Quality of Life Clinical Trial
Official title:
Sensory Integration Balance Deficits in Complex mTBI: Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes?
Verified date | May 2023 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 160 |
Est. completion date | September 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | United States Department of Defense |
United States,
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
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. — View Citation
Shepard NT, Telian SA. Programmatic vestibular rehabilitation. Otolaryngol Head Neck Surg. 1995 Jan;112(1):173-82. doi: 10.1016/S0194-59989570317-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sport Concussion Assessment Tool-2 | Screening form to describe brain injury | 5 min | |
Other | Insomnia Severity Index | Self-rated questionnaire 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 | 5 min | |
Other | Head Impact Test-6 | Self-rated questionnaire 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 | 5 min | |
Other | Buffalo Treadmill Test | Physical assessment to measure heart rate and symptom score (0: no symptoms; 10: severe symptoms) | 20 min | |
Primary | Dizziness Handicap Inventory | Self-rated questionnaire for dizziness impairment rated on a 3-point scale (0: no; 4: always) with a maximum score of 100 | 5 minutes | |
Secondary | Automated Neuropsychological Assessment Metrics | Computer-based test of cognition | 20 min | |
Secondary | Neurobehavioral Symptom Inventory | Self-rated questionnaire for symptom severity on a scale from 0 (none) to 4 (very severe) with a maximum score of 88 | 5 min | |
Secondary | Quality of Life After Brain Injury | Self-rated questionnaire for quality of life questioning satisfaction on a scale from 0 (not at all) to 4 (very) with a maximum score of 168 | 5 min | |
Secondary | Patient Global Impression of Change Scale | One question rated on a seven point Likert scale (1: no change or condition has gotten worse; 7: a great deal better and a considerable improvement that has made all the difference) | 1 min | |
Secondary | Walking | Physical assessment using wearable inertial sensors to quantify sway when walking at a self-selected pace with and without the auditory stroop | 2 min | |
Secondary | Complex Navigation Task | Physical assessment using wearable inertial sensors to quantify sway while negotiating a complex course. Participants will walk at a self-selected pace and fast pace and while performing the auditory stroop task (only during self-selected pace. | 20 min | |
Secondary | Central SensoriMotor Integration Test | Physical assessment to quantify sway response to pseudo-random stimuli to calculate sensory weighting and neural controller parameters | 45 min | |
Secondary | Auditory Processing | Physical assessment to quantify auditory processing using Spatial Release | 5 min | |
Secondary | Dynamic Visual Acuity | Physical assessment of vision during a Logarithm of the Minimum Angle of Resolution Chart reading, with higher scores indicating worse vision (range: -0.30-1.00) | 2 min | |
Secondary | Vestibular and ocular-motor test (VOMs)-instrumented | Physical assessment using eye tracking to assess function of the 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) | 10 min | |
Secondary | Mini-Balance Evaluation Systems Test | Physical assessment using wearable inertial sensors to quantify balance and clinically scored on a 3-point scale (0: severe; 2: normal) with a maximum score of 28 | 20 min | |
Secondary | Return to Activity Question | One question asking participants when they returned to regular daily activities | 1 min | |
Secondary | Modified Balance Error Scoring System (mBESS) | Physical assessment using wearable inertial sensors to quantify posture and clinically scored on a scale from 0-10 (0: no errors; 10: 10 or more errors) for each of the three conditions | 5 min |
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