Mixed Reality Rehabilitation for Traumatic Brain Injury (Praxis Trial)

N/A

Waitlist Available

Led By Pedram Hovareshti, PhD

Research Sponsored by BlueHalo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up acquired every 24 hours during the 4-week intervention period

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test whether a new rehabilitation method called Praxis, which uses wearable sensors and a virtual reality environment, can help military service members with mild Traumatic Brain Injury (mTBI)

Who is the study for?

This trial is for military service members who have suffered a mild Traumatic Brain Injury (mTBI) and are part of the Center for the Intrepid's Special Operations Performance and Recovery Program. Participants should be in the post-acute phase of mTBI to qualify.

What is being tested?

The study tests Praxis, a mixed reality platform with wearable sensors, against supervised cardiovascular exercise to see if it improves multisensory rehabilitation outcomes after mTBI. The program includes gaze stabilization, balance training, spatial navigation, and agility over four weeks.

What are the potential side effects?

Since this trial involves physical exercises within a virtual environment rather than medication or invasive procedures, side effects may include dizziness or motion sickness due to mixed reality interaction but will vary based on individual tolerance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ subjects will be tested after a 4-week intervention period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~subjects will be tested after a 4-week intervention period

This trial's timeline: 3 weeks for screening, Varies for treatment, and subjects will be tested after a 4-week intervention period for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Perceived usability of the Praxis system measured by the System Usability Scale (SUS)

Secondary study objectives

Change in Dizziness Handicap Inventory (DHI) score

Change in Generalized Anxiety Disorder scale (GAD-7) score

Change in Headache Impact Test-6 (HIT-6) score

+11 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: PraxisExperimental Treatment1 Intervention

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)

Group II: ControlActive Control1 Intervention

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)

Do I qualify?Apply below to find out