← Back to Search

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

Must not have

History of severe cardiac disease

Neuromuscular or neurological pathologies other than TBI that limit study participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 10

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I am between 18 and 90 years old.

Select...

I have been diagnosed with a mild traumatic brain injury.

Select...

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

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of serious heart problems.

Select...

I do not have any nerve or muscle conditions affecting my study participation, other than TBI.

Select...

I have seizures that are not controlled by medication.

Select...

My weight is either over 135 kg or under 25 kg.

Select...

I can follow study instructions without help.

Select...

I have an open wound or bandage where the C-Mill harness would touch.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Enrollment Rate

Recruitment Rate

Retention Rate

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 11Eligibility criteria met