Virtual Reality Gait Rehabilitation for Traumatic Brain Injury

PA
HJ
Overseen ByHee-Tae Jung, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
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 tests a new virtual reality (VR) program designed to help individuals with traumatic brain injuries improve their walking skills in real-life settings. It compares two types of VR therapy: one where participants walk independently using VR headsets and another that involves a treadmill with less immersive VR. The trial seeks individuals with a confirmed TBI or stroke diagnosis, who have not undergone physical therapy in the past month, and have been cleared by a neurologist for exercise. As an unphased trial, this study provides a unique opportunity to explore innovative therapies that could enhance recovery and improve quality of life.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it excludes participants with unstable medication regimens that could interfere with the study. It's best to discuss your specific medications with the trial team.

What prior data suggests that this virtual reality gait rehabilitation is safe for traumatic brain injury patients?

Studies have shown that virtual reality (VR) therapies for aiding mobility are generally safe and well-tolerated by patients. Research on similar programs, such as the Nijmegen Falls Prevention Program, has demonstrated fewer falls and injuries, indicating positive safety outcomes. Although specific data on the new VR-assisted walking therapy in this trial is not yet available, other VR programs for similar purposes have not reported major side effects. This suggests that the treatment may be safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve gait rehabilitation for individuals with traumatic brain injuries using virtual reality. Unlike traditional methods that often involve treadmill exercises with limited interaction, the VR-Assisted Overground Gait Therapy allows participants to walk in an immersive virtual reality environment, simulating real-world conditions. This approach uses the HTC VIVE Pro 2, providing a more engaging and realistic training experience. By comparing this to the conventional treadmill-based VR therapy, the trial aims to determine if the immersive experience can enhance recovery outcomes more effectively.

What evidence suggests that this virtual reality gait rehabilitation is effective for traumatic brain injury?

Research has shown that virtual reality (VR) for walking exercises can help people with traumatic brain injuries (TBI) improve their walking ability. In this trial, participants in the VR-Assisted Overground Gait Therapy arm will engage in gait training within an immersive VR environment, which similar studies have shown to positively affect balance and movement. Meanwhile, the Conventional Treadmill-Based VR Gait Therapy arm will involve treadmill-assisted walking with less immersive virtual scenarios. VR creates realistic walking experiences, enhancing rehabilitation effectiveness. Patients often feel more engaged and motivated in these VR environments, potentially leading to better results compared to traditional methods like treadmill exercises. Overall, VR-based therapies have shown promise in making rehabilitation more effective and enjoyable.12345

Who Is on the Research Team?

HJ

Hee-Tae Jung, Ph.D.

Principal Investigator

Indiana University, Luddy School of Informatics, Computing, and Engineering

PA

Peter Altenburger, Ph.D., PT

Principal Investigator

Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation

Are You a Good Fit for This Trial?

This trial is for individuals with traumatic brain injury or stroke who need gait rehabilitation. They must have a good mental state (MMSE score >24), be cleared by a neurologist, able to consent, and not have had physical therapy in the last month. It's not for those over 2 meters tall, over 135 kg, intolerant to VR, needing significant walking support (FAC <2), on unstable meds, with certain comorbidities or severe sensory impairments.

Inclusion Criteria

Mini-Mental State Examination (MMSE) score greater than 24
Approval from a neurologist for participation in exercise-based interventions
Must be able to provide informed consent for themselves
See 3 more

Exclusion Criteria

Body height more than 2.00 meters
Intolerance to virtual reality environments or motion simulation
My weight is over 135 kg.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Baseline Activity Monitoring

Participants are issued a wearable tracker to gauge baseline activity for at least 5 days

1 week
No additional visits required

Treatment

Participants undergo 12 treatment sessions, 2x a week for 6 weeks, using either VR-assisted overground gait therapy or treadmill-based VR gait therapy

6 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at post-intervention and 1-month follow-up

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Overground Virtual Reality (VR) Gait Rehabilitation
Trial Overview The study tests a new virtual reality-based program against traditional treadmill VR therapy to improve walking abilities in TBI patients. Participants will experience immersive VR-assisted overground gait therapy and compare its effectiveness with non-immersive treadmill-based alternatives.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: VR-Assisted Overground Gait TherapyExperimental Treatment1 Intervention
Group II: Conventional Treadmill-Based VR Gait TherapyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Indiana University Health

Collaborator

Trials
35
Recruited
18,500+

Citations

Overground Virtual Reality (VR) Gait Rehabilitation for ...The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help individuals with traumatic ...
Overground Virtual Reality (VR) Gait Rehabilitation for ...Benefits: Participation in this study may help improve your walking abilities and quality of life if you have experienced a traumatic brain injury. Additionally ...
Overground Virtual Reality (VR) Gait Rehabilitation forThe purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help individuals with traumatic brain injury ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/34698684/
Overground and Virtual Reality Gait Speed Are Associated ...We examined rates of Symptom Validity Test (SVT) failure in active duty military service members with a history of mild-moderate TBI and its impact on gait ...
Effects of Virtual Reality–Assisted and Overground Gait...Effects of Virtual Reality–Assisted and Overground Gait Adaptation Training on Balance and Walking Ability in Stroke Patients. A Randomized Controlled Trial.
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