Improving Balance and Mobility After Traumatic Brain Injury: A Randomized Controlled Trial Evaluating High Intensity Step Training
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Walking Speed
研究概览
简要总结
This study will explore whether the types and intensity of the interventions being delivered will yield measurable cognitive benefits in addition to improved mobility and balance.
The study evaluates three therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI): Conventional Gait and Balance Training, high intensity step training, and high intensity step training with virtual reality.
详细描述
Individuals with traumatic brain injury (TBI) walk more slowly, demonstrate greater imbalance, and have reduced endurance. There is strong evidence that a single bout of physical activity has substantial cognitive benefits among older adults and stroke survivors, yet similar studies have not been conducted in TBI. This study will explore whether the types and intensity of the interventions being delivered will yield measurable cognitive benefits in addition to improved mobility and balance.
The study evaluates three therapeutic approaches to improve mobility and balance after TBI: the first approach, Conventional Gait and Balance Training (CGBT), represents the current approach for walking retraining. CGBT focuses on walking training in a variety of conditions, obstacle management training, functional independence training, strength training, and standing dynamic balance training. The second approach, high intensity step training (HIST), focuses on the repetition of stepping at higher cardiovascular intensities and yielding a greater number of steps per training session with promising evidence already published in stroke and spinal cord injury (SCI). The third approach combines virtual reality with HIST, designed to increase cortical excitability while concurrently activating the neuromuscular system.
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
- •TBI definition: damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness (LOC) or post traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination
- •Less than 6 months post injury at time of consent
- •Weight less than 298 pounds and height less than 6'2" (based on treadmill contraindications)
- •Intact skin (no open lesions/bandages) in the area of treadmill harness contact
- •Able to walk ten feet requiring the physical assistance of not more than two people and/or bracing, assistive devices
- •Impaired walking speed of < than 1.4 meters/second
- •Ability to follow directions/standardized instructions
- •Minimum 18 years of age at consent
- •Completing or have completed initial inpatient rehabilitation for TBI
- •O-Log score of at least 20
- •Medically cleared for HIST by a physician
排除标准
- •Uncontrolled cardiopulmonary, metabolic, or infectious disorder
- •History of orthopedic or additional neurological disorder that limited motor function before TBI
- •Any reason that, in the opinion of the study investigators or medical team, would interfere with completing the study protocol such as behavioral concerns
- •Uncontrolled seizure disorder
- •Pregnant or lactating females
- •Current participation in any other interventional trials
- •History of an untreated or a poorly controlled psychiatric condition such as depression, schizophrenia, or bipolar disorder
结局指标
主要结局
Walking Speed
时间窗: 6 Weeks
10 Meter Walk Test (10MWT)
次要结局
- Walking Endurance(6 Weeks)
- Balance(6 Weeks)
- Participant Enjoyment(6 Weeks)