Virtual Reality Treadmill Training in Individuals With Traumatic Brain Injur : A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Retention Rate
研究概览
简要总结
This pilot study aims to determine the feasibility of a virtual reality treadmill training intervention in individuals with Traumatic Brain Injury (TBI). Participants will be stratified based on age into adults' group or older adults' group and then randomized into the virtual reality treadmill training (intervention) group with feedback or the treadmill training (control) group. This pilot study will also provide preliminary evidence on the impact of the virtual reality treadmill training on mobility, balance, fear of falls, fall risk, attention and physical activity in the community in individuals with TBI. The data collected in this pilot study will also help to estimate sample size for subsequent large clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 90 years old
- •diagnosed with a non-penetrating TBI
- •at least 12 months post most recent injury
- •self-reported balance deficits and fear of falls or at least 2 falls in the last one year
- •Able to understand and speak English language to respond, understand and comply with study procedures throughout the 10-week study period and fill out the study questionnaires in English
- •Able to walk with minimal assistance or less (with bracing and assistive devices as needed)
排除标准
- •history of severe cardiac disease
- •neuromuscular or neurological pathologies other than TBI that limit study participation
- •uncontrolled seizure disorder
- •weight greater than 135 kg or less than 25 kg
- •height greater than 6' 2''
- •severe cognitive, visual or hearing impairment where the patient is not able to follow the study instructions
- •open skin lesion or bandage in the area of C-Mill harness contact
研究组 & 干预措施
VRTT With Feedback - Adults
Adults aged 18-65 with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill with augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.
Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill with AR/VR feedback.
干预措施: C-Mill with AR/VR Guidance (Device)
VRTT With Feedback - Adults
Adults aged 18-65 with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill with augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.
Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill with AR/VR feedback.
干预措施: Zeno 3-Layer Walkway (Device)
VRTT With Feedback - Adults
Adults aged 18-65 with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill with augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.
Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill with AR/VR feedback.
干预措施: Hunova (Device)
VRTT With Feedback - Older Adults
Adults aged 65 and older with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill with augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.
Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill with AR/VR feedback.
干预措施: Hunova (Device)
VRTT With Feedback - Older Adults
Adults aged 65 and older with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill with augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.
Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill with AR/VR feedback.
干预措施: C-Mill with AR/VR Guidance (Device)
VRTT With Feedback - Older Adults
Adults aged 65 and older with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill with augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.
Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill with AR/VR feedback.
干预措施: Zeno 3-Layer Walkway (Device)
VRTT Without Feedback - Adults
Adults aged 18-65 with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill without augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.
Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill without AR/VR feedback.
干预措施: C-Mill without AR/VR Guidance (Device)
VRTT Without Feedback - Adults
Adults aged 18-65 with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill without augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.
Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill without AR/VR feedback.
干预措施: Zeno 3-Layer Walkway (Device)
VRTT Without Feedback - Adults
Adults aged 18-65 with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill without augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.
Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill without AR/VR feedback.
干预措施: Hunova (Device)
VRTT Without Feedback - Older Adults
Adults aged 65 and older with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill without augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.
Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill without AR/VR feedback.
干预措施: C-Mill without AR/VR Guidance (Device)
VRTT Without Feedback - Older Adults
Adults aged 65 and older with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill without augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.
Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill without AR/VR feedback.
干预措施: Zeno 3-Layer Walkway (Device)
VRTT Without Feedback - Older Adults
Adults aged 65 and older with TBI. At Week 1 after baseline, participants will begin study intervention on the C-Mill without augmented/virtual reality (AR/VR) guidance. Starting at Week 2, the study intervention on C-Mill will be repeated 3 sessions/week for 8 weeks.
Each one hour session will include about 15 minutes of standing balance training, about 5 minutes of stepping balance training and about 30 minutes of walking training on the C-Mill without AR/VR feedback.
干预措施: Hunova (Device)
结局指标
主要结局
Retention Rate
时间窗: Up to Week 10
Retention rate defined as the percentage of enrolled participants who completed the study.
Percentage of Participants who Adhere to 100% of Study Procedures
时间窗: Up to Week 10
Recruitment Rate
时间窗: Up to Week 10
Recruitment rate is defined as the number of patients recruited on average for one month in one site.
Enrollment Rate
时间窗: Up to Week 10
Enrollment Rate defined as the percentage of recruited participants who enrolled in the study.
次要结局
- Change from Baseline in Falls Self-Efficacy Scale (FES-I) Score by Final Intervention Visit(Baseline, Week 7)