Overground Virtual Reality (VR) Gait Rehabilitation for Stroke

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Walk-over-Ground; Device: C-Mill VR+ by Motek

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Altenburger, Ph.D., PT; Phone Number: 317-278-0703; Email: paltenbu@iu.edu
• Study Contact Backup: Name: Hee-Tae Jung, Ph.D.; Phone Number: 317-278-1285; Email: heetjung@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Health, Neurorehabilitation & Robotics
      • Contact: Peter Altenburger, Ph.D., PT; Phone Number: 317-278-0703; Email: paltenbu@iu.edu
      • Principal Investigator: Peter Altenburger, Ph.D., PT
      • Sub-Investigator: Hee-Tae Jung, Ph.D.
      • Contact: Kathryn Gyves, PT, DPT, NCS, CSRS, AVPT, CBIS; Phone Number: 317-963-7050; Email: kgyves@iuhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Treadmill-Based VR Gait Therapy; 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.	Device: C-Mill VR+ by Motek; Semi-immersive, game-like environments, treadmill gait therapy
Experimental: VR-Assisted Overground Gait Therapy; 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.	Device: Walk-over-Ground; Fully-immersive, real-world environments, overground gait therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step Count	FitBit tracks the number of steps (count) taken by participant.	Continuous tracking from Screening to Week 10
Travel Distance	FitBit tracks the total distance (miles) travelled by participant.	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).	Continuous tracking from Screening to Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	Baseline, Week 7, Week 10
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.	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.	Baseline, Week 7, Week 10
Dynamic Gait Index	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.	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.	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.	Baseline, Week 7, Week 10

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interview	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.	Week 1, Week 4, Week 6
Quality of Life after Brain Injury	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.	Baseline, Week 7, Week 10
Disability Rating Scale	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.	Baseline, Week 7, Week 10
Cybersickness in Virtual Reality Questionnaire	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.	Week 1, Week 4, Week 6
Igroup Presence Questionnaire	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.	Week 1, Week 4, Week 6
Perceived Walking Experience Questionnaire	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."	Week 1, Week 4, Week 6
Virtual Reality System Usability Questionnaire	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.	Week 1, Week 4, Week 6
NASA Task Load Index	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.	Week 1, Week 4, Week 6

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Hee-Tae Jung, Ph.D., Indiana University, Luddy School of Informatics, Computing, and Engineering; Principal Investigator: Peter Altenburger, Ph.D., PT, Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Virtual Reality; Gait Training
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 31406; 1R03HD120509-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No