MTBI - Mild Traumatic Brain InjuryVR4VPTNCT05326100
Use of Virtual and Augmented Reality Devices in Vestibular Physical Therapy for mTBI
A study testing Conventional Therapy (CPT), CAREN Therapy and Augmented Reality (AR) Therapy in people with MTBI - Mild Traumatic Brain Injury and Dysfunction of Vestibular System, run by Naval Health Research Center at 3 sites in United States.
Trial summary
Rapidly evolving virtual reality (VR) and augmented reality (AR) technologies are being incorporated by many large-scale industries, and the medical field is no exception. One area that has gained significant attention in recent years is virtual rehabilitation which allows physical therapists to leverage… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- MTBI - Mild Traumatic Brain Injury, Dysfunction of Vestibular System
- What is being tested?
- Conventional Therapy (CPT), CAREN Therapy and Augmented Reality (AR) Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2023to Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, active duty SMs between 18 and 65 years of age and enrolled in Defense Enrollment Eligibility Reporting System (DEERS)
- History of mTBI based on the Ohio State University Traumatic Brain Injury Identification (OSU TBI-ID)
- Require vestibular physical therapy as determined by a PT
- Normal or corrected vision based on the Snellen Eye Chart of at least 20/40
- Able to consistently follow verbal and written instructions and observe safety precautions
- Able to tolerate up to 60 minutes of physical therapy exercise, with breaks
Show all 9Show fewer
- Able to ambulate with contact guard assistance or less, and to walk unassisted over ground or on a treadmill for 10 minutes at a time
- Able to tolerate wearing a full body safety harness
- Able to tolerate wearing a head mounted display weighing up to 3 pounds for up to 60 minutes
Who cannot join
- History of a moderate or severe TBI (OSU TBI-ID; or DVBIC TBI Screening Tool)
- Under care of a physician for a neurodegenerative diagnosis
- History of seizures or syncope
- Clinical determination of Benign Paroxysmal Positional Vertigo (BPPV)
- Diagnosis of any of the following visual impairments: field cuts, macular degeneration, retinal detachment, diplopia, limited peripheral or central vision, or require prism lenses
- Unable or unwilling to use contacts for corrected vision
Show all 11Show fewer
- Require a medical device that can be affected by radio waves such as a pacemaker, defibrillator, or hearing devices (implantable or air conduction)
- Medications with significant sedating side effects that could impact safety (i.e., Phenobarbital, Ativan, etc.)
- Women who are more than 4 months pregnant may not participate in this study due to the effects advanced pregnancy can have on balance and vision. Note: Women who choose to participate will be informed up front that there are risks associated with pregnancy including decrements in postural control and falls. Additionally, changes in hormones, metabolism, fluid retention, and blood circulation during pregnancy can affect the eyes and eyesight. Women who become pregnant during the intervention should inform their PT immediately to determine if continued participation is possible.
- Concurrent participation, either clinically and/or as a part of another research study, in vestibular physical therapy and/or PTSD treatment
- Unable to consent for any reason
Trial locations and contacts
3 sites in 1 country.
Kerry Rosen, PhD contact
United States3 sites, 3 recruiting
- Recruiting
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, 20889
Sarah E Kruger, MS, 301-319-3722, sarah.e.kruger.civ@health.mil
Sarah E Kruger, MS
- Recruiting
Naval Health Research Center
San Diego, California, 92106
Pinata H Sessoms, PhD, pinata.h.sessoms.civ@health.mil
Jacob Vandehy, MS, jacob.a.vandehy.ctr@health.mil
- Recruiting
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Rapidly evolving virtual reality (VR) and augmented reality (AR) technologies are being incorporated by many large-scale industries, and the medical field is no exception. One area that has gained significant attention in recent years is virtual rehabilitation which allows physical therapists to leverage state-of-the-art immersive virtual environments to uniquely address functional deficits in patients who are unresponsive to conventional treatment techniques. Advanced VR and AR technologies are now available in commercially available small-scale, mobile head-mounted displays which can be readily used in outpatient clinic settings and possibly at home.
The aim of this study is to determine whether advanced VR- and AR-based physical therapy improves functional status and reduces self-reported symptoms in individuals experiencing vestibular disorders secondary to mild traumatic brain injury (mTBI). Study participants will be randomized into treatment groups: 1) conventional therapy, 2) therapy performed using a large-scale VR system (the Computer Assisted Rehabilitation Environment or CAREN), 3) therapy performed using a mobile AR. Upon completion of treatment, groups will be compared to determine functional outcome improvements with respect to static and dynamic balance as well as reduction of vestibular symptoms.
