A Substitute Vestibular Information System Using the BrainPort® Balance Device for Adults With Chronic Vestibular Dysfunction Following Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Dynamic Gait Index
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the BrainPort balance device in improving balance in people with balance deficits due to stroke.
详细描述
Following baseline assessments, subjects participate in 5 consecutive days (10 hours) of clinic training with the BrainPort balance device with a Physical Therapist. Assessments are repeated at the end of clinic training. Following clinic training, subjects take the device home to use for two (2) 20 minute training sessions each day. Subjects return to the clinic for one (1) day of testing after using the device at home for 7 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •At least 18 years old.
- •Diagnosis of stroke for at least 6 months.
- •Reached a plateau and been discharged from physical therapy.
- •Able to ambulate with or without assistance.
- •Ongoing balance problem.
- •Able to read and understand the informed consent form, and willing to sign the informed consent form.
排除标准
- •Current oral health problems as determined by health questionnaire and an examination of the oral cavity.
- •Any medical condition that would interfere with performance on the assessments.
- •History of seizures.
- •Pregnancy.
- •Cognitive deficits (Mini-Mental 25 or below), joint replacements, cervical vertigo, or major neurologic disease, major depression or disabling psychiatric disorder.
- •Known neuropathies of tongue or skin tactile system.
- •Prior exposure to BrainPort® balance device.
- •Subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit.
- •Subjects who have undergone middle ear or other surgery with sacrifice or damage to the chorda tympani nerve, lingual nerve, or hypoglossal nerve.
结局指标
主要结局
Dynamic Gait Index
时间窗: baseline, 5 days, end of study
Berg Balance Scale
时间窗: Baseline, 5 days, end of study
Activities-specific Balance Confidence Scale
时间窗: Baseline, 5 days, end of study
Timed Up and Go
时间窗: Baseline, 5 days, end of study
Stroke Impact Scale
时间窗: Baseline, 5 day, end of study
次要结局
未报告次要终点