Virtual Reality Treadmill Training for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)

Overseen by Akhila Veerubhotla, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NYU Langone Health

Disqualifiers: Severe cardiac disease, Seizure disorder, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This pilot study aims to determine the feasibility of a virtual reality treadmill training intervention in individuals with Traumatic Brain Injury (TBI). Participants will be stratified based on age into adults' group or older adults' group and then randomized into the virtual reality treadmill training (intervention) group with feedback or the treadmill training (control) group. This pilot study will also provide preliminary evidence on the impact of the virtual reality treadmill training on mobility, balance, fear of falls, fall risk, attention and physical activity in the community in individuals with TBI. The data collected in this pilot study will also help to estimate sample size for subsequent large clinical trial.

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

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Virtual Reality Treadmill Training for Traumatic Brain Injury?

Research suggests that combining virtual reality with treadmill training can improve walking and balance in people with traumatic brain injuries. This approach is considered safe and may be more effective than traditional treadmill training alone.

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Is Virtual Reality Treadmill Training safe for humans?

Research shows that Virtual Reality Treadmill Training is generally safe for people with brain injuries, with no serious adverse events reported. Some participants experienced mild side effects like dizziness, but overall satisfaction with the training was high.

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How is Virtual Reality Treadmill Training different from other treatments for traumatic brain injury?

Virtual Reality Treadmill Training combines treadmill walking with virtual reality, providing an immersive experience that enhances balance and mobility rehabilitation. This approach is unique because it offers a safe and engaging way to practice walking in varied virtual environments, which can be more effective than traditional treadmill training alone.

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Eligibility Criteria

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.

Inclusion Criteria

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

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

I am between 18 and 90 years old.

Exclusion Criteria

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

You are taller than 6 feet 2 inches.

I have seizures that are not controlled by medication.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants are stratified by age and randomized into intervention or control groups

1 week

Treatment

Participants undergo virtual reality treadmill training with or without feedback, 3 sessions per week for 8 weeks

8 weeks

24 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Participant Groups

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.

Group I: VRTT With Feedback - Older Adults Experimental Treatment 3 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 - Adults Experimental Treatment 3 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 - Adults Active Control 3 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 Adults Active Control 3 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NYU Langone Health New York, NY

Who Is Running the Clinical Trial?

NYU Langone Health Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of virtual reality and treadmill training in traumatic brain injury: a randomized controlled pilot trial. [2022] To evaluate the safety and efficacy of treadmill training with virtual reality compared to treadmill training alone and standard of care balance and mobility treatment in chronic traumatic brain injury (TBI).

2. England pubmed.ncbi.nlm.nih.gov

Virtual reality augments effectiveness of treadmill walking training in patients with walking and balance impairments: A systematic review and meta-analysis of randomized controlled trials. [2023] To systematically summarize and examine current evidence regarding the combination of virtual reality and treadmill training in patients with walking and balance impairments.

3. England pubmed.ncbi.nlm.nih.gov

Virtual reality gaming as a neurorehabilitation tool for brain injuries in adults: A systematic review. [2021] Evidence of the effectiveness of virtual reality (VR) in motor and cognitive rehabilitation for traumatic brain injury (TBI) continues to be mixed. Therefore, we conducted a systematic literature review in accordance with PRISMA guidelines to strategically evaluate the strength of evidence supporting the use of VR as a rehabilitation tool for motor function and cognition in patients with TBI.

4. Scotland pubmed.ncbi.nlm.nih.gov

Virtual reality for balance and mobility rehabilitation following traumatic brain injury: A systematic review of randomized controlled trials. [2022] Balance and mobility deficits are most prevalent impairments in patients with traumatic brain injury (TBI). The evidence has proposed that rehabilitation plays an important role in improving balance and mobility post-TBI. Virtual reality (VR) is a computer technology that provides immersed users to generate feedback such as visual, audio, and haptic.

5. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality for Traumatic Brain Injury. [2020] In this perspective, we discuss the potential of virtual reality (VR) in the assessment and rehabilitation of traumatic brain injury, a silent epidemic of extremely high burden and no pharmacological therapy available. VR, endorsed by the mobile and gaming industries, is now available in more usable and cheaper tools allowing its therapeutic engagement both at the bedside and during the daily life at chronic stages after injury with terrific potential for a longitudinal disease modifying effect.

6. United States pubmed.ncbi.nlm.nih.gov

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. [2023] Objective: This study was conducted to demonstrate the safety and usability of an immersive virtual reality (VR) game as a rehabilitative training by assessing adverse events (AEs), adherence, and satisfaction in patients with brain injury who had free optional opportunities. Materials and Methods: The results were analyzed retrospectively. Seventy-eight patients with brain injury, undergoing rehabilitation treatment for motor impairment, were recruited. Among them, 51 were available for postintervention survey. The immersive type of VR training was programmed to facilitate use of the paralyzed upper extremity through a fishing simulation game. The Oculus Rift was used as head-mounted display device. Patients were observed for any AEs as defined in the Common Terminology Criteria for AEs during and after each VR training session. A postintervention telephone survey was done to investigate adherence-related factors and safety. Results: The results were analyzed after dividing the patients into nonadherence (patients participated <3 times) and high-adherence (≥3 times) groups. No serious AEs were reported during and after the VR training, and several patients reported other AEs, predominantly dizziness, with one case requiring cessation of VR training. Overall, the satisfaction rate was 54%. Compared with the nonadherence group, the high-adherence group expressed higher satisfaction with VR training, regarded it as effective for recovery from upper limb paralysis, accepted VR as comprehensible, and considered the level of difficulty to be appropriate (P < 0.05). Conclusion: Immersive VR training appeared to be safe for patients with brain injury.

7. United States pubmed.ncbi.nlm.nih.gov

Locomotor rehabilitation in a complex virtual environment. [2020] Virtual reality (VR) technology offers a new and safe way to increase practice time and provide the varied environments and constraints needed to optimize locomotor training. Our specific objectives are (1) to create a virtual environment (VE) coupled with a self-paced treadmill for locomotor training; (2) to compare temporal and distance measurements of gait during treadmill walking while looking at different scenarios of VE; and (3) to develop a protocol optimized for the training of locomotor disorders after stroke. A motorized treadmill was mounted on a six-degree-of-freedom motion platform. VEs were created using commercial software (SoftImage) and projected on a large screen, while system control was administered through the CAREN software (Motek BV). The instantaneous treadmill speed and scene progression were servo-controlled. Preliminary results show that healthy subjects are able to have full control of their own walking speed both on the treadmill and within the virtual scene, while experiencing a strong sense of presence. A street crossing training protocol has been developed for locomotor training. It is expected that locomotor training with increasingly complex VEs will allow persons with stroke to increase progressively their locomotor capacity, as required and entrained by the VE.