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NCT Number: NCT07676578

Overground Virtual Reality (VR) Gait Rehabilitation for Stroke

The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help stroke survivors 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 stroke survivors.

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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 status: Recruiting

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: Anischemic or hemorrhagic stroke verified by imaging, confirmed by the patient's physician, and 1-6 months post-stroke (subacute phase)
  • Motor Impairment Level: Functional Ambulation Category (FAC) 3-5, showing moderate impairment while still allowing safe participation in gait tasks.
  • 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- and VR-based interventions.
  • Rehabilitation Need: 10-Meter Walk Test <1.0 m/s, as timed by a PT during screening, indicating a need for functional rehabilitation.
  • Consent: Must be able to provide informed consent for themselves.

Exclusion criteria

  • Participants with uncontrolled cardiovascular, orthopedic, or metabolic conditions or unstable medication regimens that could interfere with their participation in the study.
  • Any comorbidity that could interfere with walking or gait training.
  • Participation in robot- or 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.
  • Any other condition deemed unsafe or confounding by investigator, such as pre-existing neurological conditions unrelated to stroke (e.g. Parkinson's, multiple sclerosis), unmanaged pain medications, or acute medical events during the screening period (e.g. recurrent stroke, hospitalization).
  • Individuals who score a 12 or higher on the Disability Rating Scale.
  • Recent Therapy: Participants should not have received physical therapy (PT) within the last month.

Treatment and study plan

Walk-over-Ground

Device

Fully-immersive, real-world environments, overground gait therapy

C-Mill VR+ by Motek

Device

Semi-immersive, game-like environments, treadmill gait therapy

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.

  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.

  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.

  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. 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.

  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

    Participants will complete the Quality of Life after Brain Injury questionnaire assessing the health-related quality of life specifically tailored for individuals recovering from brain injury. The questionnaire includes 37 items. Scores range from 0 to 100, with 0 indicating the worst possible quality of life and 100 indicating the best possible quality of life; higher scores indicate better health-related quality of life.

  2. Disability Rating Scale

    Time frame: Baseline, Week 7, Week 10

    Participants will complete the Disability Rating Scale questionnaire assessing the level of disability and functional impairment. The scale includes 8 items. Scores range from 0 to 29, with 0 indicating no disability and 29 indicating extreme vegetative state; higher scores indicate greater disability and functional impairment.

  3. Cybersickness in Virtual Reality Questionnaire

    Time frame: Week 1, Week 4, Week 6

    Participants will complete the Cybersickness in Virtual Reality Questionnaire assessing physical symptoms associated with VR exposure, including nausea, dizziness, disorientation, imbalance, fatigue, and visual discomfort. The questionnaire includes 6 items rated from 1 to 7. Scores range from 6 to 42; higher scores indicate greater cybersickness symptom intensity.

  4. Igroup Presence Questionnaire

    Time frame: Week 1, Week 4, Week 6

    Participants will complete the Igroup Presence Questionnaire measuring the user's sense of presence and immersion in VR, such as perceived realism and awareness. The questionnaire includes 14 items using a 7-point Likert scale ranging from -3 to +3. Negatively worded items will be reverse-scored. Scores range from -42 to +42; higher scores indicate greater perceived presence.

  5. Perceived Walking Experience Questionnaire

    Time frame: Week 1, Week 4, Week 6

    Participants will complete the Perceived Walking Experience Questionnaire, which compares walking in VR with real-world walking in terms of comfort, gait differences, headset-related limitation, and safety concerns. The questionnaire includes 5 items rated from 1 to 5. Scores range from 5 to 25; higher scores indicate a less favorable perceived VR walking experience in relation to real-world walking. This questionnaire is adapted from Horsak et al. (2021), "Overground Walking in a Fully Immersive Virtual Reality."

  6. Virtual Reality System Usability Questionnaire

    Time frame: Week 1, Week 4, Week 6

    Participants will complete the Virtual Reality System Usability Questionnaire assessing the usability of the VR system, including responsiveness, clarity, learnability, enjoyment, errors, adverse symptoms, and mental burden. The questionnaire includes 9 items rated from 1 to 5. Negatively worded items will be reverse-scored. Scores range from 9 to 45; higher scores indicate greater perceived VR system usability.

  7. NASA Task Load Index

    Time frame: Week 1, Week 4, Week 6

    Participants will complete the National Aeronautics and Space Administration Task Load Index measuring perceived task workload across mental demand, physical demand, temporal demand, performance, effort, and frustration. The questionnaire includes 6 items. Scores range from 0 to 100; higher scores indicate greater perceived workload.

  8. Interview

    Time frame: Week 1, Week 4, 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

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Stroke Survivors

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jul 1, 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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