Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury

NCT05721209 | Suspended

• 1 other identifier: 22-01576
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate

  Recruitment rate is defined as the number of patients recruited on average for one month in one site.

  Up to Week 10

• Enrollment Rate

  Enrollment Rate defined as the percentage of recruited participants who enrolled in the study.

  Up to Week 10

• Retention Rate

  Retention rate defined as the percentage of enrolled participants who completed the study.

  Up to Week 10

• Percentage of Participants who Adhere to 100% of Study Procedures

  Up to Week 10

Secondary Outcomes (1)

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

  Baseline, Week 7

Study Arms (4)

VRTT With Feedback - Adults

EXPERIMENTAL

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.

Device: C-Mill with AR/VR Guidance; Device: Zeno 3-Layer Walkway; Device: Hunova

VRTT With Feedback - Older Adults

EXPERIMENTAL

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.

Device: C-Mill with AR/VR Guidance; Device: Zeno 3-Layer Walkway; Device: Hunova

VRTT Without Feedback - Adults

ACTIVE COMPARATOR

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.

Device: C-Mill without AR/VR Guidance; Device: Zeno 3-Layer Walkway; Device: Hunova

VRTT Without Feedback - Older Adults

ACTIVE COMPARATOR

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.

Device: C-Mill without AR/VR Guidance; Device: Zeno 3-Layer Walkway; Device: Hunova

Interventions

Hunova DEVICE

Used to conduct fall-risk assessment.

VRTT With Feedback - Adults; VRTT With Feedback - Older Adults; VRTT Without Feedback - Adults; VRTT Without Feedback - Older Adults

C-Mill with AR/VR Guidance DEVICE

Treadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training. The AR/VR feedback will include computer generated obstacles and objects projected as images on the treadmill. Participants will be asked to use these projections as stepping cues and step on some images of objects while avoiding stepping on the images of obstacles.

VRTT With Feedback - Adults; VRTT With Feedback - Older Adults

C-Mill without AR/VR Guidance DEVICE

Treadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training.

VRTT Without Feedback - Adults; VRTT Without Feedback - Older Adults

Zeno 3-Layer Walkway DEVICE

Used to conduct mobility assessments to assess temporal and spatial gait parameters during the 6-minute walk test.

VRTT With Feedback - Adults; VRTT With Feedback - Older Adults; VRTT Without Feedback - Adults; VRTT Without Feedback - Older Adults

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 90 years old
• diagnosed with a non-penetrating TBI
• at least 12 months post most recent injury
• self-reported balance deficits and fear of falls or at least 2 falls in the last one year
• Able to understand and speak English language to respond, understand and comply with study procedures throughout the 10-week study period and fill out the study questionnaires in English
• Able to walk with minimal assistance or less (with bracing and assistive devices as needed)

You may not qualify if:

• history of severe cardiac disease
• neuromuscular or neurological pathologies other than TBI that limit study participation
• uncontrolled seizure disorder
• weight greater than 135 kg or less than 25 kg
• height greater than 6' 2''
• severe cognitive, visual or hearing impairment where the patient is not able to follow the study instructions
• open skin lesion or bandage in the area of C-Mill harness contact

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Akhila Veerubhotla, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: May 3, 2023
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)