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

Launched by BLUEHALO · Mar 14, 2024

Keywords

ClinConnect Summary

This is a small, early-stage study to see if a portable, mixed-reality rehabilitation system called Praxis can help people recovering from a mild traumatic brain injury (mTBI) who still have dizziness or balance problems. In this pilot, 30 service members from the SPaR program will participate. Fifteen with post-acute mTBI and dizziness will use Praxis for four weeks (about 45 minutes a day, five days a week) to practice eye-stability, balance, navigation, and agility. The other 15 will do four weeks of supervised cardiovascular exercise instead. Researchers will compare the two groups to learn whether Praxis is practical, acceptable, and capable of influencing performance in military-relevant tasks, which could guide a larger future study.

Who can join and what to expect: Adults aged 18–50 can be eligible. The Praxis group must be right-handed, in the SPaR program, have a self-reported or clinician-confirmed mTBI, and ongoing dizziness or imbalance. The control group must be in SPaR, also 18–50, but without dizziness. Key exclusions include significant mental impairment, ongoing high pain, pregnancy, or difficulty avoiding alcohol or certain medicines before testing. Participants will complete assessments before and after the four-week period (measuring dizziness, sleep quality, anxiety, PTSD symptoms, spatial orientation, mobility, and military-relevant performance), plus use VestAid to track how well they follow the eye- and movement-exercises. This study is about whether the Praxis approach is doable and acceptable and to gather initial data to plan a larger trial, not about proving a health benefit yet. The study is based at Fort Sam Houston/Joint Base San Antonio with BlueHalo as sponsor and partners at Brooke Army Medical Center and the University of Pittsburgh.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for Praxis Group:
• • Participating in the SPaR Program
• • 18-50 years old
• • Have a self-reported or clinician-confirmed mTBI
• • Have continued complaints of dizziness/imbalance
• • Are right-handed as determined by the Edinburgh Handedness Inventory-Short Form
• Inclusion Criteria for Control Group:
• • Participating in the SPaR Program
• • 18-50 years old
• • No complaints of dizziness/imbalance
• Exclusion Criteria:
• • Having impaired mental capacity (e.g., altered capacity due to administration of any mind-altering substances or stress/life situations)
• • Displaying behavior that would significantly interfere with validity of data collection or safety during the study
• • Reporting significant pain during the evaluation (7/10 by patient subjective report)
• • Being pregnant (balance considerations)
• • Being unable to abstain from the use of alcohol and medications that might impair participant's balance or cerebral blood flow for 24 hours in advance of testing
• • Being mixed or left-handed as determined by the Edinburgh Handedness Inventory-Short Form for the Praxis group undergoing rs-fMRI.