Read the detailed description
This protocol represents Phase 2 of a project that seeks to implement mobile AR-based technologies into vestibular physical therapy. The Phase 1 protocol (EIRB Number - NHRC.2019.0002) is ongoing and will compare outcomes from the AR-based HMD system (e.g., Magic Leap One) to the VR-based CAREN system. With validated instruments from Phase 1, this pilot prospective, three-armed randomized, interventional clinical trial seeks to incorporate advanced VR- and AR-based technologies as modalities in physical therapy for servicemembers (SMs) with mTBI who also experience vestibular dysfunction. The three arms are: 1) conventional vestibular physical therapy only (CPT), 2) CAREN only (CAREN), and 3) AR HMD only (AR).
Primary:
To determine whether advanced VR- and AR-based therapy, improves functional status and reduces self- reported symptoms in SMs with vestibular dysfunction and a history of mTBI.
Hypothesis: The investigators hypothesize that after completion of vestibular physical therapy, participants in the CAREN and AR groups will have better outcomes than those in the CPT group. In the CAREN and AR groups, the investigators anticipate greater improvements in static and dynamic balance, as measured by the Sensory Organization Test (SOT), Community Balance and Mobility Scale (CB\&M), and Functional Gait Assessment (FGA), as well as decreased vestibular symptoms, as measured by the Dizziness Handicap Inventory (DHI) and Activity-Specific Balance Confidence Scale (ABC).
Secondary:
To determine whether participants in the advanced technology groups demonstrate similar clinical improvements following treatment.
Hypothesis: The investigators hypothesize that after completion of vestibular physical therapy, participants in the CAREN and AR groups will show similar improvements in static and dynamic balance as well as vestibular symptoms; essentially, the investigators believe the VR- and AR-based therapies will be comparable.
Tertiary:
To investigate the user experience associated with utilizing advanced technology for the treatment of vestibular dysfunction.
Hypothesis: The investigators hypothesize that participants in the AR group will have greater satisfaction than the CAREN group, as measured by higher scores on the User Satisfaction Evaluation Questionnaire (USEQ).
Exploratory:
Efforts from this study seek to gather information to justify further implementation of AR-based therapy (using HMDs) as well as the development and incorporation of additional military-relevant tasks, such as return-to-duty tasks and measures to be developed for future research efforts.
- Being tested
- Conventional Therapy (CPT), CAREN Therapy, Augmented Reality (AR) Therapy
- Keywords
- Virtual Reality, Augmented Reality, Vestibular Physical Therapy, Computer Assisted Rehabilitation Environment (CAREN), Head Mounted Display (HMD), Physical Therapy, MTBI, Servicemember, Vestibular Dysfunction
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Therapy (CPT)Other
The exercises may include traditional vestibulo-ocular reflex (VOR) exercises, cervical musculoskeletal exercises, somatosensory exercises, habituation, gait exercises, and aerobic conditioning. The treating PT will modify specific exercises as appropriate based on the participant's symptoms.
CAREN TherapyDevice
The CAREN, an FDA-registered exempted Class I device, is a VR-based system which includes a six degree-of-freedom motion platform with an embedded, instrumented treadmill surrounded by an immersive 180-degree screen. The CAREN can display a variety of virtual environments (VEs), where the difficulty level and task requirements can be easily modified by the treating clinician to target patient-specific needs.
Augmented Reality (AR) TherapyDevice
AR head-mounted displays are designed to provide immersive virtual environments similar to the CAREN, but with the portability to be used in most outpatient clinical settings and potentially for at-home therapy as well as significantly reduced cost compared to the CAREN. AR devices have integrated eye-tracking and inertial measurement units (IMUs) which can be used to objectively quantify characteristics of eye, head and body movement.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy (CPT) Group | Active comparator | Each session will include vestibular exercises, customized to address the participant's symptoms of vestibular dysfunction and functional ability. Receives: Other: Conventional Therapy (CPT) |
| CAREN Group | Active comparator | The CAREN group will undergo vestibular physical therapy that will include virtual environment (VE) applications on the CAREN. Receives: Device: CAREN Therapy |
| Augmented Reality (AR) Group | Experimental | The AR group will undergo vestibular physical therapy that will include VE applications on the AR HMD. Receives: Device: Augmented Reality (AR) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessments: Sensory Organization Test (SOT)
Assessment consisting of six different conditions used to measure balance and postural control. This test will be performed on the Neurocom Equitest Balance Manager and administered by a physical therapist. The first three conditions have a fixed surface, but the final three conditions are completed with a sway-referenced surface. The visual input is also changed between conditions, completed with eyes open or closed, or with either a fixed or sway referenced visual surroundings. The composite score, a weighted average of the six conditions, is able to distinguish between individuals that are healthy (higher composite scores) and those with balance deficits (lower composite scores). The test will take approximately 15 minutes to complete and will be administered at evaluation and re-evaluation.
