Traumatic Brain InjuryNCT07038889
Overground Virtual Reality (VR) Gait Rehabilitation for Traumatic Brain Injury (TBI)
A study testing C-Mill VR+ by Motek and Walk-over-Ground in people with Traumatic Brain Injury, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help individuals with traumatic brain injury (TBI) improve their walking abilities in real-world settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- C-Mill VR+ by Motek and Walk-over-Ground
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: A confirmed diagnosis of traumatic brain injury (TBI), confirmed by the referring physician.
- Cognitive Function: Mini-Mental State Examination (MMSE) score ≥ 24 or Montreal Cognitive Assessment (MoCA) score ≥ 20, indicating sufficient cognitive function to participate in the study.
- Exercise Clearance: Approval from a physician for participation in exercise-based interventions.
- Rehabilitation Need: Demonstrates a need for functional rehabilitation.
- Recent Therapy: Participants should not have received physical therapy (PT) within the last month.
- Consent: Must be able to provide informed consent for themselves.
Who cannot join
- Participants with unstable medication regimens that could interfere with their participation in the study.
- Any comorbidity that could interfere with walking or gait training.
- Participation in VR-assisted gait training within the last 6 months.
- Intolerance to virtual reality environments or motion simulation.
- Severe cognitive, visual, or hearing impairments where the participant cannot follow the therapist's instructions.
- More than 135 kg total body weight.
Show all 11Show fewer
- More than 2.00 meters in body height.
- Presence of open skin lesions or bandages in areas that would come into contact with the harness.
- Functional Ambulation Category (FAC): Participants with an FAC score of less than 2 indicate they require physical support from more than one person to walk.
- Clarification:
- The diagnosis of TBI can be confirmed by their physician or a physical therapist referring to the patient. If a physical therapist makes the referral, the diagnosis must still be officially confirmed by a physician to ensure it meets the study's medical criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Health, Neurorehabilitation & Robotics
Indianapolis, Indiana, 46202
Peter Altenburger, Ph.D., PT, 317-278-0703, paltenbu@iu.edu
Kathryn Gyves, PT, DPT, NCS, CSRS, AVPT, CBIS, 317-963-7050, kgyves@iuhealth.org
About this study
Official title: Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Individuals With Traumatic Brain Injury (TBI)
The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help individuals with traumatic brain injury (TBI) improve their walking abilities in real-world settings. By comparing immersive VR-assisted overground gait therapy to contemporary non-immersive, treadmill-based VR therapy (i.e., C-Mill), the investigators aim to determine its effectiveness in enhancing mobility and quality of life for TBI patients.
Read the detailed description
After obtaining consent and screening, eligible participants are randomized to the treatment or control groups.
First, all participants are issued a wearable tracker to gauge baseline activity for at least 5 days.
During the intervention phase, participants undergo 12 treatment sessions, 2x a week for 6 weeks.
Assessments are conducted at pre-intervention, post-intervention, and 1-month followup.
- Conditions
- Traumatic Brain Injury
- Being tested
- C-Mill VR+ by Motek, Walk-over-Ground
- Keywords
- Gait Training, Virtual Reality, Traumatic Brain Injury
- 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 VR+ by MotekDevice
Participants perform treadmill-assisted walking while interacting with non-immersive, game-like environments displayed on screens attached to the treadmill.
Walk-over-GroundDevice
This intervention utilizes the HTC VIVE Focus Vision system for a realistic, fully immersive VR-assisted overground gait therapy. The immersive VR environment is designed to mimic real-world scenarios and challenges, enhancing the rehabilitation process by engaging patients in naturalistic gait activities.
| Study group | Role | What they receive |
|---|---|---|
| VR-Assisted Overground Gait Therapy | Experimental | Participants in the treatment group (VG-AOGT) will engage in gait training within a newly developed immersive virtual reality (VR) environment. This setup features self-propelled overground walking influenced by three different virtual environments designed to mimic real-world conditions. The immersive technology used is HTC VIVE Focus Vision, enabling participants to practice walking in real-world environments and gait tasks. Receives: Device: Walk-over-Ground |
| Conventional Treadmill-Based VR Gait Therapy | Active comparator | Participants in the control group (VR-CTGT) will engage in gait training using C-Mill VR+ technology, which involves treadmill-assisted walking on a treadmill while interacting with less immersive virtual scenarios presented on screens. Receives: Device: C-Mill VR+ by Motek |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step Count
FitBit tracks the number of steps (count) taken by participant.
