Rehabilitation Program for Traumatic Brain Injury

(VICTORY-RCT Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 3-week rehabilitation program, the Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP), can assist veterans and first responders with persistent symptoms from traumatic brain injury (TBI) and related issues. Researchers seek to assess whether the program can alleviate these symptoms and enhance participants' quality of life and daily functioning. The trial will compare two groups: one beginning the program immediately and another after a 3-month wait. Veterans and first responders who have experienced TBI symptoms for over six months and are not currently on active military duty may be suitable candidates. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding the program's potential benefits for TBI recovery.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP) is safe for veterans and first responders?

Research has shown that the Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP) is generally well-tolerated by participants. Previous studies found that this program effectively aids recovery from traumatic brain injury (TBI) without major safety concerns.

The program provides comprehensive care, addressing various aspects of a person's health. This approach helps reduce the likelihood of side effects. Reports from participants have not indicated any serious problems related to the program itself. Instead, it appears to enhance overall well-being and quality of life for those involved.

In summary, current evidence suggests that the IORP is safe for people with TBI, with participants typically experiencing benefits without significant risks.12345

Why are researchers excited about this trial?

The Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP) is unique because it offers a holistic approach to treating traumatic brain injury (TBI) by integrating various therapeutic disciplines into a single, cohesive program. Unlike traditional TBI treatments that might focus on isolated therapies such as physical therapy, occupational therapy, or cognitive rehabilitation individually, the IORP combines them into an intensive, comprehensive three-week program. Researchers are excited about this approach because it could lead to more efficient recovery by addressing multiple aspects of TBI simultaneously, potentially reducing recovery time and improving overall outcomes. Additionally, the program's structured yet flexible design allows it to be tailored to individual patient needs, which is a significant step forward in personalized TBI care.

What evidence suggests that the Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP) is effective for reducing symptoms of traumatic brain injury?

Research has shown that the Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP), which participants in this trial may receive, might help ease symptoms of traumatic brain injury (TBI) and related issues. One study found that patients with combat-related TBI who joined a similar intensive outpatient program experienced improvements in their brain injury symptoms and mental health. The program combines different types of therapy, which has proven effective for many patients. Additionally, a case report described a veteran who felt much better, with less stress and pain, after this kind of treatment. These findings suggest that IORP could enhance quality of life and daily functioning for those with long-term TBI.12346

Are You a Good Fit for This Trial?

This trial is for English-speaking military veterans and first responders aged 18 to 65 who have ongoing symptoms from a traumatic brain injury or concussion, and are able to give consent. Participants must meet the rehab program's general requirements.

Inclusion Criteria

* Meets general eligibility requirements for site specific 3-week IORP
I am able to understand and agree to join this study.
* English speaking
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo baseline evaluation and receive recommendations to participate in the IORP

1 week

Control Waiting Period

Participants in the control arm observe a waiting period before starting the IORP

3 months

Treatment

Participants in the intervention arm undergo a 3-week Interdisciplinary Outpatient Rehabilitation Program (IORP)

3 weeks
Multiple visits for surveys, blood draws, and MRI scans

Follow-up

Participants are monitored for changes in neurobehavioral symptoms and life satisfaction

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP)

Trial Overview

The study tests whether a 3-week interdisciplinary outpatient rehab program (IORP) can reduce long-term TBI symptoms and improve quality of life in veterans and first responders, compared to usual care. Some participants may also have blood draws or MRI scans.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Interdisciplinary Outpatient Rehabilitation Program Intervention ArmExperimental Treatment1 Intervention
Group II: Control Waiting Period ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

University of North Carolina, Chapel Hill

Collaborator

Trials
1,588
Recruited
4,364,000+

University of Florida

Collaborator

Trials
1,428
Recruited
987,000+

University of California, San Diego

Collaborator

Trials
1,215
Recruited
1,593,000+

Moss Rehabilitation Research Institute

Collaborator

Trials
12
Recruited
10,100+

University of Colorado Denver - Anschutz Medical Campus (UCD-AMC)

Collaborator

Citations

Veteran's Interdisciplinary Care for Traumatic Brain Injury and ...

The goal of this clinical trial is to learn if the Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP) can reduce

2024 Annual Report

Our TBI centers clinical care provides specialized, interdisciplinary care for mild-to-moderate traumatic brain injuries and changes in psychological health ...

Efficacy of an Interdisciplinary Intensive Outpatient Program in ...

Efficacy of an interdisciplinary intensive outpatient program in treating combat-related traumatic brain injury and psychological health conditions.

4.

avalonactionalliance.org

avalonactionalliance.org/resources/

Resources

Explore our collection of articles, research papers, partner studies and reports, clinical trial data, and more.

Rehabilitation Program for Traumatic Brain Injury · Info ...

The goal of this clinical trial is to learn if the Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP) can ...

6.

avalonactionalliance.org

avalonactionalliance.org/

Avalon Action Alliance

Traumatic Brain Injury (TBI). Avalon's alliance of TBI centers begin care with an accurate assessment with clear navigation to proven solutions to treat TBI and ...