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

ConditionTraumatic Brain Injury

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

C-Mill VR+ by Motek
Device
Participants perform treadmill-assisted walking while interacting with non-immersive, game-like environments displayed on screens attached to the treadmill.
Walk-over-Ground
Device
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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: VR-Assisted Overground Gait TherapyExperimental treatment 1 intervention

Group B: Conventional Treadmill-Based VR Gait TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

Step Count

FitBit tracks the number of steps (count) taken by participant.

Time frame

Continuous tracking from Screening to Week 10

Travel Distance

FitBit tracks the total distance (miles) travelled by participant.

Time frame

Continuous tracking from Screening to Week 10

Activity Zone Minutes

Fitbit calculates maximum heart rate (HR) from user age (Max HR = 220 - age) and defines Activity Zone thresholds based on percentages of max HR (Fat Burn 50-69%, Cardio/Peak \>70%). Activity Zone Minutes (AZMs) are an intensity-weighted measure of activity. AZM (count) is based on sustained heart rate over time: 1 AZM per minute in the Fat Burn Zone (50-69% max HR) and 2 AZMs per minute in the Cardio/Peak Zones (\>=70% max HR).

Time frame

Continuous tracking from Screening to Week 10

Secondary outcomes

10-Meter Walk Test

10MWT: Subjects will walk a distance of 10 meters at their normal pace while being timed, allowing assessment of gait speed and mobility. (5 minutes)

Time frame

Baseline, Week 7, Week 10

6-Minute Walk Test

6MWT: Subjects will walk for 6 minutes along a 30m track. Subjects may stop and rest as often as needed. Subject walking speed will be collected during the test to evaluate the rate of functional fatigue. (10 minutes)

Time frame

Baseline, Week 7, Week 10

Mini-Balance Evaluation Systems Test

Mini-BESTest: Subjects will complete 14 different tasks ranging from static standing to dynamic walking. All subjects will be guarded closely for safety to prevent falling. (15 minutes)

Time frame

Baseline, Week 7, Week 10

Timed Up and Go Test

TUG: Subjects will rise from a seated position, walk three meters, turn around, walk back to the chair, and sit down. This test is used to assess mobility, balance, walking ability, and fall risk. (5 minutes)

Time frame

Baseline, Week 7, Week 10

Other outcomes

Disability Rating Scale

DRS: Participants will complete a questionnaire assessing the level of disability and functional impairment. NOTE: Only applicable to TBI participants.

Time frame

Screening, Baseline, Week 7, Week 10

Quality of Life after Brain Injury

QoLIBRI: Participants will complete a questionnaire assessing the health-related quality of life specifically tailored for individuals recovering from brain injury.

Time frame

Baseline, Week 7, Week 10

Activities-specific Balance Confidence Scale

ABC: Participants will complete a questionnaire assessing perceived balance confidence during common daily activities.

Time frame

Baseline, Week 7, Week 10

Cybersickness in Virtual Reality Questionnaire

CSQ-VR: Assesses physical symptoms associated with VR exposure, including nausea, dizziness, disorientation, and fatigue.

Time frame

Week 1 and Week 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Indiana University Health

Collaborator

Source ClinicalTrials.gov

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