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NCT Number: NCT07038889

Overground Virtual Reality (VR) Gait Rehabilitation for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health, Neurorehabilitation & Robotics

Indianapolis, Indiana, 46202, United States

Location contact

Hee-Tae Jung, Ph.D.

SUB_INVESTIGATOR

Kathryn Gyves, PT, DPT, NCS, CSRS, AVPT, CBIS

CONTACT

[email protected]

317-963-7050

Peter Altenburger, Ph.D., PT

CONTACT

[email protected]

317-278-0703

Peter Altenburger, Ph.D., PT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

C-Mill VR+ by Motek

Device

Participants perform treadmill-assisted walking while interacting with non-immersive, game-like environments displayed on screens attached to the treadmill.

Walk-over-Ground

Device

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.

Primary outcomes

  1. Step Count

    Time frame: Continuous tracking from Screening to Week 10

    FitBit tracks the number of steps (count) taken by participant.

  2. Travel Distance

    Time frame: Continuous tracking from Screening to Week 10

    FitBit tracks the total distance (miles) travelled by participant.

  3. 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).

Secondary outcomes

  1. 10-Meter Walk Test

    Time frame: Baseline, Week 7, Week 10

    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)

  2. 6-Minute Walk Test

    Time frame: Baseline, Week 7, Week 10

    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)

  3. Dynamic Gait Index

    Time frame: Baseline, Week 7, Week 10

    DGI: 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)

  4. Timed Up and Go Test

    Time frame: Baseline, Week 7, Week 10

    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)

  5. Step-Over Test

    Time frame: Baseline, Week 7, Week 10

    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.

  6. Step Length

    Time frame: Baseline, Week 7, Week 10

    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.

  7. Stride Length

    Time frame: Baseline, Week 7, Week 10

    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.

  8. Stance Percentage

    Time frame: Baseline, Week 7, Week 10

    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.

  9. Gait Speed

    Time frame: Baseline, Week 7, Week 10

    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).

Other outcomes

  1. Quality of Life after Brain Injury

    Time frame: Baseline, Week 7, Week 10

    QoLIBRI: Participants will complete a questionnaire assessing the health-related quality of life specifically tailored for individuals recovering from brain injury.

  2. Disability Rating Scale

    Time frame: Screening, Baseline, Week 7, Week 10

    DRS: Participants will complete a questionnaire assessing the level of disability and functional impairment. NOTE: Only applicable to TBI participants.

  3. Cybersickness in Virtual Reality Questionnaire

    Time frame: Week 1 and Week 6

    CSQ-VR: Assesses physical symptoms associated with VR exposure, including nausea, dizziness, disorientation, and fatigue.

  4. Igroup Presence Questionnaire

    Time frame: Week 1 and Week 6

    IPQ: Measures the user's sense of presence and immersion in VR, such as perceived realism and awareness.

  5. Perceived Walking Experience Questionnaire

    Time frame: Week 1 and Week 6

    PWEQ: Compares walking in VR with real-world walking in terms of comfort, gait differences, and safety concerns. Derived from Horsak et al. (2021) "Overground Walking in a Fully Immersive Virtual Reality".

  6. Virtual Reality System Usability Questionnaire

    Time frame: Week 1 and Week 6

    VRSUQ: Assesses the usability of the VR system, including responsiveness, clarity, and learnability.

  7. NASA Task Load Index

    Time frame: Week 1 and Week 6

    NASA-TLX: Measures perceived task workload.

  8. Interview

    Time frame: Week 1 and Week 6

    Participants will take part in 30-minute semi-structured interviews to share their thoughts on the user experience (e.g. engagement, utility, realism) and provide feedback to improve the virtual reality system.

Study contacts

Contact information is provided by the study sponsor or research team.

Hee-Tae Jung, Ph.D.

CONTACT

[email protected]

317-278-1285

Peter Altenburger, Ph.D., PT

CONTACT

[email protected]

317-278-0703

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana University Health

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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