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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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
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

Recruiting Locations

Indiana University Health, Neurorehabilitation & Robotics
Indianapolis, Indiana 46202
Contact:
Peter Altenburger, Ph.D., PT
317-278-0703
paltenbu@iu.edu

More Details

Status
Recruiting
Sponsor
Indiana University

Study Contact

Peter Altenburger, Ph.D., PT
317-278-0703
paltenbu@iu.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.