An interventional study of Praxis and Supervised cardiovascular exercise in Brain Concussion, Vestibular Disorder and Cognition Disorder, sponsored by BlueHalo. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by BlueHalo · Not applicable, Interventional, and Device feasibility
The goal of this comparative pilot study is to provide evidence that Praxis, a portable testbed with low-cost wearable sensors and a mixed reality environment, can deliver effective multisensory rehabilitation exercises with military face-validity in a military service member (SM) population after mild Traumatic Brain Injury (mTBI).
The main questions this comparative pilot study aims to answer are:
Fifteen SMs with post-acute mTBI from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will participate in the multisensory vestibular rehabilitation regimen. These SMs will go through 4 weeks of multisensory vestibular rehabilitation including:
Data from another fifteen SMs, who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise, will be used as the control group.
Researchers will compare the Praxis and Control group to determine if the Praxis group shows improvement over the control group with respect to the military-relevant behavioral performance outcomes and patient-reported symptom scores after the end of the rehabilitation.
This study considers Praxis: a portable testbed with low-cost wearable sensors and a mixed reality environment to deliver effective multisensory rehabilitation exercises with military face-validity. Through a small comparative pilot study, the investigators plan to provide evidence for future multi-center randomized trials (MCRTs) to show that progress in these multisensory exercises correlates with established military readiness assessments; and that the improvements in functional performance in response to multisensory rehabilitation strategies is associated with changes in brain activity.
In preparation for an MCRT, the investigators will conduct a pilot study to examine and settle the issues of feasibility and effectiveness of protocol implementation in accordance with best practices. In this study, we:
Fifteen SMs with post-acute mTBI from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will participate in the multisensory vestibular rehabilitation regimen. These SMs will go through 4 weeks of multisensory vestibular rehabilitation:
Data from another fifteen SMs, who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise, will be used as the control group.
The first purposes of this study are to demonstrate the feasibility of obtaining a representative sample of SMs with and without vestibular/ocular impairments post-mTBI in a Special Operations population; determine whether the data is collected reliably; and establish compliance with the protocol in the 4-week study timeline. The primary endpoints for this study are feasibility/acceptability of the 4-week multisensory rehabilitation for SMs with post-acute mTBI as determined by compliance to daily rehabilitation doses as verified by the VestAid software and acceptability measured by the System Usability Scale (SUS) with success thresholds set at 80% or more of the target population completing all the doses and an average total score of 68 or above on the SUS assessment.
The second purpose of this study is to determine the average values and variations of the behavioral outcome measures before and after multisensory rehabilitation delivered by Praxis, as well as the changes in neurophysiological activity, and the correlation between the two. The investigators will use this information to determine the sample size required for a future, larger multicenter study.
The investigators aim to evaluate the effect size relating the implicated functional changes to recovery over the 4-week rehabilitation period in the military population under study. The secondary endpoints of this pilot study will comprise preliminary statistical insights into the ability of Praxis to detect and influence measurable changes in readiness performance during mTBI recovery. The collected metrics include longitudinal Praxis compliance score, pre- and post- behavioral outcome measurements from the readiness battery, and patient-perceived disability questionnaires. Between-group analyses will be conducted to determine the effect size of the Praxis protocol on both the military-relevant behavioral outcomes as well as the patient-reported symptom scores. Within the Praxis group, the investigators will perform an exploratory analysis to examine the correlations between the military-relevant behavioral outcome scores, Praxis compliance scores, and previously implicated objective neurophysiological measures.
172 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.
This study's planned enrollment of 30 is below the median of 44 across 130 interventional studies indexed under Vestibular Diseases.
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Inclusion Criteria for Praxis Group:
Inclusion Criteria for Control Group:
Exclusion Criteria:
Fifteen SMs with post-acute mTBI and residual dizziness/imbalance complaints from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will receive 4 weeks of Praxis intervention (45 minutes, 5 days per week)
Device: Praxis
Fifteen SMs without dizziness/imbalance complaints from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will receive 4 weeks of supervised cardiovascular activity (45 minutes, 5 days per week)
Behavioral: Supervised cardiovascular exercise
Praxis' gaze stabilization exercises are delivered via the tablet-based VestAid software that uses the tablet camera to automatically assess compliance in the conduct of vestibulo-ocular reflex exercises. The smooth pursuit, saccade, agility, and dual tasking exercises are delivered in the form of military-themed mixed reality games using the HTC Vive Focus 3 headset.
