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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality treadmill training can help individuals with Traumatic Brain Injury (TBI) improve mobility, balance, and confidence in avoiding falls. Participants will join one of two groups: one using virtual reality feedback and one without. The researchers aim to determine if the virtual reality component enhances recovery and to collect data for future larger studies. Suitable candidates have experienced a non-penetrating TBI, struggle with balance, fear falling, or have had at least two falls in the past year. As an unphased trial, this study offers participants the chance to contribute to innovative research that could shape future treatments.

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 prior data suggests that this virtual reality treadmill training is safe for individuals with traumatic brain injury?

Research shows that a virtual reality treadmill is generally safe for people with traumatic brain injury (TBI). Studies indicate that participants handle this type of training well. In fact, those who tried it not only managed it well but also improved their balance and mobility. Serious side effects are rare, making it a promising option for those seeking to enhance their recovery. For those considering joining a trial with this treatment, current evidence suggests it is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality Treadmill Training (VRTT) for traumatic brain injury (TBI) because it introduces a novel approach to rehabilitation through augmented and virtual reality (AR/VR) technology. Unlike traditional therapies that rely on physical exercises and balance training without digital enhancements, VRTT incorporates AR/VR to provide real-time feedback and immersive environments. This innovative method could improve engagement and motivation, potentially accelerating recovery by enhancing motor skills and balance more effectively than conventional treatments. Additionally, the use of a treadmill combined with AR/VR offers a unique platform for tailored, interactive rehabilitation, offering hope for improved outcomes for both adults and older adults with TBI.

What evidence suggests that virtual reality treadmill training is effective for traumatic brain injury?

Research has shown that combining virtual reality with treadmill exercises can help people with traumatic brain injury (TBI) improve their balance and mobility. In this trial, some participants will receive Virtual Reality Treadmill Training (VRTT) with augmented/virtual reality (AR/VR) feedback, while others will receive VRTT without it. One study found that integrating virtual reality with treadmill training reduced the risk of falls and improved balance more effectively than treadmill use alone. Another study confirmed that this training is safe and practical for people with TBI. These findings suggest that adding virtual reality feedback to treadmill exercises could enhance recovery by improving mobility and balance. ^{1 2 3 5 6}

Who Is on the Research Team?

Akhila Veerubhotla, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 have been diagnosed with a mild traumatic brain injury.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05721209

Virtual Reality Treadmill Training in Individuals with ... This pilot study aims to determine the feasibility of a virtual reality treadmill training intervention in individuals with Traumatic Brain Injury (TBI).

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35834738/

Feasibility of virtual reality and treadmill training in ... Virtual reality and treadmill training are safe and feasibile for individuals with TBI. Participants show improvements on balance and mobility measures ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11119161/

Virtual Reality-Based Interventions to Improve Balance in ... One study aimed to compare the safety and effectiveness of virtual reality-based treadmill training with treadmill training alone and the ...

4. researchgate.net researchgate.net/publication/362009351_Feasibility_of_virtual_reality_and_treadmill_training_in_traumatic_brain_injury_a_randomized_controlled_pilot_trial

Feasibility of virtual reality and treadmill training in ... Objective: To evaluate the safety and efficacy of treadmill training with virtual reality compared to treadmill training alone and standard ...

5. liebertpub.com liebertpub.com/doi/10.1089/g4h.2023.0162

C-Mill Virtual Reality/Augmented Reality Treadmill Training ... Conclusions: This study concluded that C-Mill VR/AR treadmill training is effective in improving balance control and reducing the fall risk in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05130658

Study to Improve Ambulation in Individuals With TBI Using ... The purpose of this research study is to test the effectiveness of virtual reality (VR) based treadmill training on walking ability.