear if initiating rehabilitation early would improve outcomes related to imbalance. Measures of imbalance are subjective and are easily overlooked as a treatable deficit. Even with rehabilitation, recovery of balance in people with mTBI is challenging, particularly in people with central vestibular and sensory integration deficits.

Although vestibular and balance rehabilitation after mTBI relies heavily on a home exercise program and repetition is essential for recovery; The slow progress in balance rehabilitation may be partially due to an inability of people with mTBI to correctly perform the prescribed rehabilitation exercises on their own. Biofeedback is a clinical technique that provides physiologic information that would otherwise be unknown to patients and may improve outcomes after mTBI. There are no commercially available systems to provide the physical therapist and/or patient objective information on the quality of head movements during training of rehabilitation tasks that involve balance and walking.

Therefore, the three objectives of this study are: 1) to determine how the timing of rehabilitation affects outcomes after mTBI; 2) to determine if home monitoring of 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, and balance and gait 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). Vestibular measures will occur at the baseline visit only.

The central hypothesis is that rehabilitation after mTBI is suboptimal due to late initiation of and inadequate performance of exercises that do not adequately challenge vestibular and sensory integration function. The long-term goal is to clarify best practices for the rehabilitation of balance deficits in people with mTBI by comparing 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dizziness Handicap Inventory
timeFrame: 5 minutes
Secondary outcomes:
measure: Automated Neuropsychological Assessment Metrics
timeFrame: 20 min
measure: Neurobehavioral Symptom Inventory
timeFrame: 5 min
measure: Quality of Life After Brain Injury
timeFrame: 5 min
measure: Patient Global Impression of Change Scale
timeFrame: 1 min
measure: Walking
timeFrame: 2 min
measure: Complex Navigation Task
timeFrame: 20 min
measure: Central SensoriMotor Integration Test
timeFrame: 45 min
measure: Auditory Processing
timeFrame: 5 min
measure: Dynamic Visual Acuity
timeFrame: 2 min
measure: Vestibular and ocular-motor test (VOMs)-instrumented
timeFrame: 10 min
measure: Mini-Balance Evaluation Systems Test
timeFrame: 20 min
measure: Return to Activity Question
timeFrame: 1 min
measure: Modified Balance Error Scoring System (mBESS)
timeFrame: 5 min
Other outcomes:
measure: Sport Concussion Assessment Tool-2
timeFrame: 5 min
measure: Insomnia Severity Index
timeFrame: 5 min
measure: Head Impact Test-6
timeFrame: 5 min
measure: Buffalo Treadmill Test
timeFrame: 20 min
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
citation: Faul, M., Xu, L., Wald, M. M., & Coronado, V.G. (2010). Traumatic brain injury in the United States: Emergency Department Visits, Hospitalizations and Deaths 2002-2006. Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control. https://www.cdc.gov/traumaticbraininjury/pdf/blue_book.pdf
citation: Pfaltz CR, Kamath R. Central compensation of vestibular dysfunction. I. Peripheral lesions. Pract Otorhinolaryngol (Basel). 1970;32(6):335-49. doi: 10.1159/000274957. No abstract available.
citation: Shepard NT, Telian SA. Programmatic vestibular rehabilitation. Otolaryngol Head Neck Surg. 1995 Jan;112(1):173-82. doi: 10.1016/S0194-59989570317-9.
citation: Parrington L, Jehu DA, Fino PC, Stuart S, Wilhelm J, Pettigrew N, Murchison CF, El-Gohary M, VanDerwalker J, Pearson S, Hullar T, Chesnutt JC, Peterka RJ, Horak FB, King LA. The Sensor Technology and Rehabilitative Timing (START) Protocol: A Randomized Controlled Trial for the Rehabilitation of Mild Traumatic Brain Injury. Phys Ther. 2020 Apr 17;100(4):687-697. doi: 10.1093/ptj/pzaa007.