Recruiting

VR-Assisted Therapy & C-Mill

Sponsor:

Indiana University

Code:

NCT07676578

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Walk-over-Ground

C-Mill VR+ by Motek

Study Details

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

Study ID

NCT07676578

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Walk-over-Ground

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

C-Mill VR+ by Motek

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

Primary outcome measure

  • Step Count [ Time Frame: Continuous tracking from Screening to Week 10 ]
  • Travel Distance [ Time Frame: Continuous tracking from Screening to Week 10 ]
  • Activity Zone Minutes [ Time Frame: Continuous tracking from Screening to Week 10 ]

Central Contacts and Locations

Central contacts

Peter Altenburger, Ph.D., PT

317-278-0703paltenbu@iu.edu

Hee-Tae Jung, Ph.D.

317-278-1285heetjung@iu.edu

Locations

Indiana University Health, Neurorehabilitation & Robotics

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Peter Altenburger, Ph.D., PT

317-278-0703paltenbu@iu.edu

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

317-963-7050kgyves@iuhealth.org

Principal Investigator:

Peter Altenburger, Ph.D., PT

More Information

Sponsor

Indiana University

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Gait Training
  • Virtual Reality
  • Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-17.