Virtual Reality Treadmill Training for Traumatic Brain Injury

Overseen By Akhila Veerubhotla, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Severe cardiac disease, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 8 weeks

20 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 2 4 5 7}

Research Team

Akhila Veerubhotla, PhD

Principal Investigator

NYU Langone Health

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.

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

Treatment Details

Interventions

• Virtual Reality Treadmill Training

Trial Overview 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.

Participant Groups

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

A study involving 31 individuals with chronic traumatic brain injury (TBI) found that treadmill training combined with virtual reality is safe and feasible, with no serious adverse events reported during the 4-week intervention.

All participants showed improvements in balance and mobility measures after the training, indicating that both virtual reality and treadmill training could be effective methods for enhancing recovery in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of virtual reality and treadmill training in traumatic brain injury: a randomized controlled pilot trial. Tefertiller, C., Ketchum, JM., Bartelt, P., et al.[2022]

Combining virtual reality with treadmill training significantly improves walking speed, step length, and balance in patients with walking and balance impairments, based on a review of 16 randomized controlled trials involving 829 participants.

This augmented training approach also enhances functional mobility and balance confidence, demonstrating its clinical significance over traditional treadmill-only training.

NCBI (Pubmed)

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. Hao, J., Buster, TW., Cesar, GM., et al.[2023]

A systematic review of 12 studies on virtual reality (VR) for rehabilitation in traumatic brain injury (TBI) patients found moderately positive evidence supporting its effectiveness for improving both motor skills and cognitive function.

The studies included varied in quality, indicating a need for more robust research to conclusively determine the efficacy of VR-enhanced rehabilitation techniques for TBI, suggesting that further exploration of immersive VR methods is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality gaming as a neurorehabilitation tool for brain injuries in adults: A systematic review. Aulisio, MC., Han, DY., Glueck, AC.[2021]

A review of five randomized controlled trials involving 157 patients with traumatic brain injury (TBI) found that virtual reality (VR) interventions did not show superior effectiveness compared to traditional physiotherapy for improving balance and mobility.

The results suggest that while VR has potential benefits for TBI rehabilitation, combining it with other rehabilitation methods may lead to better outcomes, and further research is needed to determine the most effective VR treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for balance and mobility rehabilitation following traumatic brain injury: A systematic review of randomized controlled trials. Alashram, AR., Padua, E., Annino, G.[2022]

Virtual reality (VR) shows promise as a tool for assessing and rehabilitating traumatic brain injury, which currently lacks effective pharmacological treatments.

Advancements in VR technology have made it more accessible and affordable, enabling its use in both clinical settings and daily life, potentially leading to long-term improvements in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for Traumatic Brain Injury. Zanier, ER., Zoerle, T., Di Lernia, D., et al.[2020]

The study involving 78 patients with brain injury found that immersive virtual reality (VR) training is safe, with no serious adverse events reported, although some patients experienced minor issues like dizziness.

Patients who adhered to the VR training (participating 3 or more times) reported higher satisfaction and perceived effectiveness in their recovery from upper limb paralysis compared to those who participated less frequently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. Lim, I., Cha, B., Cho, DR., et al.[2023]

Virtual reality (VR) technology combined with a self-paced treadmill provides a safe and effective way to enhance locomotor training, allowing users to control their walking speed while immersed in various virtual environments.

Preliminary results indicate that healthy individuals experience a strong sense of presence in the VR setting, suggesting that this approach could be beneficial for stroke patients to progressively improve their walking abilities through tailored training protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locomotor rehabilitation in a complex virtual environment. Fung, J., Malouin, F., McFadyen, BJ., et al.[2020]

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]

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]

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

Virtual reality gaming as a neurorehabilitation tool for brain injuries in adults: A systematic review. [2021]

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]

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

Virtual Reality for Traumatic Brain Injury. [2020]

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

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. [2023]

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

Locomotor rehabilitation in a complex virtual environment. [2020]