Brain ConcussionPraxisNCT06314464
Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI
A study testing Praxis and Supervised cardiovascular exercise in people with Brain Concussion and Vestibular Disorder, run by BlueHalo at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Brain Concussion, Vestibular Disorder, Cognition Disorder
- What is being tested?
- Praxis and Supervised cardiovascular exercise
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participating in the SPaR Program
- 18-50 years old
- Have a self-reported or clinician-confirmed mTBI
- Have continued complaints of dizziness/imbalance
- Are right-handed as determined by the Edinburgh Handedness Inventory-Short Form
- Participating in the SPaR Program
- 18-50 years old
- No complaints of dizziness/imbalance
Who cannot join
- Having impaired mental capacity (e.g., altered capacity due to administration of any mind-altering substances or stress/life situations)
- Displaying behavior that would significantly interfere with validity of data collection or safety during the study
- Reporting significant pain during the evaluation (7/10 by patient subjective report)
- Being pregnant (balance considerations)
- Being unable to abstain from the use of alcohol and medications that might impair participant's balance or cerebral blood flow for 24 hours in advance of testing
- Being mixed or left-handed as determined by the Edinburgh Handedness Inventory-Short Form for the Praxis group undergoing rs-fMRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies for Post-TBI Return-to-duty (RTD) Decision Making (Praxis)
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:
Read more
- Can the Praxis testbed provide feasible/acceptable 4-week multisensory rehabilitation for SMs with post-acute mTBI?
- Can Praxis detect and influence measurable changes in readiness performance during mTBI recovery?
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:
- gaze stabilization
- dual-task balance training
- spatial navigation
- agility training
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.
Read the detailed description
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:
- deliver a well-defined rehabilitation strategy via the Praxis system to the enable the patient to practice challenging rehabilitation tasks,
- assess changes in neurophysiological activity via resting state functional magnetic resonance imaging (rs-fMRI) over time in relation to the intensity of the rehabilitation strategy, and
- assess sensitive behavioral outcome measures that monitor the SM's functional gains over time via a battery of military-relevant tasks.
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:
- gaze stabilization
- dual-task balance training
- spatial navigation
- agility training
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.
- Being tested
- Praxis, Supervised cardiovascular exercise
- Keywords
- Traumatic Brain Injury, Concussion, Dizziness, Vestibular Rehabilitation
- Medical subject headings
- Brain Concussion, Vestibular Diseases, Cognition Disorders, Brain Injuries, Traumatic, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PraxisDevice
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.
Supervised cardiovascular exerciseBehavioural
The supervised cardiovascular exercise does not incorporate gaze stabilization exercises (vestibulo-ocular reflex exercises) or smooth pursuit, saccade, agility, and dual tasking exercises.
| Study group | Role | What they receive |
|---|---|---|
| Praxis | Experimental | 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) Receives: Device: Praxis |
| Control | Active comparator | 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) Receives: Behavioral: Supervised cardiovascular exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Subjects will be tested after a 4-week intervention period
Secondary outcomes (14)
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%)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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%)
Measured: Acquired every 24 hours during the 4-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start12 Feb 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BlueHalo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Brooke Army Medical Center, University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Pedram Hovareshti, PhD, Principal investigator, BlueHalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314464
- Sponsor's protocol ID
- C2023.055
- Acronym
- Praxis
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hovareshti P, Roeder S, Holt LS, Gao P, Xiao L, Zalkin C, Ou V, Tolani D, Klatt BN, Whitney SL. VestAid: A Tablet-Based Technology for Objective Exercise Monitoring in Vestibular Rehabilitation. Sensors (Basel). 2021 Dec 15;21(24):8388. doi: 10.3390/s21248388.
PubMed 34960480Hoppes CW, Lambert KH, Whitney SL, Erbele ID, Esquivel CR, Yuan TT. Leveraging Technology for Vestibular Assessment and Rehabilitation in the Operational Environment: A Scoping Review. Bioengineering (Basel). 2024 Jan 25;11(2):117. doi: 10.3390/bioengineering11020117.
PubMed 38391603Whitney SL, Ou V, Hovareshti P, Costa CM, Cassidy AR, Dunlap PM, Roeder S, Holt L, Tolani D, Klatt BN, Hoppes CW. Utility of VestAid to Detect Eye-Gaze Accuracy in a Participant Exposed to Directed Energy. Mil Med. 2023 Jul 22;188(7-8):e1795-e1801. doi: 10.1093/milmed/usac294.
PubMed 36208334Alroumi AM, Hoppes CW, Whitney SL, Li Z, Holt L, Ramakrishnan S, Barnicott SL, Logeais MT, Richard H, Salter SR, Tiede JM, Wirt MD, Hovareshti P. A virtual reality system for delivery of military-specific vestibular rehabilitation after mild traumatic brain injury: the Praxis study protocol. Front Neurol. 2025 May 21;16:1558795. doi: 10.3389/fneur.2025.1558795. eCollection 2025.