Measured: Continuous tracking from Screening to Week 10
Travel Distance
FitBit tracks the total distance (miles) travelled by participant.
Measured: Continuous tracking from Screening to Week 10
Activity Zone Minutes
Fitbit calculates maximum heart rate (HR) from user age (Max HR = 220 - age) and defines Activity Zone thresholds based on percentages of max HR (Fat Burn 50-69%, Cardio/Peak >70%).
Activity Zone Minutes (AZMs) are an intensity-weighted measure of activity. AZM (count) is based on sustained heart rate over time: 1 AZM per minute in the Fat Burn Zone (50-69% max HR) and 2 AZMs per minute in the Cardio/Peak Zones (>=70% max HR).
Measured: Continuous tracking from Screening to Week 10
Secondary outcomes (9)
10-Meter Walk Test
10MWT: Subjects will walk a distance of 10 meters at their normal pace while being timed, allowing assessment of gait speed and mobility. (5 minutes)
Measured: Baseline, Week 7, Week 10
6-Minute Walk Test
6MWT: Subjects will walk for 6 minutes along a 30m track. Subjects may stop and rest as often as needed. Subject walking speed will be collected during the test to evaluate the rate of functional fatigue. (10 minutes)
Measured: Baseline, Week 7, Week 10
Mini-Balance Evaluation Systems Test
Mini-BESTest: Subjects will complete 14 different tasks ranging from static standing to dynamic walking. All subjects will be guarded closely for safety to prevent falling. (15 minutes)
Measured: Baseline, Week 7, Week 10
Timed Up and Go Test
TUG: Subjects will rise from a seated position, walk three meters, turn around, walk back to the chair, and sit down. This test is used to assess mobility, balance, walking ability, and fall risk. (5 minutes)
Measured: Baseline, Week 7, Week 10
Step-Over Test
SOT: Patients will walk over a flat firm surface for 14 meters. The pathway will include a box that is one foot wide. Each participant will complete 10 passes, stepping over the obstacle (box) each time taking about 15 minutes.
Measured: Baseline, Week 7, Week 10
Step Length
With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. Step length (centimeters) measures the distance between the heel contact point of one foot to the heel contact point of the other foot.
Measured: Baseline, Week 7, Week 10
Stride Length
With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. Stride length (centimeters) measures the distance between successive heel contact points of the same foot.
Measured: Baseline, Week 7, Week 10
Stance Percentage
With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. During the gait cycle, each foot alternates between being in contact with the ground (stance phase) and not in contact with the ground (swing phase). Stance percentage (percent) is the proportion of the gait cycle during which a foot remains in the stance phase.
Measured: Baseline, Week 7, Week 10
Gait Speed
With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. Gait speed (meters per second) is calculated by dividing the distance walked (meters) by the time taken (seconds).
Measured: Baseline, Week 7, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start9 Oct 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
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 Indiana UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health
- Responsible party
- Principal investigator, Hee-Tae Jung, Indiana University
- Investigators
- Hee-Tae Jung, Ph.D., Principal investigator, Indiana University, Luddy School of Informatics, Computing, and EngineeringPeter Altenburger, Ph.D., PT, Principal investigator, Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038889
- Sponsor's protocol ID
- 25423
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Individuals With Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT07038889
- Acronym / sponsor ID
- 25423
- Conditions
- Traumatic Brain Injury
- Keywords
- Gait Training, Virtual Reality, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health
- Study start
- 9 Oct 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Jun 2025 (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.
The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help individuals with traumatic brain injury (TBI) improve their walking abilities in real-world settings. By comparing immersive VR-assisted overground gait therapy to contemporary non-immersive, treadmill-based VR therapy (i.e., C-Mill), the investigators aim to determine its effectiveness in enhancing mobility and quality of life for TBI patients.
Detailed description
After obtaining consent and screening, eligible participants are randomized to the treatment or control groups.
First, all participants are issued a wearable tracker to gauge baseline activity for at least 5 days.
During the intervention phase, participants undergo 12 treatment sessions, 2x a week for 6 weeks.
