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Virtual Reality Treadmill Training for Traumatic Brain Injury

N/A

Recruiting

Led By Akhila Veerubhotla, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 to 90 years old

Diagnosed with a non-penetrating TBI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 10

Awards & highlights

Study Summary

This trial investigates if virtual reality treadmill training helps those with Traumatic Brain Injury (TBI) with mobility, balance, fear of falls, fall risk, attention and physical activity. Data gathered will help plan larger study.

Who is the study for?

This trial is for individuals aged 18-90 with a non-penetrating traumatic brain injury (TBI) at least one year old. They must have balance issues or a history of falls, speak English, and be able to walk with minimal help. Excluded are those with severe heart disease, other limiting conditions, uncontrolled seizures, weight outside 25-135 kg range, over 6'2" tall, or severe cognitive/sensory impairments.Check my eligibility

What is being tested?

The study tests virtual reality treadmill training's effect on mobility and balance in TBI patients. Participants will be split by age into adult or older groups and then randomly assigned to either the VR-enhanced training group or regular treadmill training control group.See study design

What are the potential side effects?

Potential side effects may include discomfort from wearing VR equipment, dizziness or motion sickness due to virtual reality exposure, muscle soreness from exercise on the treadmill, and skin irritation where the harness contacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 90 years old.

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I have been diagnosed with a mild traumatic brain injury.

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I have experienced balance issues and fear of falling or have fallen at least twice in the past year.

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I can speak and understand English well enough to follow the study's procedures for 10 weeks.

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I can walk with little help or by using support devices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 10 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Enrollment Rate

Percentage of Participants who Adhere to 100% of Study Procedures

Recruitment Rate

+1 more

Secondary outcome measures

Change from Baseline in Falls Self-Efficacy Scale (FES-I) Score by Final Intervention Visit

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: VRTT With Feedback - Older AdultsExperimental Treatment3 Interventions

Adults aged 65 and older with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill with augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks. Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill with AR/VR feedback.

Group II: VRTT With Feedback - AdultsExperimental Treatment3 Interventions

Adults aged 18-65 with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill with augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks. Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill with AR/VR feedback.

Group III: VRTT Without Feedback - AdultsActive Control3 Interventions

Adults aged 18-65 with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill without augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks. Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill without AR/VR feedback.

Group IV: VRTT Without Feedback - Older AdultsActive Control3 Interventions

Adults aged 65 and older with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill without augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks. Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill without AR/VR feedback.

0 / 5Eligibility criteria met

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Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,578 Total Patients Enrolled

Akhila Veerubhotla, PhDPrincipal InvestigatorNYU Langone Health

Media Library

Virtual Reality Treadmill Training Clinical Trial Eligibility Overview. Trial Name: NCT05721209 — N/A

Traumatic Brain Injury Research Study Groups: VRTT With Feedback - Adults, VRTT Without Feedback - Adults, VRTT Without Feedback - Older Adults, VRTT With Feedback - Older Adults

Traumatic Brain Injury Clinical Trial 2023: Virtual Reality Treadmill Training Highlights & Side Effects. Trial Name: NCT05721209 — N/A

Virtual Reality Treadmill Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05721209 — N/A

Frequently Asked Questions

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

Is this trial currently recruiting participants?

"Clinicaltrials.gov has indicated that this clinical trial is no longer actively searching for participants--originally posted on February 15th 2023, the study was last updated 8 days later. However, there are 311 other medical studies presently in search of volunteers."

Answered by AI

Is this investigation accepting participants under the age of fifty-five?

"This trial is available to patients aged 18-90 but there are divorced clinical trials for minors and those over 65, totalling 290 studies."

Answered by AI

Who is the ideal candidate for this clinical research?

"This trial requires 40 participants of age 18-90 with a non-penetrating traumatic brain injury (TBI). The specific requirements are: aged between eighteen and ninety, have suffered from TBI without penetration damage, be at least one year removed from the most recent incident, reported balance difficulties or more than two falls in twelve months prior to recruitment, capable of comprehending English language instructions and responding to study questions accurately during ten weeks of testing as well as employing assistive devices when needed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury

2023. "Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05721209.

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