Traumatic Brain Injury
Conditions
Keywords
Gait Training, Virtual Reality, Traumatic Brain Injury
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.
Interventions
DEVICEC-Mill VR+ by Motek
Participants perform treadmill-assisted walking while interacting with non-immersive, game-like environments displayed on screens attached to the treadmill.
DEVICEWalk-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.
Sponsors
Indiana University
Indiana University Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Mini-Balance Evaluation Systems Test | Baseline, Week 7, Week 10 | 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) |
| 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). |
Countries
United States
Contacts
CONTACTPeter Altenburger, Ph.D., PT
CONTACTHee-Tae Jung, Ph.D.
PRINCIPAL_INVESTIGATORHee-Tae Jung, Ph.D.
Indiana University, Luddy School of Informatics, Computing, and Engineering
PRINCIPAL_INVESTIGATORPeter Altenburger, Ph.D., PT
Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation
Outcome results
None listed