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Behavioural Intervention

Biofeedback-Based Rehabilitation for Concussions (SuBTyPE Trial)

N/A

Recruiting

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

Must not have

Participants must not be in significant pain during the evaluation (> 7/10 by patient subjective report)

Participants must not have had any major surgeries in the past year or amputation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1 and 8 of study

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My pain level is not above 7 out of 10.

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I haven't had any major surgeries or amputations in the last year.

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I don't have joint pain or injuries that stop me from walking or moving around.

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I have not been hospitalized for a brain injury.

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I don't have any health issues that could affect my balance or vision.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1 and 8 of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Global Impression of Change (PGIC)

Secondary study objectives

Automated Neuropsychological Assessment Metric (ANAM)

Central Sensorimotor Integration Testing (CSMI)

Complex Turning Course (CTC)

+21 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 9Eligibility criteria met