Overground Virtual Reality (VR) Gait Rehabilitation for Traumatic Brain Injury (TBI)

Indiana University

Status: Not yet enrolling

Conditions: Traumatic Brain Injury; Stroke; Gait Training

Treatments: Device: C-Mill VR+ by Motek; Device: Walk-over-Ground

Study type: Interventional

Funder types: Other

Identifiers

NCT07038889

25423

Details and patient eligibility

About

The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help individuals with traumatic brain injury (TBI) 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 TBI patients.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis: A confirmed diagnosis of traumatic brain injury (TBI) or stroke, confirmed by the referring neurologist.
• Cognitive Function: Mini-Mental State Examination (MMSE) score greater than 24, indicating sufficient cognitive function to participate in the study.
• Exercise Clearance: Approval from a neurologist for participation in exercise-based interventions.
• Rehabilitation Need: Demonstrates a need for functional rehabilitation.
• Recent Therapy: Participants should not have received physical therapy (PT) within the last month.
• Consent: Must be able to provide informed consent for themselves.

Exclusion criteria

• Participants with unstable medication regimens that could interfere with their participation in the study.
• Any comorbidity that could interfere with walking or gait training.
• Participation in 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.
• More than 135 kg total body weight.
• More than 2.00 meters in body height.
• Presence of open skin lesions or bandages in areas that would come into contact with the harness.
• Functional Ambulation Category (FAC): Participants with an FAC score of less than 2 indicate they require physical support from more than one person to walk.

Clarification:

• The diagnosis of TBI or stroke can be confirmed by their neurologist or a physical therapist referring to the patient. If a physical therapist makes the referral, the diagnosis must still be officially confirmed by a neurologist to ensure it meets the study's medical criteria.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

VR-Assisted Overground Gait Therapy

Experimental group

Description:

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 Pro 2, enabling participants to practice walking in real-world environments and gait tasks.

Treatment:

Device: Walk-over-Ground

Conventional Treadmill-Based VR Gait Therapy

Active Comparator group

Description:

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.

Treatment:

Device: C-Mill VR+ by Motek