Traumatic Brain InjuryNCT05721209
Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injury
A study testing C-Mill with AR/VR Guidance, C-Mill without AR/VR Guidance and Zeno 3-Layer Walkway in people with Traumatic Brain Injury, run by NYU Langone Health at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- C-Mill with AR/VR Guidance, C-Mill without AR/VR Guidance and Zeno 3-Layer Walkway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2023to 23 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- C-Mill with AR/VR Guidance, C-Mill without AR/VR Guidance, Zeno 3-Layer Walkway, Hunova
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Mill with AR/VR GuidanceDevice
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.
C-Mill without AR/VR GuidanceDevice
Treadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training.
Zeno 3-Layer WalkwayDevice
Used to conduct mobility assessments to assess temporal and spatial gait parameters during the 6-minute walk test.
HunovaDevice
Used to conduct fall-risk assessment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: C-Mill without AR/VR Guidance; Device: Zeno 3-Layer Walkway; Device: Hunova |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Recruitment rate is defined as the number of patients recruited on average for one month in one site.
Measured: Up to Week 10
Enrollment Rate
Enrollment Rate defined as the percentage of recruited participants who enrolled in the study.
Measured: Up to Week 10
Retention Rate
Retention rate defined as the percentage of enrolled participants who completed the study.
Measured: Up to Week 10
Percentage of Participants who Adhere to 100% of Study Procedures
Measured: Up to Week 10
Secondary outcomes (1)
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.
Measured: Baseline, Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start3 May 2023
- Primary completion23 Dec 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Why it stopped: Recruitment for this study is temporarily paused due to study staff turnover.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akhila Veerubhotla, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721209
- Sponsor's protocol ID
- 22-01576
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Shared data will be aggregated and deidentified. No IPD will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injur : A Pilot Study
- ClinicalTrials.gov ID
- NCT05721209
- Acronym / sponsor ID
- 22-01576
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment for this study is temporarily paused due to study staff turnover.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 23 Dec 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VRTT With Feedback - Adults | Experimental | Device: C-Mill with AR/VR Guidance, Device: Zeno 3-Layer Walkway, Device: HunovaAdults 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 | Experimental | Device: C-Mill with AR/VR Guidance, Device: Zeno 3-Layer Walkway, Device: HunovaAdults 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 | Active comparator | Device: C-Mill without AR/VR Guidance, Device: Zeno 3-Layer Walkway, Device: HunovaAdults 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 | Active comparator | Device: C-Mill without AR/VR Guidance, Device: Zeno 3-Layer Walkway, Device: HunovaAdults 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 may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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
Key exclusion criteria (7 listed)
- 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''
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-Mill with AR/VR GuidanceTreadmill 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 | VRTT With Feedback - Adults, VRTT With Feedback - Older Adults |
| C-Mill without AR/VR GuidanceTreadmill training system that is a combination of an instrumented treadmill, front display, and a floor projector, allowing functional gait and balance training. | Device | VRTT Without Feedback - Adults, VRTT Without Feedback - Older Adults |
| Zeno 3-Layer WalkwayUsed to conduct mobility assessments to assess temporal and spatial gait parameters during the 6-minute walk test. | Device | VRTT With Feedback - Adults, VRTT With Feedback - Older Adults, VRTT Without Feedback - Adults, VRTT Without Feedback - Older Adults |
| HunovaUsed to conduct fall-risk assessment. | Device | VRTT With Feedback - Adults, VRTT With Feedback - Older Adults, VRTT Without Feedback - Adults, VRTT Without Feedback - Older Adults |
Primary outcome
Recruitment Rate
Time frame: Up to Week 10
Recruitment rate is defined as the number of patients recruited on average for one month in one site.
Enrollment Rate
Time frame: Up to Week 10
Enrollment Rate defined as the percentage of recruited participants who enrolled in the study.
Retention Rate
Time frame: 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
Time frame: Up to Week 10
1 secondary outcome
Change from Baseline in Falls Self-Efficacy Scale (FES-I) Score by Final Intervention Visit
Time frame: Baseline, Week 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No. Shared data will be aggregated and deidentified. No IPD will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akhila Veerubhotla, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Mill with AR/VR Guidance, C-Mill without AR/VR Guidance and Zeno 3-Layer Walkway in people with Traumatic Brain Injury, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Up to Week 10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.