← Back to Search

Behavioural Intervention

Praxis for Cognitive Disorders (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

Praxis Trial 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.Check my eligibility

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.See study design

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.

Praxis Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Praxis 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

Find a Location

Who is running the clinical trial?

University of PittsburghOTHER

1,725 Previous Clinical Trials

16,305,771 Total Patients Enrolled

1 Trials studying Cognitive Disorders

22 Patients Enrolled for Cognitive Disorders

Brooke Army Medical CenterFED

119 Previous Clinical Trials

26,529 Total Patients Enrolled

BlueHaloLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research program open to participants aged 60 and above?

"Participants eligible for this investigation must fall within the age range of 18 to 50. It's worth noting that there are a total of 87 studies dedicated to individuals younger than 18 and 352 trials focusing on those older than 65."

Answered by AI

Who meets the criteria to participate in this medical study?

"To be eligible for enrollment in this study, individuals must have sustained a concussion and fall between the ages of 18 and 50. The trial is open to a maximum of 30 participants."

Answered by AI

Is this research study currently accepting new participants?

"As per the information available on clinicaltrials.gov, recruitment for this particular trial is currently closed. The trial's initial posting occurred on February 12th, 2024, with the most recent update made on March 14th, 2024. While enrollment is not active in this study at present, it should be noted that there are a total of 472 ongoing trials seeking participants concurrently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06314464.

All > Concussion