Randomized Controlled Trial for Vestibular Treatment in Concussion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 121
- Locations
- 4
- Primary Endpoint
- Dizziness Handicap Inventory (DHI)
Study Overview
Brief Summary
A prospective, single-blind, four-group multi-center randomized controlled trial (RCT) of targeted rehabilitation exercises for vestibular symptoms and impairments (T-REV) in civilians with mild traumatic brain injury (mTBI) will be conducted at the University of Pittsburgh Medical Center Sports Medicine Concussion Program (UPitt). The four treatment groups will consist of the factorial combinations of low (30%) and high (70%) intensity of exercise crossed with low (12-18 min, 1x/day) and high (12-18 min, 2x/day) frequency. A total of 125 participants aged 18-50 years will be enrolled across years 1-4, with approximately 100 participants completing the whole study. After potential participants with mTBI are screened for the vestibular clinical profile, using domain-specific tests and measures, and enrolled into the study, participants will complete primary and secondary outcome measures and receive a home exercise program that a) targets participants individual deficits, and b) is of the appropriate intensity and frequency for the participant's randomly assigned treatment group. Participants will return for in-clinic visits once per week to receive treatment and progress assigned exercises.
Detailed Description
During the past 17 years, US military personnel experienced 305,000 mTBI (DVBIC, 2017), with an estimated 65% (187,000) involving some type of vestibular impairment (gaze, postural/dynamic instability) and symptoms (dizziness, vertigo, motion intolerance) (Mucha et al., 2014). These vestibular impairments and symptoms, which have been associated with poor outcomes following mTBI including longer recovery times (Lau et al., 2011), can be actively treated using targeted vestibular rehabilitation exercises (Alsalaheen et al., 2010). In fact, the investigators recently concluded an observational trial of military personnel and civilians with mTBI- Targeted Evaluation, Action and Monitoring of TBI (TEAM-TBI) project (W81XWH-14-2-0002) supporting the effectiveness of targeted vestibular rehabilitation exercises in military personnel and civilians with complex mTBI (Kontos et al., in press). Although these vestibular-focused rehabilitation exercises are commonly used by military medical personnel following complex mTBI, there are no well-designed studies that show how much these exercises should be performed to be effective in US military personnel. In short, the concussion rehabilitation field does not know how frequently or intensely the exercises should be performed in order for injured personnel to have the best recovery.
In the current proposal, the investigators leverage our interdisciplinary team of experts from physical therapy, neurology, neuropsychology, and sports medicine and over 17 years of clinical and research experience to conduct a RCT comparing different frequency and intensity of targeted vestibular therapeutic exercises in military personnel and civilians. In so doing, the proposed study may inform a more precise approach for treating vestibular symptoms and impairments following mTBI that minimizes morbidity and accelerates recovery. Deliverables from the current study include: 1) outcome data regarding the efficacy of different frequencies and intensities of targeted vestibular exercises in both military personnel and civilians, and 2) evidence-based clinical practice guidelines (CPG) for prescribing vestibular therapeutic exercises.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-50 years of age
- •Normal/corrected vision
- •Diagnosed with sport-related mTBI/concussion in the past 8 days-1 year with clear mechanism of injury
- •Glasgow coma scale (GCS) of 13 or greater
- •Reported signs of mTBI including: loss of consciousness, amnesia, disorientation, confusion, dizziness, imbalance, memory problems, vomiting
- •mTBI-related vestibular symptoms (dizziness, vertigo, motion intolerance) and/or impairments (gaze stabilization, standing balance, functional gait) per a comprehensive assessment, clinical exam, and interview
Exclusion Criteria
- •History of vestibular disorder prior to current mTBI (benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction)
- •Benign Paroxysmal Positional Vertigo (BPPV) resulting from vestibular hypofunction
- •Dizziness symptoms that only result from exercise
- •History of neurological disorder
- •<1 month or >6 months following current mTBI
- •Currently pregnant or become pregnant during study
- •Currently involved in litigation associated with current or previous mTBI Note: history of motion sickness/sensitivity will NOT be excluded. We will adjust for any imbalance in groups on this factor by covariate analysis
Arms & Interventions
Low Intensity/Low Frequency
Participants will be assigned T-REV with low intensity (30% of perceived effort) and low frequency (exercises performed 1x/day)
Intervention: T-REV (Behavioral)
Low Intensity/ High Frequency
Participants will be assigned T-REV with low intensity (30% of perceived effort) and high frequency (exercises performed 2x/day)
Intervention: T-REV (Behavioral)
High Intensity/Low Frequency
Participants will be assigned T-REV with high intensity (70% of perceived effort) and low frequency (exercises performed 1x/day)
Intervention: T-REV (Behavioral)
High Intensity/High Frequency
Participants will be assigned T-REV with high intensity (70% of perceived effort) and high frequency (exercises performed 2x/day)
Intervention: T-REV (Behavioral)
Outcomes
Primary Outcomes
Dizziness Handicap Inventory (DHI)
Time Frame: enrollment, 2-week, 4-week, 3-month study visits
The DHI is a 25-item self-report measure that examines dizziness-related handicap. Each item is categorized into one of three domains: functional, emotional, or physical. The DHI was developed with the help of patients who complained of dizziness and uses a three-item response scale (Yes, Sometimes, No) scored as 4/2/0, respectively. Score range: 0-100. The DHI has good internal consistency for the total score (alpha = 0.89). the test-retest reliability is high (r=0.97) and is response to change in a vestibular population. The DHI has been demonstrated to be valid in individuals with mTBI. The outcome measure will be assessed at multiple timepoints to assess change over time.
Secondary Outcomes
- Behavioral Symptom Inventory-18 (BSI-18)(enrollment, 2-week, 4-week study visits)
- Pittsburgh Sleep Quality Index (PSQI)(enrollment, 2-week, 4-week study visits)
- Identify (ID) Migraine(enrollment, 2-week, 4-week study visits)
- Patient Global Impression of Change (PGIC)(enrollment, 2-week, 4-week, 3-month study visits)
- Neurobehavioral Symptom Inventory (NSI)(enrollment, 2-week, 4-week, 3-month study visits)
- Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)(enrollment, 2-week, 4-week study visits)
- Neck Pain Numerical Rating Scale (Neck Pain NRS)(enrollment, 2-wk, 4-wk study visits)
- Return to Activity (RTA)(4-week, 3-month study visits)
- Visual Vertigo Analog Scale (VVAS)(2-week, 4-week study visits)
- Modified Balance Error Scoring System (mBESS)(2-week, 4-week study visits)
- Functional Gait Assessment (FGA)(enrollment, 2-week, 4-week study visits)
- High Level Mobility Assessment Tool (HiMAT)(enrollment, 2-week, 4-week study visits)
- Dizziness Numerical Rating Scale (Dizziness NRS)(enrollment, 2-wk, 4-wk study visits)
- International Physical Activity Questionnaire (IPAQ)(enrollment, 2-week, 4-week study visits)
- Vestibular Ocular Motor Screening (VOMS)(2-wk, 4-wk study visits)
Investigators
Anthony P. Kontos, Ph.D.
Associate Professor
University of Pittsburgh