Measured: 6 weeks
Functional Assessments: Community Balance and Mobility Scale (CB&M)
Assessment used to evaluate the performance of 13 tasks for ambulatory individuals with TBI, and has been found to be valid and reliable, and sensitive in this population. Each task is scored on a scale of 0-5 based on the success of task completion, with a maximum score of 96. The tasks evaluated are unilateral stance, tandem walking, 180 degree tandem pivot, lateral foot scooting, hopping forward, crouch and walk, lateral dodging, walking and looking, running with controlled stop, forward to backward walking, walk, look and carry, and descending stairs. This will take approximately 20-30 min to complete and will be administered at evaluation and re-evaluation.
Measured: 6 weeks
Functional Assessments: Functional Gait Assessment (FGA)
Assessment composed of 10 gait tasks, administered and scored on a 0-3 ordinal scale by a physical therapist. Scoring is based on the ability to walk over a level surface, change speed, walk while turning the head, walk and pivot, step over an obstacle (approximately 6" in height), walk with a narrow base of support (heel to toe), walk with eyes closed, walk backwards, and walk up steps, with a lower score indicating a higher degree of impairment. This will take approximately 5-10 minutes to complete and will be administered at evaluation and re-evaluation.
Measured: 6 weeks
Vestibular Symptoms: Activity-Specific Balance Confidence Scale (ABC)
Questionnaire of self-reported balance confidence in daily activities developed to measure the psychological impact of balance impairment and/or falls. Participants score 16 items on a scale of 0% (no confidence) to 100% (total confidence) that they can perform the activity without losing balance. The ABC has been proven to be internally consistent, reliable, and valid. This will take approximately 5 minutes to complete and will be administered at evaluation and re-evaluation.
Measured: 6 weeks
Vestibular Symptoms: Dizziness Handicap Inventory (DHI)
Evaluation of self-perceived handicapping of the effects imposed by dizziness. The DHI is constructed of 25 questionnaire items classified into three subgroups: physical (0-28 points), emotional (0-24 points), and functional (0-48 points). Answers are graded 0-4 with total score ranges from 0 to 100, 100 signifying the highest degree of impairment. The questionnaire has been validated and is sensitive to subtle balance deficits following mild TBI. This will take approximately 10 minutes to complete and will be administered at evaluation and re-evaluation.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Oct 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MTBI - Mild Traumatic Brain InjuryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naval Health Research Center
- Sponsor type
- US federal agency
- Collaborators
- United States Naval Medical Center, San Diego, Walter Reed National Military Medical Center, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Pinata Sessoms, Naval Health Research Center
- Investigators
- Pinata Sessoms, PhD, Principal investigator, Naval Health Research CenterSarah Kruger, MS, Principal investigator, Walter Reed National Military Medical CenterKerry Rosen, PhD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326100
- Sponsor's protocol ID
- WRNMMC-2020-0332
- Acronym
- VR4VPT
- Status last verified
- Nov 2023
- First submitted
- 3 Mar 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual and Augmented Reality Devices in Vestibular Physical Therapy for mTBI
- ClinicalTrials.gov ID
- NCT05326100
- Acronym / sponsor ID
- VR4VPT / WRNMMC-2020-0332
- Keywords
- Virtual Reality, Augmented Reality, Vestibular Physical Therapy, Computer Assisted Rehabilitation Environment (CAREN), Head Mounted Display (HMD), Physical Therapy, MTBI, Servicemember
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Naval Health Research CenterUS federal agency
- Collaborators
- United States Naval Medical Center, San Diego, Walter Reed National Military Medical Center, Congressionally Directed Medical Research Programs
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Apr 2022 (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.
Rapidly evolving virtual reality (VR) and augmented reality (AR) technologies are being incorporated by many large-scale industries, and the medical field is no exception. One area that has gained significant attention in recent years is virtual rehabilitation which allows physical therapists to leverage state-of-the-art immersive virtual environments to uniquely address functional deficits in patients who are unresponsive to conventional treatment techniques. Advanced VR and AR technologies are now available in commercially available small-scale, mobile head-mounted displays which can be readily used in outpatient clinic settings and possibly at home.