Assessments are conducted at pre-intervention, post-intervention, and 1-month followup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-Assisted Overground Gait Therapy | Experimental | Device: Walk-over-GroundParticipants in the treatment group (VG-AOGT) will engage in gait training within a newly developed immersive virtual reality (VR) environment. This setup features self-propelled overground walking influenced by three different virtual environments designed to mimic real-world conditions. The immersive technology used is HTC VIVE Focus Vision, enabling participants to practice walking in real-world environments and gait tasks. |
| Conventional Treadmill-Based VR Gait Therapy | Active comparator | Device: C-Mill VR+ by MotekParticipants in the control group (VR-CTGT) will engage in gait training using C-Mill VR+ technology, which involves treadmill-assisted walking on a treadmill while interacting with less immersive virtual scenarios presented on screens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis: A confirmed diagnosis of traumatic brain injury (TBI), confirmed by the referring physician.
- Cognitive Function: Mini-Mental State Examination (MMSE) score ≥ 24 or Montreal Cognitive Assessment (MoCA) score ≥ 20, indicating sufficient cognitive function to participate in the study.
- Exercise Clearance: Approval from a physician for participation in exercise-based interventions.
- Rehabilitation Need: Demonstrates a need for functional rehabilitation.
- Recent Therapy: Participants should not have received physical therapy (PT) within the last month.
Key exclusion criteria (11 listed)
- Participants with unstable medication regimens that could interfere with their participation in the study.
- Any comorbidity that could interfere with walking or gait training.
- Participation in VR-assisted gait training within the last 6 months.
- Intolerance to virtual reality environments or motion simulation.
- Severe cognitive, visual, or hearing impairments where the participant cannot follow the therapist's instructions.
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 VR+ by MotekParticipants perform treadmill-assisted walking while interacting with non-immersive, game-like environments displayed on screens attached to the treadmill. | Device | Conventional Treadmill-Based VR Gait Therapy |
| Walk-over-GroundThis intervention utilizes the HTC VIVE Focus Vision system for a realistic, fully immersive VR-assisted overground gait therapy. The immersive VR environment is designed to mimic real-world scenarios and challenges, enhancing the rehabilitation process by engaging patients in naturalistic gait activities. | Device | VR-Assisted Overground Gait Therapy |
Primary outcome
Step Count
Time frame: Continuous tracking from Screening to Week 10
FitBit tracks the number of steps (count) taken by participant.
Travel Distance
Time frame: Continuous tracking from Screening to Week 10
FitBit tracks the total distance (miles) travelled by participant.
Activity Zone Minutes
Time frame: Continuous tracking from Screening to Week 10
Fitbit calculates maximum heart rate (HR) from user age (Max HR = 220 - age) and defines Activity Zone thresholds based on percentages of max HR (Fat Burn 50-69%, Cardio/Peak >70%). Activity Zone Minutes (AZMs) are an intensity-weighted measure of activity. AZM (count) is based on sustained heart rate over time: 1 AZM per minute in the Fat Burn Zone (50-69% max HR) and 2 AZMs per minute in the Cardio/Peak Zones (>=70% max HR).
9 secondary outcomes
10-Meter Walk Test
Time frame: Baseline, Week 7, Week 10
6-Minute Walk Test
Time frame: Baseline, Week 7, Week 10
Mini-Balance Evaluation Systems Test
Time frame: Baseline, Week 7, Week 10
Timed Up and Go Test
Time frame: Baseline, Week 7, Week 10
Step-Over Test
Time frame: Baseline, Week 7, Week 10
Step Length
Time frame: Baseline, Week 7, Week 10
Stride Length
Time frame: Baseline, Week 7, Week 10
Stance Percentage
Time frame: Baseline, Week 7, Week 10
Gait Speed
Time frame: Baseline, Week 7, Week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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.
Hee-Tae Jung, Ph.D. principal investigator
Indiana University, Luddy School of Informatics, Computing, and Engineering
Peter Altenburger, Ph.D., PT principal investigator
Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation
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 VR+ by Motek and Walk-over-Ground in people with Traumatic Brain Injury, run by Indiana University 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 11 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: looking for participants now, as of the sponsor's last update on 15 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Altenburger, Ph.D., PT (317-278-0703, paltenbu@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step Count (time frame: Continuous tracking from Screening to Week 10). The study lists 3 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 15 Oct 2026.