PubMed 40470496
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies for Post-TBI Return-to-duty (RTD) Decision Making (Praxis)
- ClinicalTrials.gov ID
- NCT06314464
- Acronym / sponsor ID
- Praxis / C2023.055
- Keywords
- Traumatic Brain Injury, Concussion, Dizziness, Vestibular Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- BlueHaloIndustry (pharma, biotech, devices)
- Collaborators
- Brooke Army Medical Center, University of Pittsburgh
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can the Praxis testbed provide feasible/acceptable 4-week multisensory rehabilitation for SMs with post-acute mTBI?
- Can Praxis detect and influence measurable changes in readiness performance during mTBI recovery?
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:
- gaze stabilization
- dual-task balance training
- spatial navigation
- agility training
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.
Detailed description
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:
- deliver a well-defined rehabilitation strategy via the Praxis system to the enable the patient to practice challenging rehabilitation tasks,
- assess changes in neurophysiological activity via resting state functional magnetic resonance imaging (rs-fMRI) over time in relation to the intensity of the rehabilitation strategy, and
- assess sensitive behavioral outcome measures that monitor the SM's functional gains over time via a battery of military-relevant tasks.
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:
- gaze stabilization
- dual-task balance training
- spatial navigation
- agility training
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Praxis | Experimental | Device: PraxisFifteen 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) |
| Control | Active comparator | Behavioral: Supervised cardiovascular exerciseFifteen 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participating in the SPaR Program
- 18-50 years old
- Have a self-reported or clinician-confirmed mTBI
- Have continued complaints of dizziness/imbalance
- Are right-handed as determined by the Edinburgh Handedness Inventory-Short Form
Key exclusion criteria (6 listed)
- Having impaired mental capacity (e.g., altered capacity due to administration of any mind-altering substances or stress/life situations)
- Displaying behavior that would significantly interfere with validity of data collection or safety during the study
- Reporting significant pain during the evaluation (7/10 by patient subjective report)
- Being pregnant (balance considerations)
- Being unable to abstain from the use of alcohol and medications that might impair participant's balance or cerebral blood flow for 24 hours in advance of testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PraxisPraxis' 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. | Device | Praxis |
| Supervised cardiovascular exerciseThe supervised cardiovascular exercise does not incorporate gaze stabilization exercises (vestibulo-ocular reflex exercises) or smooth pursuit, saccade, agility, and dual tasking exercises. | Behavioural | Control |
Primary outcome
Perceived usability of the Praxis system measured by the System Usability Scale (SUS)
Time frame: Subjects will be tested after a 4-week intervention period
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.
14 secondary outcomes
Change in Dizziness Handicap Inventory (DHI) score
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in Pittsburgh Sleep Quality Index (PSQI) score
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in Generalized Anxiety Disorder scale (GAD-7) score
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
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in Vestibular Activities Avoidance Instrument-9 (VAAI-9) score
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in Headache Impact Test-6 (HIT-6) score
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in Santa Barbara Sense of Direction Scale (SBSOD) score
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)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in perceived fogginess
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
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)
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)
Time frame: Subjects will be tested before and after a 4-week intervention period
Change in Vestibular/Ocular Motor Screening (VOMS) total symptom score
Time frame: Subjects will be tested before and immediately after intervention
Compliance with 20-minute daily dose of gaze stability exercises
Time frame: Acquired every 24 hours during the 4-week intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Background: PubMed 34960480Hovareshti P, Roeder S, Holt LS, Gao P, Xiao L, Zalkin C, Ou V, Tolani D, Klatt BN, Whitney SL. VestAid: A Tablet-Based Technology for Objective Exercise Monitoring in Vestibular Rehabilitation. Sensors (Basel). 2021 Dec 15;21(24):8388. doi: 10.3390/s21248388.
- Background: PubMed 38391603Hoppes CW, Lambert KH, Whitney SL, Erbele ID, Esquivel CR, Yuan TT. Leveraging Technology for Vestibular Assessment and Rehabilitation in the Operational Environment: A Scoping Review. Bioengineering (Basel). 2024 Jan 25;11(2):117. doi: 10.3390/bioengineering11020117.
- Background: PubMed 36208334Whitney SL, Ou V, Hovareshti P, Costa CM, Cassidy AR, Dunlap PM, Roeder S, Holt L, Tolani D, Klatt BN, Hoppes CW. Utility of VestAid to Detect Eye-Gaze Accuracy in a Participant Exposed to Directed Energy. Mil Med. 2023 Jul 22;188(7-8):e1795-e1801. doi: 10.1093/milmed/usac294.
- Derived from this study: PubMed 40470496Alroumi AM, Hoppes CW, Whitney SL, Li Z, Holt L, Ramakrishnan S, Barnicott SL, Logeais MT, Richard H, Salter SR, Tiede JM, Wirt MD, Hovareshti P. A virtual reality system for delivery of military-specific vestibular rehabilitation after mild traumatic brain injury: the Praxis study protocol. Front Neurol. 2025 May 21;16:1558795. doi: 10.3389/fneur.2025.1558795. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedram Hovareshti, PhD principal investigator
BlueHalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Praxis and Supervised cardiovascular exercise in people with Brain Concussion and Vestibular Disorder, run by BlueHalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived usability of the Praxis system measured by the System Usability Scale (SUS) (time frame: Subjects will be tested after a 4-week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06314464, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.