Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Individuals With Traumatic Brain Injury (TBI)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Step Count
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Conventional Treadmill-Based VR Gait Therapy
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.
干预措施: C-Mill VR+ by Motek (Device)
VR-Assisted Overground Gait Therapy
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.
干预措施: Walk-over-Ground (Device)
结局指标
主要结局
Step Count
时间窗: Continuous tracking from Screening to Week 10
FitBit tracks the number of steps (count) taken by participant.
Travel Distance
时间窗: Continuous tracking from Screening to Week 10
FitBit tracks the total distance (miles) travelled by participant.
Activity Zone Minutes
时间窗: 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).
次要结局
- Mini-Balance Evaluation Systems Test(Baseline, Week 7, Week 10)
- 10-Meter Walk Test(Baseline, Week 7, Week 10)
- 6-Minute Walk Test(Baseline, Week 7, Week 10)
- Dynamic Gait Index(Baseline, Week 7, Week 10)
- Timed Up and Go Test(Baseline, Week 7, Week 10)
- Step-Over Test(Baseline, Week 7, Week 10)
- Step Length(Baseline, Week 7, Week 10)
- Stride Length(Baseline, Week 7, Week 10)
- Stance Percentage(Baseline, Week 7, Week 10)
- Gait Speed(Baseline, Week 7, Week 10)
研究者
Hee-Tae Jung
Assistant Professor, Health Informatics
Indiana University