Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI

Summary

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.

Conditions

• Brain Concussion
• Vestibular Disorder
• Cognition Disorder
• Mild Traumatic Brain Injury

Interventions

DEVICE

Praxis

Praxis' gaze stabilization exercises are delivered via the tablet-based VestAid software that uses the tablet camera to automatically assess compliance in the conduct of vestibulo-ocular reflex exercises. The smooth pursuit, saccade, agility, and dual tasking exercises are delivered in the form of military-themed mixed reality games using the HTC Vive Focus 3 headset.

BEHAVIORAL

Supervised cardiovascular exercise

The supervised cardiovascular exercise does not incorporate gaze stabilization exercises (vestibulo-ocular reflex exercises) or smooth pursuit, saccade, agility, and dual tasking exercises.

Sponsors & Collaborators

• Brooke Army Medical Center

  collaborator FED

• University of Pittsburgh

  collaborator OTHER

• BlueHalo

  lead INDUSTRY

Principal Investigators

• Pedram Hovareshti, PhD · BlueHalo

Study Design

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-12

Primary Completion

2025-04-30

Completion

2025-09-30

Countries

• United States

Study Locations