The supervised cardiovascular exercise does not incorporate gaze stabilization exercises (vestibulo-ocular reflex exercises) or smooth pursuit, saccade, agility, and dual tasking exercises.
Perceived usability of the Praxis system measured by the System Usability Scale (SUS)
The System Usability Scale (SUS) provides an industry-standard reliable tool for measuring the usability of a system (unit of measurement: number, 0-100). This scale relates to the usability (e.g., feasibility) of the prototype device, and is not a health outcome.
Time frame: Subjects will be tested after a 4-week intervention period
Change in Dizziness Handicap Inventory (DHI) score
The Dizziness Handicap Inventory (DHI) is a 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness (unit of measurement: percentage, 0-100%)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in Pittsburgh Sleep Quality Index (PSQI) score
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over the study time interval (unit of measurement: number, 0-21)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in Generalized Anxiety Disorder scale (GAD-7) score
The Generalized Anxiety Disorder scale (GAD-7) is a self-administered patient questionnaire used as a screening tool and severity measure for generalized anxiety disorder (GAD) (unit of measurement: number, 0-21)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in Post-Traumatic Stress Disorder Check List - Military Version (PCL-M) score
The Post-Traumatic Stress Disorder Check List - Military Version (PCL-M) assesses the presence and severity of PTSD symptoms as defined by the Diagnostic and Statistical Manual of Mental Disorders in military personnel (unit of measurement: number, 17-85)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in Vestibular Activities Avoidance Instrument-9 (VAAI-9) score
The Vestibular Activities Avoidance Instrument-9 (VAAI-9) is a patient-reported outcome measure developed to identify fear avoidance beliefs in persons with vestibular disorders (unit of measurement: number, 0-54)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in Headache Impact Test-6 (HIT-6) score
The Headache Impact Test-6 (HIT-6) was developed to measure a wide spectrum of the factors contributing to the burden of headache, and the HIT-6 has demonstrated utility for generating quantitative and pertinent information on the impact of headache. The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress (unit of measurement: number, 36-78)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in Santa Barbara Sense of Direction Scale (SBSOD) score
The Santa Barbara Sense of Direction Scale (SBSOD) is a standardized self-report scale of environmental spatial ability (unit of measurement: number, 1-7; the average of the 15 items)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in time required to perform 300-yard shuttle run (single- and dual-task)
The 300-yard shuttle run is part of the Ranger Athlete Warrior assessments, and is used to measure anaerobic endurance. The 8-digit grid coordinate memorization task employed in the ReTURN study protocol has been added to provide a cognitive dual-task (unit of measurement: seconds)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in perceived fogginess
Fogginess will be assessed by asking the subject to rate this symptom on a scale from 0 to 10 (as instructed in the Vestibular/Ocular Motor Screening \[VOMS\], incorporated into the Military Acute Concussion Evaluation 2). (unit of measurement: number, 0-10)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in time required to perform 5-10-5 shuttle run
The 5-10-5 shuttle run is part of the Ranger Athlete Warrior assessments, and is used to measure change in direction / agility. (unit of measurement: seconds)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in score for 4-Item Hybrid Assessment of Mobility for mTBI (HAM-4-mTBI)
The 4-Item Hybrid Assessment of Mobility for mTBI (HAM-4-mTBI) incorporates Functional Gait Assessment's Gait with Horizontal Head Turns and with Pivot Turn, and High Level Mobility Assessment Tool's Fast Forward and Backward Walk (unit of measurement: number, 0-14)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in time required to perform POrtable WARrior Test Of Tactical AgiLity (POWAR-TOTAL) (single- and dual-task)
The POrtable WARrior Test Of Tactical AgiLity (POWAR-TOTAL) is a military-relevant assessment of agility (unit of measurement: seconds)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in Vestibular/Ocular Motor Screening (VOMS) total symptom score
The Vestibular/Ocular Motor Screening (VOMS) total symptom score will be acquired using the Praxis system and include headache, dizziness, nausea, fogginess symptoms scores (unit of measurement: number, 0-40; the sum of the 4 items)
Time frame: Subjects will be tested before and immediately after intervention
Compliance with 20-minute daily dose of gaze stability exercises
The compliance with 20-minute daily dose of gaze stability exercises will be acquired using the VestAid system and include the percentage of time (X minutes out of 20 minutes per day) that the subject performed assigned exercises (unit of measurement: percentage, 0-100%)
Time frame: Acquired every 24 hours during the 4-week intervention period
Plan to share: No
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