Mixed Reality Rehabilitation for Traumatic Brain Injury

(Praxis Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: BlueHalo

Must not be taking: Mind-altering substances, Alcohol

Disqualifiers: Impaired mental capacity, Significant pain, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to avoid alcohol and medications that might affect balance or blood flow to the brain for 24 hours before testing.

What data supports the effectiveness of the treatment Portable Mixed Reality-based Platform for Traumatic Brain Injury?

Research shows that mixed reality systems can enhance cognitive therapy and motor recovery in stroke patients, suggesting potential benefits for those with traumatic brain injury. These systems provide engaging environments that promote neural plasticity (the brain's ability to adapt) and improve movement quality, which could be beneficial for rehabilitation. ^{1 2 3 4 5}

Is mixed reality rehabilitation generally safe for humans?

Research on mixed reality rehabilitation, including studies on stroke and walking interventions, suggests it is generally safe for humans. Participants in these studies did not experience increased variability in walking speed or other adverse effects, indicating a good safety profile. ^{2 3 4 5 6}

How is the Portable Mixed Reality-based Platform treatment different from other treatments for traumatic brain injury?

This treatment is unique because it uses a mixed reality system to create an interactive and engaging environment for rehabilitation, which can be customized for intensive training of movements and cognitive tasks. Unlike traditional therapies, it provides real-time feedback and gamified tasks to enhance motor and cognitive recovery, making it more engaging and potentially more effective. ^{1 2 5 7 8}

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.

Research Team

Pedram Hovareshti, PhD

Principal Investigator

BlueHalo

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.

Inclusion Criteria

Participating in the SPaR Program

Have a self-reported or clinician-confirmed mTBI

Have continued complaints of dizziness/imbalance

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 weeks of multisensory vestibular rehabilitation including gaze stabilization, dual-task balance training, spatial navigation, and agility training

4 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Portable Mixed Reality-based Platform

Trial Overview 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.

Participant Groups

Group I: Praxis Experimental Treatment 1 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: Control Active Control 1 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)

Who Is Running the Clinical Trial?

BlueHalo

Lead Sponsor

Trials

2

Recruited

110+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

Findings from Research

Interactive multimodal rehabilitation using a Mixed Reality system may improve cognitive therapy outcomes for stroke patients by promoting neural plasticity during recovery.

Initial results from a trial with 14 participants indicate that this system could also benefit individuals with traumatic brain injury (TBI), showing promise for broader applications in cognitive rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Therapy Using Mixed Reality for Those Impaired by a Cerebrovascular Accident (CVA). Salva, AM., Wiederhold, BK., Alban, AJ., et al.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive Therapy Using Mixed Reality for Those Impaired by a Cerebrovascular Accident (CVA). [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Adaptive mixed reality rehabilitation improves quality of reaching movements more than traditional reaching therapy following stroke. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Mixed-reality exercise effects on participation of individuals with spinal cord injuries and developmental disabilities: a pilot study. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Wearable Mixed Reality Platform to Augment Overground Walking: A Feasibility Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effect of a mixed reality-based intervention on arm, hand, and finger function on chronic stroke. [2018]

6. Sweden pubmed.ncbi.nlm.nih.gov

DO YOUTHS WITH NEUROMOTOR DISORDER AND THEIR THERAPISTS PREFER A MIXED OR VIRTUAL REALITY HEAD-MOUNTED DISPLAY? [2022]

7. England pubmed.ncbi.nlm.nih.gov

An augmented reality system for upper-limb post-stroke motor rehabilitation: a feasibility study. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

BioTrak virtual reality system: effectiveness and satisfaction analysis for balance rehabilitation in patients with brain injury. [2016]