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| Name | Class |
|---|---|
| Indiana University Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-Assisted Overground Gait Therapy | Experimental | 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 Focus Vision, enabling participants to practice walking in real-world environments and gait tasks. |
|
| Conventional Treadmill-Based VR Gait Therapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Step Count | FitBit tracks the number of steps (count) taken by participant. | Continuous tracking from Screening to Week 10 |
| Travel Distance | FitBit tracks the total distance (miles) travelled by participant. | 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). | Continuous tracking from Screening to Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, Week 7, Week 10 |
| 6-Minute Walk Test |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 7, Week 10 |
| Disability Rating Scale |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Altenburger, Ph.D., PT | Contact | 317-278-0703 | paltenbu@iu.edu | |
| Hee-Tae Jung, Ph.D. | Contact | 317-278-1285 | heetjung@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hee-Tae Jung, Ph.D. | Indiana University, Luddy School of Informatics, Computing, and Engineering | Principal Investigator |
| Peter Altenburger, Ph.D., PT | Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health, Neurorehabilitation & Robotics | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
|
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)
| Baseline, Week 7, Week 10 |
| Dynamic Gait Index | 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) | 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) | Baseline, Week 7, Week 10 |
| Step-Over Test | 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. | Baseline, Week 7, Week 10 |
| Step Length | 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. | Baseline, Week 7, Week 10 |
| Stride Length | 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. | Baseline, Week 7, Week 10 |
| Stance Percentage | 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. | Baseline, Week 7, Week 10 |
| Gait Speed | 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). | Baseline, Week 7, Week 10 |
DRS: Participants will complete a questionnaire assessing the level of disability and functional impairment. NOTE: Only applicable to TBI participants.
| Screening, 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. | Week 1 and Week 6 |
| Igroup Presence Questionnaire | IPQ: Measures the user's sense of presence and immersion in VR, such as perceived realism and awareness. | Week 1 and Week 6 |
| Perceived Walking Experience Questionnaire | PWEQ: Compares walking in VR with real-world walking in terms of comfort, gait differences, and safety concerns. Derived from Horsak et al. (2021) "Overground Walking in a Fully Immersive Virtual Reality". | Week 1 and Week 6 |
| Virtual Reality System Usability Questionnaire | VRSUQ: Assesses the usability of the VR system, including responsiveness, clarity, and learnability. | Week 1 and Week 6 |
| NASA Task Load Index | NASA-TLX: Measures perceived task workload. | Week 1 and Week 6 |
| Interview | Participants will take part in 30-minute semi-structured interviews to share their thoughts on the user experience (e.g. engagement, utility, realism) and provide feedback to improve the virtual reality system. | Week 1 and Week 6 |
| Principal Investigator |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |