Overground Virtual Reality (VR) Gait Rehabilitation for Stroke

Official title

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

Overview

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.

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.

Interventions

• Device Walk-over-Ground
  Fully-immersive, real-world environments, overground gait therapy
• Device C-Mill VR+ by Motek
  Semi-immersive, game-like environments, treadmill gait therapy

Primary outcome measures

• 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]

Secondary outcome measures (9)

• 10-Meter Walk Test [Time frame: Baseline, Week 7, Week 10]
• 6-Minute Walk Test [Time frame: Baseline, Week 7, Week 10]
• Dynamic Gait Index [Time frame: Baseline, Week 7, Week 10]
• Timed Up and Go Test [Time frame: Baseline, Week 7, Week 10]
• Step-Over Test [Time frame: Baseline, Week 7, Week 10]
• Step Length [Time frame: Baseline, Week 7, Week 10]
• Stride Length [Time frame: Baseline, Week 7, Week 10]
• Stance Percentage [Time frame: Baseline, Week 7, Week 10]
• Gait Speed [Time frame: Baseline, Week 7, Week 10]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Indiana University Health, Neurorehabilitation & Robotics — Indianapolis

Identifiers

NCT: NCT07676578 · 31406 · 1R03HD120509-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