Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury

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

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.

Study Overview

• Status: Suspended
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: C-Mill with AR/VR Guidance; Device: Zeno 3-Layer Walkway; Device: Hunova; Device: C-Mill without AR/VR Guidance

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 to 90 years old
2. diagnosed with a non-penetrating TBI
3. at least 12 months post most recent injury
4. self-reported balance deficits and fear of falls or at least 2 falls in the last one year
5. 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
6. Able to walk with minimal assistance or less (with bracing and assistive devices as needed)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VRTT With Feedback - Adults; 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; 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: 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.
Experimental: VRTT With Feedback - Older Adults; 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; 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: 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.
Active Comparator: VRTT Without Feedback - Adults; 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: 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.; 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.
Active Comparator: VRTT Without Feedback - Older Adults; 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: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Falls Self-Efficacy Scale (FES-I) Score by Final Intervention Visit	FES-I is a 16-item self-assessment of fear of falls in different situations. Each item is ranked on a 4-point Likert scale ranging from 1 (Not at all concerned) to 4 (Very concerned). The total score is the sum of responses and ranges from 16 to 64; lower scores indicate lower fear of falls. A decrease in scores indicates fear of falls decreased over the observational period.	Baseline, Week 7

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Akhila Veerubhotla, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 23, 2026

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 22-01576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Shared data will be aggregated and deidentified. No IPD will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No