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

Not Applicable

Not yet recruiting

• Conditions: Stroke; Traumatic Brain Injury; Gait Training

• Registration Number: NCT07038889
• Lead Sponsor: Indiana University

Brief Summary

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.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Primary Completion: 2027-06
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Step Count	Continuous tracking from Screening to Week 10	FitBit tracks the number of steps (count) taken by participant.
Travel Distance	Continuous tracking from Screening to Week 10	FitBit tracks the total distance (miles) travelled by participant.
Activity Zone Minutes	Continuous tracking from Screening to Week 10	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).

Secondary Outcome Measures

Name	Time	Method
10-Meter Walk Test	Baseline, Week 7, Week 10	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)
6-Minute Walk Test	Baseline, Week 7, Week 10	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)
Dynamic Gait Index	Baseline, Week 7, Week 10	DGI: 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)
Timed Up and Go Test	Baseline, Week 7, Week 10	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)
Step-Over Test	Baseline, Week 7, Week 10	SOT: Patients will walk over a flat firm surface for 14 meters. The pathway will include a box that is one foot wide. Each participant will complete 10 passes, stepping over the obstacle (box) each time taking about 15 minutes.
Step Length	Baseline, Week 7, Week 10	With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. Step length (centimeters) measures the distance between the heel contact point of one foot to the heel contact point of the other foot.
Stride Length	Baseline, Week 7, Week 10	With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. Stride length (centimeters) measures the distance between successive heel contact points of the same foot.
Stance Percentage	Baseline, Week 7, Week 10	With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. During the gait cycle, each foot alternates between being in contact with the ground (stance phase) and not in contact with the ground (swing phase). Stance percentage (percent) is the proportion of the gait cycle during which a foot remains in the stance phase.
Gait Speed	Baseline, Week 7, Week 10	With the PKMAS Zeno Walkway (ProtoKinetics), participants walk over a 14-foot pressure mat to capture gait kinematics. Gait speed (meters per second) is calculated by dividing the distance walked (meters) by the time taken (seconds).

Trial Locations

Locations (1)

Indiana University Health, Neurorehabilitation & Robotics; 🇺🇸 Indianapolis, Indiana, United States