The aim of this study is to determine whether advanced VR- and AR-based physical therapy improves functional status and reduces self-reported symptoms in individuals experiencing vestibular disorders secondary to mild traumatic brain injury (mTBI). Study participants will be randomized into treatment groups: 1) conventional therapy, 2) therapy performed using a large-scale VR system (the Computer Assisted Rehabilitation Environment or CAREN), 3) therapy performed using a mobile AR. Upon completion of treatment, groups will be compared to determine functional outcome improvements with respect to static and dynamic balance as well as reduction of vestibular symptoms.
Detailed description
This protocol represents Phase 2 of a project that seeks to implement mobile AR-based technologies into vestibular physical therapy. The Phase 1 protocol (EIRB Number - NHRC.2019.0002) is ongoing and will compare outcomes from the AR-based HMD system (e.g., Magic Leap One) to the VR-based CAREN system. With validated instruments from Phase 1, this pilot prospective, three-armed randomized, interventional clinical trial seeks to incorporate advanced VR- and AR-based technologies as modalities in physical therapy for servicemembers (SMs) with mTBI who also experience vestibular dysfunction. The three arms are: 1) conventional vestibular physical therapy only (CPT), 2) CAREN only (CAREN), and 3) AR HMD only (AR).
Primary:
To determine whether advanced VR- and AR-based therapy, improves functional status and reduces self- reported symptoms in SMs with vestibular dysfunction and a history of mTBI.
Hypothesis: The investigators hypothesize that after completion of vestibular physical therapy, participants in the CAREN and AR groups will have better outcomes than those in the CPT group. In the CAREN and AR groups, the investigators anticipate greater improvements in static and dynamic balance, as measured by the Sensory Organization Test (SOT), Community Balance and Mobility Scale (CB\&M), and Functional Gait Assessment (FGA), as well as decreased vestibular symptoms, as measured by the Dizziness Handicap Inventory (DHI) and Activity-Specific Balance Confidence Scale (ABC).
Secondary:
To determine whether participants in the advanced technology groups demonstrate similar clinical improvements following treatment.
Hypothesis: The investigators hypothesize that after completion of vestibular physical therapy, participants in the CAREN and AR groups will show similar improvements in static and dynamic balance as well as vestibular symptoms; essentially, the investigators believe the VR- and AR-based therapies will be comparable.
Tertiary:
To investigate the user experience associated with utilizing advanced technology for the treatment of vestibular dysfunction.
Hypothesis: The investigators hypothesize that participants in the AR group will have greater satisfaction than the CAREN group, as measured by higher scores on the User Satisfaction Evaluation Questionnaire (USEQ).
Exploratory:
Efforts from this study seek to gather information to justify further implementation of AR-based therapy (using HMDs) as well as the development and incorporation of additional military-relevant tasks, such as return-to-duty tasks and measures to be developed for future research efforts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy (CPT) Group | Active comparator | Other: Conventional Therapy (CPT)Each session will include vestibular exercises, customized to address the participant's symptoms of vestibular dysfunction and functional ability. |
| CAREN Group | Active comparator | Device: CAREN TherapyThe CAREN group will undergo vestibular physical therapy that will include virtual environment (VE) applications on the CAREN. |
| Augmented Reality (AR) Group | Experimental | Device: Augmented Reality (AR) TherapyThe AR group will undergo vestibular physical therapy that will include VE applications on the AR HMD. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women, active duty SMs between 18 and 65 years of age and enrolled in Defense Enrollment Eligibility Reporting System (DEERS)
- History of mTBI based on the Ohio State University Traumatic Brain Injury Identification (OSU TBI-ID)
- Require vestibular physical therapy as determined by a PT
- Normal or corrected vision based on the Snellen Eye Chart of at least 20/40
- Able to consistently follow verbal and written instructions and observe safety precautions
Key exclusion criteria (11 listed)
- History of a moderate or severe TBI (OSU TBI-ID; or DVBIC TBI Screening Tool)
- Under care of a physician for a neurodegenerative diagnosis
- History of seizures or syncope
- Clinical determination of Benign Paroxysmal Positional Vertigo (BPPV)
- Diagnosis of any of the following visual impairments: field cuts, macular degeneration, retinal detachment, diplopia, limited peripheral or central vision, or require prism lenses
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 |
|---|---|---|
| Conventional Therapy (CPT)The exercises may include traditional vestibulo-ocular reflex (VOR) exercises, cervical musculoskeletal exercises, somatosensory exercises, habituation, gait exercises, and aerobic conditioning. The treating PT will modify specific exercises as appropriate based on the participant's symptoms. | Other | Conventional Therapy (CPT) Group |
