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Behavioural Intervention
VR/AR Therapy for Vestibular Dysfunction (VR4VPT Trial)
N/A
Recruiting
Led By Sarah Kruger, MS
Research Sponsored by Naval Health Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to tolerate wearing a full body safety harness
Be older than 18 years old
Must not have
Medications with significant sedating side effects that could impact safety (i.e., Phenobarbital, Ativan, etc.)
Unable to consent for any reason
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether VR and AR based physical therapy can help improve symptoms for people with vestibular disorders caused by mild traumatic brain injury.
Who is the study for?
This trial is for active duty service members aged 18-65 with mild traumatic brain injury (mTBI) who need vestibular physical therapy. Participants must be able to walk unassisted, have normal or corrected vision, follow instructions, and tolerate wearing a safety harness and head-mounted display for an hour.
What is being tested?
The study tests if advanced VR and AR technologies improve balance and reduce symptoms in mTBI patients compared to conventional therapy. It involves three groups: one receiving standard treatment, another using a large-scale VR system called CAREN, and the third using mobile AR technology.
What are the potential side effects?
Potential side effects may include discomfort from wearing headgear, dizziness or nausea due to virtual environments, fatigue from physical exercises, or possible disorientation post-therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can wear a full body safety harness comfortably.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking medications like Phenobarbital or Ativan that cause significant drowsiness.
Select...
I am unable to give consent for medical procedures.
Select...
I have a diagnosed visual impairment such as macular degeneration or retinal detachment.
Select...
I have had seizures or fainting spells in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Functional Assessments: Community Balance and Mobility Scale (CB&M)
Functional Assessments: Functional Gait Assessment (FGA)
Functional Assessments: Sensory Organization Test (SOT)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Augmented Reality (AR) GroupExperimental Treatment1 Intervention
The AR group will undergo vestibular physical therapy that will include VE applications on the AR HMD.
Group II: CAREN GroupActive Control1 Intervention
The CAREN group will undergo vestibular physical therapy that will include virtual environment (VE) applications on the CAREN.
Group III: Conventional Therapy (CPT) GroupActive Control1 Intervention
Each session will include vestibular exercises, customized to address the participant's symptoms of vestibular dysfunction and functional ability.
Find a Location
Who is running the clinical trial?
United States Naval Medical Center, San DiegoFED
108 Previous Clinical Trials
23,115 Total Patients Enrolled
Congressionally Directed Medical Research ProgramsFED
57 Previous Clinical Trials
10,437 Total Patients Enrolled
Walter Reed National Military Medical CenterFED
143 Previous Clinical Trials
33,291 Total Patients Enrolled
Naval Health Research CenterLead Sponsor
18 Previous Clinical Trials
175,290 Total Patients Enrolled
Sarah Kruger, MSPrincipal InvestigatorWalter Reed National Military Medical Center
Kerry Rosen, PhDPrincipal InvestigatorWalter Reed National Military Medical Center
Pinata Sessoms, PhDPrincipal InvestigatorNaval Health Research Center