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Behavioural Intervention
Vestibular Therapy Augmented with Audio and Visual Real-Time Biofeedback for Rehabilitation (SuBTyPE Trial)
N/A
Waitlist Available
Led By Laurie A King, PhD, DPT
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have a diagnosis of mTBI based on VA/DoD criteria
Participants must be between 18-50 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1 and 8 of study
Awards & highlights
SuBTyPE Trial Summary
This trial aims to improve the assessment and treatment of people with mild traumatic brain injury (mTBI) using wearable sensors. The study will provide immediate feedback on movement quality during physical therapy using visual and
Who is the study for?
This trial is for individuals with mild Traumatic Brain Injury (mTBI), including balance disorders and concussions. Participants should be seeking treatment for these conditions and are willing to undergo physical therapy with wearable technology that provides real-time feedback.Check my eligibility
What is being tested?
The study compares standard vestibular therapy for mTBI against the same therapy augmented with audiovisual biofeedback provided by wearable sensors. The goal is to see if immediate feedback during exercises can improve recovery of movement quality, balance, and walking.See study design
What are the potential side effects?
Potential side effects include an increase in symptoms related to mTBI or balance issues, such as dizziness or headaches. There's also a small risk of falling during the physical therapy sessions.
SuBTyPE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a mild traumatic brain injury according to VA/DoD standards.
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I am between 18 and 50 years old.
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I can see well enough to read and do daily tasks without help.
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I can stand by myself for at least 10 minutes.
SuBTyPE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 1 and 8 of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1 and 8 of study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient Global Impression of Change (PGIC)
Secondary outcome measures
Automated Neuropsychological Assessment Metric (ANAM)
Central Sensorimotor Integration Testing (CSMI)
Complex Turning Course (CTC)
+21 moreSuBTyPE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Vestibular Therapy Augmented with Audio and Visual Real-Time BiofeedbackExperimental Treatment1 Intervention
This arm will receive 12 sessions over 6-weeks of vestibular therapy for mTBI (concussion) based on clinical practice guidelines augmented with visual and audio real-time biofeedback.
Group II: Vestibular Therapy-Standard of CareActive Control1 Intervention
This arm will receive 12 sessions of vestibular physical therapy over 6-weeks based on clinical practice guidelines for mTBI (concussion).
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Who is running the clinical trial?
United States Department of DefenseFED
867 Previous Clinical Trials
327,262 Total Patients Enrolled
Oregon Health and Science UniversityLead Sponsor
979 Previous Clinical Trials
7,386,361 Total Patients Enrolled
1 Trials studying Rehabilitation
65 Patients Enrolled for Rehabilitation
Laurie A King, PhD, DPTPrincipal InvestigatorOregon Health and Science University
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