| CAREN TherapyThe CAREN, an FDA-registered exempted Class I device, is a VR-based system which includes a six degree-of-freedom motion platform with an embedded, instrumented treadmill surrounded by an immersive 180-degree screen. The CAREN can display a variety of virtual environments (VEs), where the difficulty level and task requirements can be easily modified by the treating clinician to target patient-specific needs. | Device | CAREN Group |
| Augmented Reality (AR) TherapyAR head-mounted displays are designed to provide immersive virtual environments similar to the CAREN, but with the portability to be used in most outpatient clinical settings and potentially for at-home therapy as well as significantly reduced cost compared to the CAREN. AR devices have integrated eye-tracking and inertial measurement units (IMUs) which can be used to objectively quantify characteristics of eye, head and body movement. | Device | Augmented Reality (AR) Group |
Primary outcome
Functional Assessments: Sensory Organization Test (SOT)
Time frame: 6 weeks
Assessment consisting of six different conditions used to measure balance and postural control. This test will be performed on the Neurocom Equitest Balance Manager and administered by a physical therapist. The first three conditions have a fixed surface, but the final three conditions are completed with a sway-referenced surface. The visual input is also changed between conditions, completed with eyes open or closed, or with either a fixed or sway referenced visual surroundings. The composite score, a weighted average of the six conditions, is able to distinguish between individuals that are healthy (higher composite scores) and those with balance deficits (lower composite scores). The test will take approximately 15 minutes to complete and will be administered at evaluation and re-evaluation.
Functional Assessments: Community Balance and Mobility Scale (CB&M)
Time frame: 6 weeks
Assessment used to evaluate the performance of 13 tasks for ambulatory individuals with TBI, and has been found to be valid and reliable, and sensitive in this population. Each task is scored on a scale of 0-5 based on the success of task completion, with a maximum score of 96. The tasks evaluated are unilateral stance, tandem walking, 180 degree tandem pivot, lateral foot scooting, hopping forward, crouch and walk, lateral dodging, walking and looking, running with controlled stop, forward to backward walking, walk, look and carry, and descending stairs. This will take approximately 20-30 min to complete and will be administered at evaluation and re-evaluation.
Functional Assessments: Functional Gait Assessment (FGA)
Time frame: 6 weeks
Assessment composed of 10 gait tasks, administered and scored on a 0-3 ordinal scale by a physical therapist. Scoring is based on the ability to walk over a level surface, change speed, walk while turning the head, walk and pivot, step over an obstacle (approximately 6" in height), walk with a narrow base of support (heel to toe), walk with eyes closed, walk backwards, and walk up steps, with a lower score indicating a higher degree of impairment. This will take approximately 5-10 minutes to complete and will be administered at evaluation and re-evaluation.
Vestibular Symptoms: Activity-Specific Balance Confidence Scale (ABC)
Time frame: 6 weeks
Questionnaire of self-reported balance confidence in daily activities developed to measure the psychological impact of balance impairment and/or falls. Participants score 16 items on a scale of 0% (no confidence) to 100% (total confidence) that they can perform the activity without losing balance. The ABC has been proven to be internally consistent, reliable, and valid. This will take approximately 5 minutes to complete and will be administered at evaluation and re-evaluation.
Vestibular Symptoms: Dizziness Handicap Inventory (DHI)
Time frame: 6 weeks
Evaluation of self-perceived handicapping of the effects imposed by dizziness. The DHI is constructed of 25 questionnaire items classified into three subgroups: physical (0-28 points), emotional (0-24 points), and functional (0-48 points). Answers are graded 0-4 with total score ranges from 0 to 100, 100 signifying the highest degree of impairment. The questionnaire has been validated and is sensitive to subtle balance deficits following mild TBI. This will take approximately 10 minutes to complete and will be administered at evaluation and re-evaluation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- 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.
Kerry Rosen, PhD contact
Pinata Sessoms, PhD principal investigator
Naval Health Research Center
Sarah Kruger, MS principal investigator
Walter Reed National Military Medical Center
Kerry Rosen, PhD principal investigator
Walter Reed National Military Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Therapy (CPT), CAREN Therapy and Augmented Reality (AR) Therapy in people with MTBI - Mild Traumatic Brain Injury and Dysfunction of Vestibular System, run by Naval Health Research Center at 3 sites 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 9 inclusion and 11 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 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Pinata Sessoms, PhD (6197674474, pinata.h.sessoms.civ@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessments: Sensory Organization Test (SOT) (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2023.