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

Official title

Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Individuals With Traumatic Brain Injury (TBI)

Overview

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.

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 C-Mill VR+ by Motek
  Participants perform treadmill-assisted walking while interacting with non-immersive, game-like environments displayed on screens attached to the treadmill.
• Device Walk-over-Ground
  This intervention utilizes the HTC VIVE Focus Vision system for a realistic, fully immersive VR-assisted overground gait therapy. The immersive VR environment is designed to mimic real-world scenarios and challenges, enhancing the rehabilitation process by engaging patients in naturalistic gait activities.

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: A confirmed diagnosis of traumatic brain injury (TBI), confirmed by the referring physician.
• 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-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 can be confirmed by their physician or a physical therapist referring to the patient. If a physical therapist makes the referral, the diagnosis must still be officially confirmed by a physician to ensure it meets the study's medical criteria.

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: NCT07038889 · 25423

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