NCT05721209

Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury

Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injur : A Pilot Study

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	C-Mill with AR/VR Guidance	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.
DEVICE	C-Mill without AR/VR Guidance	Treadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training.
DEVICE	Zeno 3-Layer Walkway	Used to conduct mobility assessments to assess temporal and spatial gait parameters during the 6-minute walk test.
DEVICE	Hunova	Used to conduct fall-risk assessment.

Timeline

• Start date: 2023-05-03
• Primary completion: 2026-12-23
• Completion: 2026-12-23
• First posted: 2023-02-09
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States