Trial Summary
What is the purpose of this trial?The goal of this comparative pilot study is to provide evidence that Praxis, a portable testbed with low-cost wearable sensors and a mixed reality environment, can deliver effective multisensory rehabilitation exercises with military face-validity in a military service member (SM) population after mild Traumatic Brain Injury (mTBI).
The main questions this comparative pilot study aims to answer are:
* Can the Praxis testbed provide feasible/acceptable 4-week multisensory rehabilitation for SMs with post-acute mTBI?
* Can Praxis detect and influence measurable changes in readiness performance during mTBI recovery?
Fifteen SMs with post-acute mTBI from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will participate in the multisensory vestibular rehabilitation regimen. These SMs will go through 4 weeks of multisensory vestibular rehabilitation including:
* gaze stabilization
* dual-task balance training
* spatial navigation
* agility training
Data from another fifteen SMs, who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise, will be used as the control group.
Researchers will compare the Praxis and Control group to determine if the Praxis group shows improvement over the control group with respect to the military-relevant behavioral performance outcomes and patient-reported symptom scores after the end of the rehabilitation.
Eligibility Criteria
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.Treatment Details
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.
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)
Find a clinic near you
Research locations nearbySelect from list below to view details:
Brooke Army Medical CenterFort Sam Houston, TX
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Who is running the clinical trial?
BlueHaloLead Sponsor
University of PittsburghCollaborator
Brooke Army Medical CenterCollaborator