Virtual Reality Treadmill Training in Individuals with Traumatic Brain Injury

Not Applicable

Recruiting

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

• Registration Number: NCT05721209
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-09
• Study Start: 2023-05-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-12-23
• Study Completion: 2025-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VRTT With Feedback - Older Adults	Zeno 3-Layer Walkway	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.
VRTT Without Feedback - Adults	Hunova	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.
VRTT With Feedback - Adults	Zeno 3-Layer Walkway	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.
VRTT With Feedback - Adults	C-Mill with AR/VR Guidance	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.
VRTT With Feedback - Older Adults	C-Mill with AR/VR Guidance	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.
VRTT Without Feedback - Older Adults	C-Mill without AR/VR Guidance	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.
VRTT Without Feedback - Adults	C-Mill without AR/VR Guidance	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.
VRTT Without Feedback - Adults	Zeno 3-Layer Walkway	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.
VRTT Without Feedback - Older Adults	Hunova	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.
VRTT Without Feedback - Older Adults	Zeno 3-Layer Walkway	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.
VRTT With Feedback - Adults	Hunova	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.
VRTT With Feedback - Older Adults	Hunova	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.

Primary Outcome Measures

Name	Time	Method
Retention Rate	Up to Week 10	Retention rate defined as the percentage of enrolled participants who completed the study.
Percentage of Participants who Adhere to 100% of Study Procedures	Up to Week 10
Recruitment Rate	Up to Week 10	Recruitment rate is defined as the number of patients recruited on average for one month in one site.
Enrollment Rate	Up to Week 10	Enrollment Rate defined as the percentage of recruited participants who enrolled in the study.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Falls Self-Efficacy Scale (FES-I) Score by Final Intervention Visit	Baseline, Week 7	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States