Overground Virtual Reality (VR) Gait Rehabilitation for Stroke

NCT07676578 | Recruiting FDA Device

• 2 other identifiers: 314061R03HD120509-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Gait Training; Virtual Reality; Stroke

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 10-Meter Walk Test

  Baseline, Week 7, Week 10

• 6-Minute Walk Test

  Baseline, Week 7, Week 10

• Dynamic Gait Index

  Baseline, Week 7, Week 10

• Timed Up and Go Test

  Baseline, Week 7, Week 10

• Step-Over Test

  Baseline, Week 7, Week 10

Other Outcomes (8)

• Quality of Life after Brain Injury

  Baseline, Week 7, Week 10

• Disability Rating Scale

  Baseline, Week 7, Week 10

• Cybersickness in Virtual Reality Questionnaire

  Week 1, Week 4, Week 6

Study Arms (2)

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.

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.

Device: C-Mill VR+ by Motek

Interventions

Walk-over-Ground DEVICE

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

VR-Assisted Overground Gait Therapy

C-Mill VR+ by Motek DEVICE

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

Conventional Treadmill-Based VR Gait Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Indiana University Health, Neurorehabilitation & Robotics

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Altenburger, Ph.D., PT

CONTACT

317-278-0703; paltenbu@iu.edu

Hee-Tae Jung, Ph.D.

CONTACT

317-278-1285; heetjung@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Health Informatics

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

US (1)